Moran, Landhing M.; Phillips, Karran A.; Kowalczyk, William J.; Ghitza, Udi E.; Agage, Daniel A.; Epstein, David H.; Preston, Kenzie L.
2016-01-01
Objectives. Aripiprazole blocks psychostimulant seeking in a rat model of relapse. However, in humans, it may increase ongoing use. We tested aripiprazole specifically for relapse prevention. Methadone-maintained outpatients who were abstinent from cocaine in weeks 11-12 were randomized to double-blind aripiprazole (15/mg daily) or placebo in weeks 13-27, after 12 weeks of contingency management. Participants reported craving via ecological momentary We stopped the trial because too few (18 of 41) participants met the abstinence criterion. The results were suggestive that aripiprazole delayed lapse (HR = 0.45, CI95 = 0.14 – 1.42, p = 0.17) and relapse (HR = 0.31. CI95 = 0.07 – 1.27, p = 0.10), but the effects did not reach statistical significance. Unexpectedly, the proportion of participants reporting cocaine craving was higher in the aripiprazole group (Fisher exact p = .026), though frequency of craving was similar in the aripiprazole and placebo groups (1.89% vs. 1.16%, reffect = .43, CI95 = −.08 - .76). The results suggest that in recently abstinent cocaine users, aripiprazole might delay relapse, but might also slightly increase craving. Difficulty in trial implementation underscores the fact that initial abstinence from cocaine is not a trivial hurdle. PMID:27755017
Moran, Landhing M; Phillips, Karran A; Kowalczyk, William J; Ghitza, Udi E; Agage, Daniel A; Epstein, David H; Preston, Kenzie L
2017-02-01
Aripiprazole blocks psychostimulant seeking in a rat model of relapse. However, in humans, it may increase ongoing use. We tested aripiprazole specifically for relapse prevention. Methadone-maintained outpatients who were abstinent from cocaine in weeks 11-12 were randomized to double-blind aripiprazole (15 mg daily) or placebo in weeks 13-27 after 12 weeks of contingency management. Participants reported craving through ecological momentary assessment. We stopped the trial because very few (18/41) participants fulfilled the abstinence criterion. The results suggested that aripiprazole delayed lapse [hazard ratio (HR)=0.45, 95% confidence interval (CI)=0.14-1.42, P=0.17] and relapse (HR=0.31, 95% CI=0.07-1.27, P=0.10), but the effects did not reach statistical significance. Unexpectedly, the proportion of participants reporting cocaine craving was higher in the aripiprazole group (Fisher's exact P=0.026), although the frequency of craving was similar in the aripiprazole and placebo groups (1.89 vs. 1.16%, reffect=0.43, 95% CI=-0.08-0.76). The results suggest that in recently abstinent cocaine users, aripiprazole might delay relapse, but might also slightly increase craving. Difficulty in trial implementation underscores the fact that initial abstinence from cocaine is not a trivial hurdle.
Hooten, W. Michael; Townsend, Cynthia O.; Hays, J. Taylor; Ebnet, Kaye L.; Gauvin, Thomas R.; Gehin, Jessica M.; Laures, Heidi J.; Patten, Christi A.; Warner, David O.
2015-01-01
Current evidence suggests it may be difficult for patients with chronic pain to quit smoking and, based on previous formative work, a 7-session individual and group-based cognitive behavioral (CB) intervention was developed. The primary aim of this randomized controlled pilot trial was to test the hypothesis that abstinence at month 6 would be greater among patients with chronic pain who received the CB intervention compared to a control condition. Upon admission to a 3-week interdisciplinary pain treatment (IPT) program, patients were randomized to receive the CB intervention (n = 30) or the control condition (n = 30). The 7-day point prevalence of self-reported smoking status was assessed at week 3 (upon completion of the 3-week IPT program) and at month 6 in an intent-to-treat analysis. At week 3, 30% (n=9) of patients in the CB condition were abstinent from smoking compared to 10% (n=3) in the control group (P=.104). At month 6, 20% (n=6) of patients who received the CB intervention were abstinent compared to none in the control group (P=.024). At week 3, a significant group by time interaction effect was found where the CB patients experienced greater improvements in self-efficacy from baseline compared to the control group (P=.002). A greater proportion of patients randomized to the CB group completed the IPT program (P=.052). The findings of this pilot trial suggest that integration of a CB-based smoking abstinence intervention into ongoing pain therapy may be an effective treatment for smokers with chronic pain. PMID:24333035
Zahid, Raana; Dogar, Omara; Mansoor, Sonia; Khan, Amina; Kanaan, Mona; Jawad, Mohammed; Ahluwalia, Jasjit S; Siddiqi, Kamran
2017-01-11
Waterpipe tobacco smoking has increased among youth across the globe including in the US, and it continues as a common and traditional form of smoking tobacco in Pakistan. A range of behavioral and pharmacological therapies are available to support people in quitting cigarette smoking; however, little evidence exists for the efficacy of these therapies in achieving abstinence among waterpipe tobacco smokers. The objective of this study is to assess the efficacy of varenicline when added to behavioral support for waterpipe tobacco smoking cessation, by measuring biochemically validated continuous abstinence in waterpipe tobacco smokers. This is a two-arm, double-blind, placebo-controlled randomized trial conducted in four districts in Punjab, Pakistan. Study participants include adults using a waterpipe (with or without concomitant cigarette, bidi or other forms of tobacco smoking) on a daily basis for at least 6 months and who are willing to quit. We will individually randomize 510 participants to one of the two arms of the trial. Participants in the intervention arm will receive varenicline and behavioral support and those in the control arm will receive placebo and behavioral support. The primary outcome will be continuous abstinence for at least 6 months (week 25) which is biochemically verified by a carbon monoxide level of <10 ppm. Secondary outcomes will include biochemically verified 7-day point abstinence at 5, 12 and 25 weeks and any lapses and relapses between the different assessment points. Tertiary outcomes will include assessment of withdrawal symptoms using the Mood and Physical Symptoms Scale (MPSS), smoking dependency using the Lebanon Waterpipe Dependency Scale (LWDS-11) and monitoring adverse outcomes. This is an efficacy trial and would require a subsequent effectiveness trial for a definitive evaluation of the intervention. ISRCTN, ISRCTN94103375 . Registered on 1 December 2015.
Windle, Sarah B.; Dehghani, Payam; Roy, Nathalie; Old, Wayne; Grondin, François R.; Bata, Iqbal; Iskander, Ayman; Lauzon, Claude; Srivastava, Nalin; Clarke, Adam; Cassavar, Daniel; Dion, Danielle; Haught, Herbert; Mehta, Shamir R.; Baril, Jean-François; Lambert, Charles; Madan, Mina; Abramson, Beth L.
2018-01-01
BACKGROUND: Patients who continue to smoke after acute coronary syndrome are at increased risk of reinfarction and death. We previously found use of varenicline to increase abstinence 24 weeks after acute coronary syndrome; here we report results through 52 weeks. METHODS: The EVITA trial was a multicentre, double-blind, randomized, placebo-controlled trial of varenicline for smoking cessation in patients admitted to hospital with acute coronary syndrome. Participants were randomly assigned (1:1) to receive varenicline or placebo for 12 weeks, in conjunction with low-intensity counselling. Smoking abstinence was assessed via 7-day recall, with biochemical validation using exhaled carbon monoxide. Participants lost to follow-up or withdrawn were assumed to have returned to smoking. RESULTS: Among the 302 participants, abstinence declined over the course of the trial, with 34.4% abstinent 52 weeks after acute coronary syndrome. Compared with placebo, point estimates suggest use of varenicline increased point-prevalence abstinence (39.9% v. 29.1%, difference 10.7%, 95% confidence interval [CI] 0.01% to 21.44%; number needed to treat 10), continuous abstinence (31.1% v. 21.2%, difference 9.9%, 95% CI −0.01% to 19.8%) and reduction in daily cigarette smoking by 50% or greater (57.8% v. 49.7%, difference 8.1%, 95% CI −3.1% to 19.4%). Varenicline and placebo groups had similar occurrence of serious adverse events (24.5% v. 21.9%, risk difference 2.7%, 95% CI −7.3% to 12.6%) and major adverse cardiovascular events (8.6% v. 9.3%, risk difference −0.7%, 95% CI −7.8% to 6.5%). INTERPRETATION: Varenicline was efficacious for smoking cessation in this high-risk patient population. However, 60% of patients who received treatment with varenicline still returned to smoking. Trial registration: ClinicalTrials.gov, no. NCT00794573 PMID:29581161
Windle, Sarah B; Dehghani, Payam; Roy, Nathalie; Old, Wayne; Grondin, François R; Bata, Iqbal; Iskander, Ayman; Lauzon, Claude; Srivastava, Nalin; Clarke, Adam; Cassavar, Daniel; Dion, Danielle; Haught, Herbert; Mehta, Shamir R; Baril, Jean-François; Lambert, Charles; Madan, Mina; Abramson, Beth L; Eisenberg, Mark J
2018-03-26
Patients who continue to smoke after acute coronary syndrome are at increased risk of reinfarction and death. We previously found use of varenicline to increase abstinence 24 weeks after acute coronary syndrome; here we report results through 52 weeks. The EVITA trial was a multicentre, double-blind, randomized, placebo-controlled trial of varenicline for smoking cessation in patients admitted to hospital with acute coronary syndrome. Participants were randomly assigned (1:1) to receive varenicline or placebo for 12 weeks, in conjunction with low-intensity counselling. Smoking abstinence was assessed via 7-day recall, with biochemical validation using exhaled carbon monoxide. Participants lost to follow-up or withdrawn were assumed to have returned to smoking. Among the 302 participants, abstinence declined over the course of the trial, with 34.4% abstinent 52 weeks after acute coronary syndrome. Compared with placebo, point estimates suggest use of varenicline increased point-prevalence abstinence (39.9% v. 29.1%, difference 10.7%, 95% confidence interval [CI] 0.01% to 21.44%; number needed to treat 10), continuous abstinence (31.1% v. 21.2%, difference 9.9%, 95% CI -0.01% to 19.8%) and reduction in daily cigarette smoking by 50% or greater (57.8% v. 49.7%, difference 8.1%, 95% CI -3.1% to 19.4%). Varenicline and placebo groups had similar occurrence of serious adverse events (24.5% v. 21.9%, risk difference 2.7%, 95% CI -7.3% to 12.6%) and major adverse cardiovascular events (8.6% v. 9.3%, risk difference -0.7%, 95% CI -7.8% to 6.5%). Varenicline was efficacious for smoking cessation in this high-risk patient population. However, 60% of patients who received treatment with varenicline still returned to smoking. Trial registration: ClinicalTrials.gov, no. NCT00794573. © 2018 Joule Inc. or its licensors.
A randomized trial of employment-based reinforcement of cocaine abstinence in injection drug users.
Silverman, Kenneth; Wong, Conrad J; Needham, Mick; Diemer, Karly N; Knealing, Todd; Crone-Todd, Darlene; Fingerhood, Michael; Nuzzo, Paul; Kolodner, Kenneth
2007-01-01
High-magnitude and long-duration abstinence reinforcement can promote drug abstinence but can be difficult to finance. Employment may be a vehicle for arranging high-magnitude and long-duration abstinence reinforcement. This study determined if employment-based abstinence reinforcement could increase cocaine abstinence in adults who inject drugs and use cocaine during methadone treatment. Participants could work 4 hr every weekday in a workplace where they could earn about $10.00 per hour in vouchers; they were required to provide routine urine samples. Participants who attended the workplace and provided cocaine-positive urine samples during the initial 4 weeks were invited to work 26 weeks and were randomly assigned to an abstinence-and-work (n = 28) or work-only (n = 28) group. Abstinence-and-work participants had to provide urine samples showing cocaine abstinence to work and maintain maximum pay. Work-only participants could work independent of their urinalysis results. Abstinence-and-work participants provided more (p = .004; OR = 5.80, 95% CI = 2.03-16.56) cocaine-negative urine samples (29%) than did work-only participants (10%). Employment-based abstinence reinforcement can increase cocaine abstinence.
Spend today, clean tomorrow: Predicting methamphetamine abstinence in a randomized controlled trial
Murtaugh, Kimberly Ling; Krishnamurti, Tamar; Davis, Alexander L.; Reback, Cathy J.; Shoptaw, Steven
2013-01-01
Objective This secondary analysis of data from a randomized controlled trial tested two behavioral economics mechanisms (substitutability and delay discounting) to explain outcomes using contingency management (CM) for methamphetamine dependence. Frequency and purchase type (hedonic/utilitarian and consumable/durable) of CM payments were also examined. Methods 82 methamphetamine-dependent gay/bisexual men randomly assigned to conditions delivering CM received monetary vouchers in exchange for stimulant-negative urine samples in a 16-week trial requiring thrice weekly visits (Shoptaw et al., 2005). At any visit participants could redeem vouchers for goods. A time-lagged counting process Cox Proportional Hazards model for recurrent event survival analysis examined aspects of the frequency and type of these CM purchases. Results After controlling for severity of baseline methamphetamine use and accumulated CM wealth, as measured by cumulative successful earning days, participants who redeemed CM earnings at any visit (“spenders”) were significantly more likely to produce stimulant-negative urine samples in the subsequent visit, compared to those who did not redeem (“savers”) 1.011* [1.005, 1.017], Z=3.43, p<0.001. Conclusions Findings support the economic concept of substitutability of CM purchases and explain trial outcomes as a function of frequency of CM purchases rather than frequency or accumulated total CM earnings. Promotion of frequent purchases in incentive-based programs should facilitate substitution for the perceived value of methamphetamine and improve abstinence outcomes. PMID:24001246
A Randomized Trial of Employment-Based Reinforcement of Cocaine Abstinence in Injection Drug Users
Silverman, Kenneth; Wong, Conrad J; Needham, Mick; Diemer, Karly N; Knealing, Todd; Crone-Todd, Darlene; Fingerhood, Michael; Nuzzo, Paul; Kolodner, Kenneth
2007-01-01
High-magnitude and long-duration abstinence reinforcement can promote drug abstinence but can be difficult to finance. Employment may be a vehicle for arranging high-magnitude and long-duration abstinence reinforcement. This study determined if employment-based abstinence reinforcement could increase cocaine abstinence in adults who inject drugs and use cocaine during methadone treatment. Participants could work 4 hr every weekday in a workplace where they could earn about $10.00 per hour in vouchers; they were required to provide routine urine samples. Participants who attended the workplace and provided cocaine-positive urine samples during the initial 4 weeks were invited to work 26 weeks and were randomly assigned to an abstinence-and-work (n = 28) or work-only (n = 28) group. Abstinence-and-work participants had to provide urine samples showing cocaine abstinence to work and maintain maximum pay. Work-only participants could work independent of their urinalysis results. Abstinence-and-work participants provided more (p = .004; OR = 5.80, 95% CI = 2.03–16.56) cocaine-negative urine samples (29%) than did work-only participants (10%). Employment-based abstinence reinforcement can increase cocaine abstinence. PMID:17970256
DeFulio, Anthony; Donlin, Wendy D; Wong, Conrad J; Silverman, Kenneth
2009-09-01
Due to the chronic nature of cocaine dependence, long-term maintenance treatments may be required to sustain abstinence. Abstinence reinforcement is among the most effective means of initiating cocaine abstinence. Practical and effective means of maintaining abstinence reinforcement programs over time are needed. To determine whether employment-based abstinence reinforcement can be an effective long-term maintenance intervention for cocaine dependence. Participants (n = 128) were enrolled in a 6-month job skills training and abstinence initiation program. Participants who initiated abstinence, attended regularly and developed needed job skills during the first 6 months were hired as operators in a data entry business and assigned randomly to an employment-only (control, n = 24) or abstinence-contingent employment (n = 27) group. A non-profit data entry business. Participants Unemployed welfare recipients who used cocaine persistently while enrolled in methadone treatment in Baltimore. Abstinence-contingent employment participants received 1 year of employment-based contingency management, in which access to employment was contingent upon provision of drug-free urine samples under routine and then random drug testing. If a participant provided drug-positive urine or failed to provide a mandatory sample, then that participant received a temporary reduction in pay and could not work until urinalysis confirmed recent abstinence. Cocaine-negative urine samples at monthly assessments across 1 year of employment. During the 1 year of employment, abstinence-contingent employment participants provided significantly more cocaine-negative urine samples than employment-only participants [79.3% and 50.7%, respectively; P = 0.004, odds ratio (OR) = 3.73, 95% confidence interval (CI) = 1.60-8.69]. Conclusions Employment-based abstinence reinforcement that includes random drug testing is effective as a long-term maintenance intervention, and is among the most promising treatments
Nyamathi, Adeline M; Shin, Sanghyuk S; Smeltzer, Jolene; Salem, Benissa E; Yadav, Kartik; Ekstrand, Maria L; Turner, Susan F; Faucette, Mark
Homeless female ex-offenders (homeless female offenders) exiting jail and prison are at a critical juncture during reentry and transitioning into the community setting. The purpose of the study was to compare the effect of a dialectical behavioral therapy-case management (DBT-CM) program with a health promotion (HP) program on achieving drug and alcohol abstinence among female parolees/probationers residing in the community. We conducted a multicenter parallel randomized controlled trial with 130 female parolees/probationers (aged 19-64 years) residing in the community randomly assigned to either DBT-CM (n = 65) or HP (n = 65). The trial was conducted in four community-based partner sites in Los Angeles and Pomona, California, from February 2015 to November 2016. Treatment assignment was carried out using a computer-based urn randomization program. The primary outcome was drug and alcohol use abstinence at 6-month follow up. Analysis was based on data from 116 participants with complete outcome data. Multivariable logistic regression revealed that the DBT-CM program remained an independent positive predictor of decrease in drug use among the DBT-CM participants at 6 months (p = .01) as compared with the HP program participants. Being non-White (p < .05) and having higher depressive symptom scores (p < .05) were associated with lower odds of drug use abstinence (i.e., increased the odds of drug use) at 6 months. DBT-CM increased drug and alcohol abstinence at 6-month follow-up, compared to an HP program.
Holtyn, August F; Koffarnus, Mikhail N; DeFulio, Anthony; Sigurdsson, Sigurdur O; Strain, Eric C; Schwartz, Robert P; Leoutsakos, Jeannie-Marie S; Silverman, Kenneth
2014-11-01
Determine if employment-based reinforcement can increase methadone treatment engagement and drug abstinence in out-of-treatment injection drug users. This study was conducted from 2008 to 2012 in a therapeutic workplace in Baltimore, MD. After a 4-week induction, participants (N=98) could work and earn pay for 26 weeks and were randomly assigned to Work Reinforcement, Methadone & Work Reinforcement, and Abstinence, Methadone & Work Reinforcement conditions. Work Reinforcement participants had to work to earn pay. Methadone & Work Reinforcement and Abstinence, Methadone, & Work Reinforcement participants had to enroll in methadone treatment to work and maximize pay. Abstinence, Methadone, & Work Reinforcement participants had to provide opiate- and cocaine-negative urine samples to maximize pay. Most participants (92%) enrolled in methadone treatment during induction. Drug abstinence increased as a graded function of the addition of the methadone and abstinence contingencies. Abstinence, Methadone & Work Reinforcement participants provided significantly more urine samples negative for opiates (75% versus 54%) and cocaine (57% versus 32%) than Work Reinforcement participants. Methadone & Work Reinforcement participants provided significantly more cocaine-negative samples than Work Reinforcement participants (55% versus 32%). The therapeutic workplace can promote drug abstinence in out-of-treatment injection drug users. Clinical trial registration number: NCT01416584. Copyright © 2014 Elsevier Inc. All rights reserved.
Sigmon, Stacey C; Miller, Mollie E; Meyer, Andrew C; Saulsgiver, Kathryn; Badger, Gary J; Heil, Sarah H; Higgins, Stephen T
2016-05-01
Prior studies by our group demonstrated the efficacy of a brief but intensive behavioral intervention for producing initial smoking abstinence among opioid-dependent patients. In the present study, our aim was to promote longer-duration abstinence in this population. Following an initial 2-week incentive intervention for smoking abstinence, we examined whether a 10-week maintenance arm involving continuation of contingent reinforcement will produce greater smoking abstinence than a similar duration of noncontingent reinforcement. Randomized, 12-week, parallel-group study. Out-patient research clinic in Burlington, Vermont, USA. Opioid-maintained smokers (n = 88) who provided breath carbon monoxide and urinary cotinine specimens and received contingent reinforcement for smoking abstinence during weeks 1-2 (phase 1), with 63 randomized on day 14 to an extended contingent (EC; n = 31) or extended noncontingent (EN; n = 32) experimental condition for weeks 3-12 (phase 2). The EC condition consisted of voucher values that escalated across consecutive negative samples until they reached $30, after which they remained at $30 per negative sample. A positive or a missing sample resulted in no vouchers for that day and reset the value of the next negative same to $9. Two consecutive negatives returned the schedule to the pre-reset value. The EN control condition consisted of vouchers delivered for providing scheduled samples, but independent of smoking status. The primary outcome was percentage of biochemically abstinent samples during phase 2. Secondary measures included abstinence status at final study visit, complete abstinence, participants' longest duration of continuous abstinence, cotinine and carbon monoxide (CO) levels and self-reported cigarettes per day. EC participants achieved greater smoking abstinence during phase 2 than EN participants [46.7 versus 23.5% negative samples, respectively; odds ratio (OR) = 2.98, 95% confidence interval (CI) = 1.16-7.65, χ(2
ERIC Educational Resources Information Center
Silverman, Kenneth; Robles, Elias; Mudric, Timothy; Bigelow, George E.; Stitzer, Maxine L.
2004-01-01
This study determined whether long-term abstinence reinforcement could maintain cocaine abstinence throughout a yearlong period. Patients who injected drugs and used cocaine during methadone treatment (n = 78) were randomly assigned to 1 of 2 abstinence-reinforcement groups or to a usual care control group. Participants in the 2…
ERIC Educational Resources Information Center
Ghitza, Udi E.; Epstein, David H.; Schmittner, John; Vahabzadeh, Massoud; Lin, Jia-Ling; Preston, Kenzie L.
2007-01-01
To examine the effect of reinforcer density in prize-based abstinence reinforcement, heroin/cocaine users (N = 116) in methadone maintenance (100 mg/day) were randomly assigned to a noncontingent control group (NonC) or to 1 of 3 groups that earned prize draws for abstinence: manual drawing with standard prize density (MS) or computerized drawing…
Ybarra, Michele L.; Bull, Sheana S.; Prescott, Tonya L.; Korchmaros, Josephine D.; Bangsberg, David R.; Kiwanuka, Julius P.
2013-01-01
Context Cost-effective, scalable programs are urgently needed in countries deeply affected by HIV. Methods This parallel-group RCT was conducted in four secondary schools in Mbarara, Uganda. Participants were 12 years and older, reported past-year computer or Internet use, and provided informed caregiver permission and youth assent. The intervention, CyberSenga, was a five-hour online healthy sexuality program. Half of the intervention group was further randomized to receive a booster at four-months post-intervention. The control arm received ‘treatment as usual’ (i.e., school-delivered sexuality programming). The main outcome measures were: 1) condom use and 2) abstinence in the past three months at six-months' post-intervention. Secondary outcomes were: 1) condom use and 2) abstinence at three-month's post-intervention; and 6-month outcomes by booster exposure. Analyses were intention to treat. Results All 416 eligible youth were invited to participate, 88% (n = 366) of whom enrolled. Participants were randomized to the intervention (n = 183) or control (n = 183) arm; 91 intervention participants were further randomized to the booster. No statistically significant results were noted among the main outcomes. Among the secondary outcomes: At three-month follow-up, trends suggested that intervention participants (81%) were more likely to be abstinent than control participants (74%; p = 0.08), and this was particularly true among youth who were abstinent at baseline (88% vs. 77%; p = 0.02). At six-month follow-up, those in the booster group (80%) reported higher rates of abstinence than youth in the intervention, no booster (57%) and control (55%) groups (p = 0.15); they also reported lower rates of unprotected sex (5%) compared to youth in the intervention, no booster (24%) and control (21%) groups (p = 0.21) among youth sexually active at baseline. Conclusions The CyberSenga program may affect HIV preventive behavior among abstinent
Scheuermann, Taneisha S; Richter, Kimber P; Rigotti, Nancy A; Cummins, Sharon E; Harrington, Kathleen F; Sherman, Scott E; Zhu, Shu-Hong; Tindle, Hilary A; Preacher, Kristopher J
2017-12-01
To estimate the prevalence and predictors of failed biochemical verification of self-reported abstinence among participants enrolled in trials of hospital-initiated smoking cessation interventions. Comparison of characteristics between participants who verified and those who failed to verify self-reported abstinence. Multi-site randomized clinical trials conducted between 2010 and 2014 in hospitals throughout the United States. Recently hospitalized smokers who reported tobacco abstinence 6 months post-randomization and provided a saliva sample for verification purposes (n = 822). Outcomes were salivary cotinine-verified smoking abstinence at 10 and 15 ng/ml cut-points. Predictors and correlates included participant demographics and tobacco use; hospital diagnoses and treatment; and study characteristics collected via surveys and electronic medical records. Usable samples were returned by 69.8% of the 1178 eligible trial participants who reported 7-day point prevalence abstinence. The proportion of participants verified as quit was 57.8% [95% confidence interval (CI) = 54.4, 61.2; 10 ng/ml cut-off] or 60.6% (95% CI = 57.2, 63.9; 15 ng/ml). Factors associated independently with verification at 10 ng/ml were education beyond high school education [odds ratio (OR) = 1.51; 95% CI = 1.07, 2.11], continuous abstinence since hospitalization (OR = 2.82; 95% CI = 2.02, 3.94), mailed versus in-person sample (OR = 3.20; 95% CI = 1.96, 5.21) and race. African American participants were less likely to verify abstinence than white participants (OR = 0.64; 95% CI = 0.44, 0.93). Findings were similar for verification at 15 ng/ml. Verification rates did not differ by treatment group. In the United States, high rates (40%) of recently hospitalized smokers enrolled in smoking cessation trials fail biochemical verification of their self-reported abstinence. © 2017 Society for the Study of Addiction.
Bengtson, J.E.; Wang, Q.; Luo, X.; Marigi, Erick; Winta, Ghidei; Ahluwalia, J.S.
2015-01-01
Objective To examine baseline characteristics and biochemically verified 1-, 4-, and 6-month tobacco quit rates among college students enrolled in a Quit and Win cessation trial, comparing those who concurrently smoke both hookah and cigarettes with those who deny hookah use. Methods Analyses were conducted on data from 1,217 college students enrolled in a Quit and Win tobacco cessation randomized clinical trial from 2010–2012. Multivariable logistic regression (MLR) analyses examined group differences in baseline characteristics and cotinine verified 30-day abstinence at 1, 4, and 6-month follow-up, adjusting for baseline covariates. Results Participants smoked 11.5(±8.1) cigarettes per day on 28.5(±3.8) days/month, and 22% smoked hookah in the past 30 days. Hookah smokers (n=270) were more likely to be male (p<0.0001), younger (p<0.0001), report more binge drinking (p<0.0001) and score higher on impulsivity (p<0.001). MLR results indicate that hookah users, when compared to non-users, had a 36% decrease in odds of self-reported 30-day abstinence at 4-months (OR= 0.64, 95% CI=0.45–0.93, p=0.02) and a 63% decrease in odds in biochemically verified continuous abstinence at 6-months (OR = 0.37, CI=0.14–0.99, p=0.05). Conclusion College cigarette smokers who concurrently use hookah display several health risk factors and demonstrate lower short and long-term tobacco abstinence rates. PMID:25773472
Thorndike, Anne N; Achtyes, Eric D; Cather, Corinne; Pratt, Sarah; Pachas, Gladys N; Hoeppner, Susanne S; Evins, A Eden
2016-03-01
People with serious mental illness die earlier than those without mental illness, largely from cardiovascular disease due to high rates of smoking and obesity. The objective of this study was to determine whether the metabolic effects of postcessation weight gain among smokers with serious mental illness attenuated the cardiovascular benefit of tobacco abstinence. A subgroup analysis was conducted of 65 outpatient smokers with DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder from 10 community mental health centers in 6 states who enrolled between March 2008-April 2012 and completed a trial of varenicline for tobacco abstinence. The intervention included a 12-week open-label phase with varenicline followed by a 40-week randomized, placebo-controlled phase in 87 participants who achieved 12-week abstinence. Main outcome measures were smoking status and change from baseline in weight and 10-year Framingham cardiovascular risk score at end of intervention (week 52). At week 52, 65 participants completed follow-up (33 abstinent; 32 relapsed). At baseline, the 2 groups did not differ in body mass index (mean = 31 kg/m(2)), blood pressure, serum glucose, or diagnoses of diabetes (31%) and hypertension (34%). Abstinent participants were older and had a higher mean baseline Framingham risk score (14.2% vs 10.3%, P = .002). At week 52, abstinent participants gained more weight than relapsed participants (4.8 vs 1.2 kg, P = .048) and, as a result of quitting smoking, had a greater reduction in Framingham risk score (-7.6% vs 0.0%, P < .001). There was no effect of study drug assignment on weight or Framingham risk score. Sustained tobacco abstinence reduced 10-year cardiovascular risk in outpatients with serious mental illness despite significant postcessation weight gain and high prevalence of obesity, diabetes, and hypertension. Clinicaltrials.gov identifier: NCT00621777. © Copyright 2016 Physicians Postgraduate Press, Inc.
A Randomized Trial of Employment-Based Reinforcement of Cocaine Abstinence in Injection Drug Users
ERIC Educational Resources Information Center
Silverman, Kenneth; Wong, Conrad J.; Needham, Mick; Diemer, Karly N.; Knealing, Todd; Crone-Todd, Darlene; Fingerhood, Michael; Nuzzo, Paul; Kolodner, Kenneth
2007-01-01
High-magnitude and long-duration abstinence reinforcement can promote drug abstinence but can be difficult to finance. Employment may be a vehicle for arranging high-magnitude and long-duration abstinence reinforcement. This study determined if employment-based abstinence reinforcement could increase cocaine abstinence in adults who inject drugs…
Rosenthal, Richard N; Lofwall, Michelle R; Kim, Sonnie; Chen, Michael; Beebe, Katherine L; Vocci, Frank J
2016-07-19
The effectiveness of buprenorphine treatment of opioid dependence is limited by suboptimal medication adherence, abuse, and diversion. To determine whether 6-month buprenorphine implants are noninferior to daily sublingual buprenorphine as maintenance treatment for opioid-dependent patients with stable abstinence. Outpatient, randomized, active-controlled, 24-week, double-blind, double-dummy study conducted at 21 US sites from June 26, 2014, through May 18, 2015. Outpatients were prescribed daily sublingual buprenorphine for 6 months or more, were abstinent while taking 8 mg/d or less of sublingual buprenorphine for 90 days or longer, and were determined to be clinically stable by their physician. Participants were randomized to receive sublingual buprenorphine plus 4 placebo implants or sublingual placebo plus four 80-mg buprenorphine hydrochloride implants (expected efficacy, 24 weeks). The primary end point was between-group difference in proportion of responders (≥4 of 6 months without opioid-positive urine test result [monthly and 4 times randomly] and self-report). The noninferiority established for the lower bound of the 95% confidence interval was greater than -0.20 (P < .025). Secondary end points included cumulative percentage of negative opioid urine results, abstinence, and time to first illicit opioid use. Safety was assessed by adverse event reporting. Of 177 participants (mean age, 39 years; 40.9% female), 90 were randomized to sublingual buprenorphine with placebo implants and 87 to buprenorphine implants with sublingual placebo; 165 of 177 (93.2%) completed the trial. Eighty-one of 84 (96.4%) receiving buprenorphine implants and 78 of 89 (87.6%) receiving sublingual buprenorphine were responders, an 8.8% difference (1-sided 97.5% CI, 0.009 to ∞; P < .001 for noninferiority). Over 6 months, 72 of 84 (85.7%) receiving buprenorphine implants and 64 of 89 (71.9%) receiving sublingual buprenorphine maintained opioid abstinence (hazard ratio
Alessi, Sheila M; Rash, Carla J; Petry, Nancy M
2017-03-01
Abstinence reinforcement is efficacious for improving smoking treatment outcomes, but practical constraints related to the need for multiple in-person carbon monoxide (CO) breath tests daily to verify smoking abstinence have limited its use. This study tested an mHealth procedure to remotely monitor and reinforce smoking abstinence in individuals' natural environment. Eligible treatment-seeking smokers (N = 90) were randomized to (1) usual care and ecological monitoring with abstinence reinforcement (mHealth reinforcement) or (2) without reinforcement (mHealth monitoring). Usual care was 8 weeks of transdermal nicotine and twice-weekly telephone counseling. Following training, an interactive voice response system prompted participants to conduct CO tests 1-3 daily at pseudorandom times (7 am to 10 pm) for 4 weeks. When prompted, participants used a study cell phone and CO monitor to complete a CO self-test, video record the process, and submit videos using multimedia messaging. mHealth reinforcement participants could earn prizes for smoking-negative on-time CO tests. The interactive voice response generated preliminary earnings immediately. Earnings were finalized by comparing video records against participants' self-reports. mHealth reinforcement was associated with a greater proportion of smoking-negative CO tests, longest duration of prolonged abstinence, and point-prevalence abstinence during the monitoring/reinforcement phase compared to mHealth monitoring (p < .01, d = 0.8-1.3). Follow-up (weeks 4-24) analyses indicated main effects of reinforcement on point-prevalence abstinence and proportion of days smoked (p ≤ .05); values were comparable by week 24. mHealth reinforcement has short-term efficacy. Research on methods to enhance and sustain benefits is needed. This study suggests that mHealth abstinence reinforcement is efficacious and may present temporal and spatial opportunities to research, engage, and support smokers trying to quit that do not exist
Treatment Satisfaction in a Randomized Clinical Trial of mHealth Smoking Abstinence Reinforcement.
Alessi, Sheila M; Rash, Carla J
2017-01-01
The importance of patient satisfaction in modern healthcare is widely recognized, but research on satisfaction in the context of smoking cessation has not kept pace. The purpose of this study was to explore treatment satisfaction in a sample of smokers (N=84) randomized to one of two smoking cessation treatment interventions (mHealth reinforcement and mHealth monitoring) that used cell phone-based procedures to monitor smoking status in individuals' natural environments for 4 weeks. Starting on the target quit date, participants received usual care smoking cessation treatment consisting of 8 weeks of transdermal nicotine and 4 weeks of twice-weekly telephone counseling were also prompted 1 to 3 times daily (with exact number and timing not disclosed beforehand) to use a study cell phone and CO monitor to complete a CO self-test, video-record the process, and submit videos using multimedia messaging within 2 hours. mHealth reinforcement participants could earn prizes for smoking-negative on-time CO tests. A treatment satisfaction survey was completed at the end of the 4-week monitoring/reinforcement phase. Results indicate that participants overwhelmingly endorsed high levels of overall satisfaction in both conditions. Treatment adherence did not differ between conditions, but was positively associated with endorsing the highest satisfaction with help quitting with the intervention (p<.01 to .03). mHealth reinforcement was associated with increased longest duration of abstinence (p<.01). Controlling for relevant participant characteristics and treatment adherence, longest duration of abstinence robustly predicted highest satisfaction with help quitting and mediated the effect of treatment condition on that satisfaction. Further research on treatment satisfaction may aid the development of effective abstinence reinforcement and other smoking cessation interventions. Copyright © 2016 Elsevier Inc. All rights reserved.
Holtyn, August F.; Koffarnus, Mikhail N.; DeFulio, Anthony; Sigurdsson, Sigurdur O.; Strain, Eric C.; Schwartz, Robert P.; Leoutsakos, Jeannie-Marie S.; Silverman, Kenneth
2014-01-01
Objective Determine if employment-based reinforcement can increase methadone treatment engagement and drug abstinence in out-of-treatment injection drug users. Method This study was conducted from 2008–2012 in a therapeutic workplace in Baltimore, MD. After a 4-week induction, participants (N=98) could work and earn pay for 26 weeks and were randomly assigned to Work Reinforcement, Methadone & Work Reinforcement, and Abstinence, Methadone & Work Reinforcement conditions. Work Reinforcement participants had to work to earn pay. Methadone & Work Reinforcement, and Abstinence, Methadone, & Work Reinforcement participants had to enroll in methadone treatment to work and maximize pay. Abstinence, Methadone, & Work Reinforcement participants had to provide opiate- and cocaine-negative urine samples to maximize pay. Results Most participants (92%) enrolled in methadone treatment during induction. Drug abstinence increased as a graded function of the addition of the methadone and abstinence contingencies. Abstinence, Methadone & Work Reinforcement participants provided significantly more urine samples negative for opiates (75% versus 54%) and cocaine (57% versus 32%) than Work Reinforcement participants. Methadone & Work Reinforcement participants provided significantly more cocaine-negative samples than Work Reinforcement participants (55% versus 32%). Conclusion The therapeutic workplace can promote drug abstinence in out-of-treatment injection drug users. PMID:24607365
de Dios, Marcel A.; Anderson, Bradley J.; Stanton, Cassandra; Audet, Daniel A.; Stein, Michael
2012-01-01
Light smoking is particularly prevalent among Latino smokers. Nicotine replacement (NRT) and varenicline are effective medications for smoking cessation for moderate-heavy smokers, but have not been tested in light smokers and thus there are no treatment guidelines for use with light smokers. This pilot trial tested the efficacy of NRT and varenicline in increasing smoking abstinence among Latino light smokers. A 3-group (NRT, varenicline, varenicline-placebo) randomized design was used and Latino light smokers (≤10 cpd) received 12 weeks of treatment which included a culturally-informed behavioral health session and ongoing medication management visits. At follow-up, there were no abstinent participants in the placebo and NRT groups. However, 30% of participants in the varenicline group were abstinent at the 3, 4, and 6 month follow-up. This study represents the only investigation that specifically targets Latino light smokers using these treatments and characterizing their treatment adherence. PMID:22377389
Kaper, J; Wagena, E J; Willemsen, M C; van Schayck, C P
2006-11-01
We studied whether reimbursement for smoking cessation treatment (SCT) can increase prolonged abstinence from smoking up to 2 years. SETTING, PARTICIPANTS AND DESIGN: From the general population, we recruited smokers and assigned them randomly to a control group (n = 634) or an intervention group (n = 632). For 6 months, participants in the intervention group could apply for reimbursement and received information regarding the reimbursed SCT. Participants in the control group received no reimbursement or information. In this follow-up study, prolonged abstinence from smoking was defined as reported being abstinent from at least 7 days before the end of reimbursement until the follow-up assessment 6 months or 2 years later. At 6 months after the end of reimbursement, 18 participants in the control group (2.8%) and 35 participants (5.5%) in the intervention group reported sustained abstinence for at least 6 months [odds ratio (OR) = 2.0, 95% confidence interval (CI) 1.1-3.6]. Two years after the reimbursement period, 10 participants in the control group (1.6%) and 27 participants in the intervention group (4.3%) still reported sustained abstinence (OR = 4.1, 95% CI 1.7-10.2). The overall effectiveness of SCT increased with reimbursement and was 22% in the intervention group and 8% in the control group after 2 years. Reimbursement may be an effective strategy to increase the prolonged abstinence rate even after 2 years.
Susukida, Ryoko; Crum, Rosa M; Ebnesajjad, Cyrus; Stuart, Elizabeth A; Mojtabai, Ramin
2017-07-01
To compare randomized controlled trial (RCT) sample treatment effects with the population effects of substance use disorder (SUD) treatment. Statistical weighting was used to re-compute the effects from 10 RCTs such that the participants in the trials had characteristics that resembled those of patients in the target populations. Multi-site RCTs and usual SUD treatment settings in the United States. A total of 3592 patients in 10 RCTs and 1 602 226 patients from usual SUD treatment settings between 2001 and 2009. Three outcomes of SUD treatment were examined: retention, urine toxicology and abstinence. We weighted the RCT sample treatment effects using propensity scores representing the conditional probability of participating in RCTs. Weighting the samples changed the significance of estimated sample treatment effects. Most commonly, positive effects of trials became statistically non-significant after weighting (three trials for retention and urine toxicology and one trial for abstinence); also, non-significant effects became significantly positive (one trial for abstinence) and significantly negative effects became non-significant (two trials for abstinence). There was suggestive evidence of treatment effect heterogeneity in subgroups that are under- or over-represented in the trials, some of which were consistent with the differences in average treatment effects between weighted and unweighted results. The findings of randomized controlled trials (RCTs) for substance use disorder treatment do not appear to be directly generalizable to target populations when the RCT samples do not reflect adequately the target populations and there is treatment effect heterogeneity across patient subgroups. © 2017 Society for the Study of Addiction.
Linardon, Jake; Wade, Tracey D
2018-04-01
It is unclear how many patients with bulimia nervosa (BN) completely abstain from the core behavioral symptoms after receiving psychological treatment. The present meta-analysis of randomized controlled trials (RCTs) aimed to (a) estimate the prevalence of patients who abstain from binge eating and/or purging following all psychological treatments for BN, and (b) test whether these abstinence estimates are moderated by the type of treatment modality delivered, the definition of abstinence applied, and trial quality. Forty-five RCTs were included, with 78 psychotherapy conditions. Pooled event rates were calculated using random effects models. At post-treatment, the total weighted percentage of treatment-completers who achieved abstinence was 35.4% (95% CI = 29.6, 41.7), while the total weighted percentage of abstinence for all randomized patients (intention-to-treat) was 29.9% (95% CI = 25.7, 33.2). Abstinence estimates were highest in trials that used behavioral-based treatments (e.g., cognitive-behavioral therapy, behavior therapy). There was also evidence that guided self-help interventions produced the lowest post-treatment abstinence rates, but with no difference at follow-up from clinician-led treatments, and studies that used a shorter timeframe for defining abstinence (i.e., 14 days symptom-free compared to 28-days symptom-free) produced the highest abstinence rates. Abstinence estimates at follow-up for both the completer (34.6%; 95% CI = 29.3, 40.2) and intention-to-treat (28.6%; 95% CI = 25.1, 32.3) analyses were essentially the same as the post-treatment estimates. Over 60% of patients fail to fully abstain from core BN symptoms even after receiving our most empirically-supported treatments. The present findings highlight the urgency toward improving the effectiveness of psychological treatments for BN. © 2018 Wiley Periodicals, Inc.
Surran, B; Visintainer, P; Chamberlain, S; Kopcza, K; Shah, B; Singh, R
2013-12-01
To compare the efficacy of clonidine versus phenobarbital in reducing morphine sulfate treatment days for neonatal abstinence syndrome (NAS). Prospective, non-blinded, block randomized trial at a single level III NICU (Neonatal Intensive Care Unit). Eligible infants were treated with a combination of medications as per protocol. Primary outcome was treatment days with morphine sulfate. Secondary outcomes were the mean total morphine sulfate dose, outpatient phenobarbital days, adverse events and treatment failures. A total of 82 infants were eligible, of which 68 were randomized with 34 infants in each study group. Adjusting for covariates phenobarbital as compared with clonidine had shorter morphine sulfate treatment days (-4.6, 95% confidence interval (CI): -0.3, -8.9; P=0.037) with no difference in average morphine sulfate total dose (1.1 mg kg(-1), 95% CI: -0.1, 2.4; P=0.069). Post-discharge phenobarbital was continued for an average of 3.8 months (range 1 to 8 months). No other significant differences were noted. Phenobarbital as adjunct had clinically nonsignificant shorter inpatient but significant overall longer therapy time as compared with clonidine.
Efficacy of abstinence promotion media messages: findings from an online randomized trial.
Evans, W Douglas; Davis, Kevin C; Ashley, Olivia Silber; Blitstein, Jonathan; Koo, Helen; Zhang, Yun
2009-10-01
We conducted an online randomized experiment to evaluate the efficacy of messages from the Parents Speak Up National Campaign (PSUNC) to promote parent-child communication about sex. We randomly assigned a national sample of 1,969 mothers and fathers to treatment (PSUNC exposure) and control (no exposure) conditions. Mothers were further randomized into treatment and booster (additional messages) conditions to evaluate dose-response effects. Participants were surveyed at baseline, 4 weeks postexposure, and 6 months postexposure. We used multivariable logistic regression procedures in our analysis. Treatment fathers were more likely than control fathers to initiate conversations about sex at 4 weeks, and treatment fathers and mothers were more likely than controls at 6 months to recommend that their children wait to have sex. Treatment fathers and mothers were far more likely than controls to use the campaign Web site. There was a dose-response effect for mothers' Web site use. Using new media methods, this study shows that PSUNC messages are efficacious in promoting parent-child communication about sex and abstinence. Future research should evaluate mechanisms and effectiveness in natural settings.
Vuchinich, Rudy; Wallace, Dennis; Milby, Jesse B; Schumacher, Joseph E; Mennemeyer, Stephen; Kertesz, Stefan
2009-06-01
Clinical trials with cocaine-dependent outpatients have found a strong relation between in-treatment and follow-up abstinence, and the strength of this relation is constant across treatment conditions with variable efficacy in generating abstinence. The authors conducted secondary analyses of data from 3 clinical trials to determine whether this relation generalizes to cocaine-dependent homeless persons. The 3 trials (total N = 543) were conducted in a community health care facility for homeless people. The 7 treatment arms across the 3 trials were combinations of day treatment, abstinence-contingent housing, and vocational training. Drug use was measured with urine toxicology testing. Consecutive weeks of abstinence during treatment were strongly related to abstinence at the 12-month follow-up, whether or not missing 12-month data were included in the analysis. The treatment arms differed in their efficacy in generating abstinence, but the relation between in-treatment and follow-up abstinence did not differ across treatment arms. These results replicate earlier reports of these relations and extend them to a population of homeless people. The lack of differences between treatment arms in the in-treatment-follow-up abstinence relation implies that that relation is independent of the treatment-specific intervention components that generate group differences in abstinence.
Carrieri, Patrizia Maria; Michel, Laurent; Lions, Caroline; Cohen, Julien; Vray, Muriel; Mora, Marion; Marcellin, Fabienne; Spire, Bruno; Morel, Alain; Roux, Perrine
2014-01-01
Methadone coverage is poor in many countries due in part to methadone induction being possible only in specialized care (SC). This multicenter pragmatic trial compared the effectiveness of methadone treatment between two induction models: primary care (PC) and SC. In this study, registered at ClinicalTrials.Gov (NCT00657397), opioid-dependent individuals not on methadone treatment for at least one month or receiving buprenorphine but needing to switch were randomly assigned to start methadone in PC (N = 155) or in SC (N = 66) in 10 sites in France. Visits were scheduled at months M0, M3, M6 and M12. The primary outcome was self-reported abstinence from street-opioids at 12 months (M12) (with an underlying 15% non-inferiority hypothesis for PC). Secondary outcomes were abstinence during follow-up, engagement in treatment (i.e. completing the induction period), retention and satisfaction with the explanations provided by the physician. Primary analysis used intention to treat (ITT). Mixed models and the log-rank test were used to assess the arm effect (PC vs. SC) on the course of abstinence and retention, respectively. In the ITT analysis (n = 155 in PC, 66 in SC), which compared the proportions of street-opioid abstinent participants, 85/155 (55%) and 22/66 (33%) of the participants were classified as street-opioid abstinent at M12 in PC and SC, respectively. This ITT analysis showed the non-inferiority of PC (21.5 [7.7; 35.3]). Engagement in treatment and satisfaction with the explanations provided by the physician were significantly higher in PC than SC. Retention in methadone and abstinence during follow-up were comparable in both arms (p = 0.47, p = 0.39, respectively). Under appropriate conditions, methadone induction in primary care is feasible and acceptable to both physicians and patients. It is as effective as induction in specialized care in reducing street-opioid use and ensuring engagement and retention in treatment for opioid dependence. Number Eudract
Positive Psychotherapy for Smoking Cessation: A Pilot Randomized Controlled Trial.
Kahler, Christopher W; Spillane, Nichea S; Day, Anne M; Cioe, Patricia A; Parks, Acacia; Leventhal, Adam M; Brown, Richard A
2015-11-01
Greater depressive symptoms and low positive affect (PA) are associated with poor smoking cessation outcomes. Smoking cessation approaches that incorporate a focus on PA may benefit smokers trying to quit. The purpose of this study was to conduct a pilot randomized clinical trial to compare standard smoking cessation treatment (ST) with smoking cessation treatment that targets positive affect, termed positive psychotherapy for smoking cessation (PPT-S). Smokers who were seeking smoking cessation treatment were assigned by urn randomization to receive, along with 8 weeks of nicotine replacement therapy, either ST (n = 31) or PPT-S (n = 35). Seven-day point prevalence smoking abstinence was biochemically confirmed at 8, 16, and 26 weeks. Compared to ST, a greater percentage of participants in PPT-S were abstinent at 8 weeks, 16 weeks, and 26 weeks, but these differences were nonsignificant. In a more statistically powerful longitudinal model, participants in PPT-S had a significantly higher odds of abstinence (adjusted odds ratio [AOR] = 2.75; 95% CI = 1.02, 7.42; p = .046) across follow-ups compared to those in ST. The positive effect of PPT-S was stronger for those higher in PA (OR = 6.69, 95% CI = 1.16, 38.47, p = .03). Greater use of PPT-S strategies during the initial 8 weeks of quitting was associated with a less steep decline in smoking abstinence rates over time (OR = 2.64, 95% CI = 1.06, 6.56, p =.04). This trial suggests substantial promise for incorporating PPT into smoking cessation treatment. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
Garcia-Rodriguez, Olaya; Secades-Villa, Roberto; Higgins, Stephen T; Fernandez-Hermida, Jose R; Carballo, Jose L; Errasti Perez, Jose M; Al-halabi Diaz, Susana
2009-06-01
The aims of this study were to assess whether voucher magnitude improved cocaine abstinence and retention in an outpatient treatment for cocaine dependence, and to determine the effectiveness of a contingency management intervention in a European cultural context. A randomized controlled trial was conducted in which 96 participants who were randomly assigned to 1 of 3 treatment conditions in a community setting: standard outpatient treatment, community reinforcement approach (CRA) plus low monetary value vouchers (each point earned was equivalent to 0.125 Euro, US$ 0.18), and CRA plus high monetary value vouchers (each point was worth 0.25 Euro, US$ 0.36). In the standard treatment group, mean percentage of cocaine-negative samples was 88.45%, versus 96.09% in the CRA plus low-vouchers group, and 97.07% in the CRA plus high-vouchers group. Retention rate at 6 months was 36.5% in the standard treatment group, 53.3% in the CRA plus low-vouchers group, and 69.0% in the CRA plus high-vouchers group. The CRA plus vouchers groups obtained better results than the standard program. This study showed that treating cocaine addiction by combining CRA with vouchers was more effective than standard treatment in community outpatient programs in Spain.
Snus undermines quit attempts but not abstinence: a randomised clinical trial among US smokers.
Carpenter, Matthew J; Wahlquist, Amy E; Burris, Jessica L; Gray, Kevin M; Garrett-Mayer, Elizabeth; Cummings, K Michael; Alberg, Anthony J
2017-03-01
Observational studies and a few clinical trials suggest that use of low nitrosamine smokeless tobacco (snus) can facilitate smoking cessation. To better understand the real-world impact of snus on smoking behaviour, a large-scale, long-term clinical trial of naturalistic snus use among smokers is needed. A nationwide clinical trial compared abstinence outcomes among smokers who were randomised to receive free samples of snus versus not. Participants (N=1236) were recruited throughout the US and assessed for 1 year following a 6-week naturalistic sampling period, with high retention throughout. Primary outcomes included self-reported quit attempts, floating abstinence (any 7-day period of non-smoking) and 7-day point-prevalence abstinence at 6 months and 12 months. Secondary outcomes were changes in smoking, motivation and confidence to quit and adverse events. No tobacco industry support was provided. Within snus group, 82% used at least once, and 16% were using regularly at end of sampling period. Compared to control participants, smokers in the snus group were less likely to make any quit attempt (RR=0.83; 95% CI 0.70 to 1.00), and any 24 h quit attempt (RR=0.77; 95% CI 0.63 to 0.95). There were no group differences on any measure of abstinence. Provision of snus in a naturalistic context resulted in minimal uptake, and as a whole, undermined quit attempts and did not increase smoking abstinence. Results do not support the unguided, free provision of snus among smokers not motivated to quit as a means to facilitate quit attempts. NCT01509586, Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Lorcaserin for Smoking Cessation and Associated Weight Gain: A Randomized 12-Week Clinical Trial.
Shanahan, William R; Rose, Jed E; Glicklich, Alan; Stubbe, Scott; Sanchez-Kam, Matilde
2017-08-01
Lorcaserin is a selective serotonin 2C receptor agonist approved by the Food and Drug Administration for chronic weight management. Preclinical data suggest that it may also be effective in smoking cessation through modulation of the dopaminergic reward system. This was a 12-week, randomized, double-blind, placebo-controlled trial conducted in 30 centers in the United States. Six hundred three adult smokers with a Body Mass Index of 18.5-35 kg/m2, averaging at least 10 cigarettes/day with no period of abstinence >3 months for the past year were randomized to lorcaserin 10 mg once daily (QD), 10 mg twice daily (BID) or placebo; all received standardized smoking cessation counseling weekly. The target quit date was day 15. The primary endpoint was the exhaled carbon monoxide confirmed Continuous Abstinence Rate for weeks 9-12 (month 3). Continuous Abstinence Rates for month 3 were 5.6%, 8.7%, and 15.3% for the placebo, QD and BID groups, respectively (BID vs. placebo odds ratio 3.02, 95% confidence interval 1.47, 6.22, p = .0027. Change in weight at week 12 (randomized population) was -0.01, -0.35 and -0.98 kg, respectively (p = .0004, BID vs. placebo), and +0.73, +0.76, and -0.41 kg in participants achieving month 3 continuous abstinence. The most frequent adverse events were headache, nausea, constipation, and fatigue. Lorcaserin with counseling was associated with dose-related increases in smoking cessation and prevention of associated weight gain over a 3-month period. Further investigation of lorcaserin in smoking cessation is warranted. Trial Registration: ClinicalTrials.gov. Identifier: NCT02044874. This randomized, controlled trial demonstrated that lorcaserin used in conjunction with standard cessation counseling was associated with dose-related increases in smoking cessation and prevention of associated weight gain. To our knowledge, this is the first demonstration in humans of a potential role of 5-HT2C agonism in the modulation of central neurological
A Randomized Trial of Individual and Couple Behavioral Alcohol Treatment for Women
ERIC Educational Resources Information Center
Mccrady, Barbara S.; Epstein, Elizabeth E.; Cook, Sharon; Jensen, Noelle; Hildebrandt, Thomas
2009-01-01
Although alcohol use disorders (AUDs) adversely affect women, research on efficacious treatments for women is limited. In this randomized efficacy trial of 102 heterosexual women with AUDs, the authors compared alcohol behavioral couple therapy (ABCT) and alcohol behavioral individual therapy (ABIT) on percentage of days abstinent (PDA) and…
Extended treatment for cigarette smoking cessation: a randomized control trial.
Laude, Jennifer R; Bailey, Steffani R; Crew, Erin; Varady, Ann; Lembke, Anna; McFall, Danielle; Jeon, Anna; Killen, Diana; Killen, Joel D; David, Sean P
2017-08-01
To test the potential benefit of extending cognitive-behavioral therapy (CBT) relative to not extending CBT on long-term abstinence from smoking. Two-group parallel randomized controlled trial. Patients were randomized to receive non-extended CBT (n = 111) or extended CBT (n = 112) following a 26-week open-label treatment. Community clinic in the United States. A total of 219 smokers (mean age: 43 years; mean cigarettes/day: 18). All participants received 10 weeks of combined CBT + bupropion sustained release (bupropion SR) + nicotine patch and were continued on CBT and either no medications if abstinent, continued bupropion + nicotine replacement therapy (NRT) if increased craving or depression scores, or varenicline if still smoking at 10 weeks. Half the participants were randomized at 26 weeks to extended CBT (E-CBT) to week 48 and half to non-extended CBT (no additional CBT sessions). The primary outcome was expired CO-confirmed, 7-day point-prevalence (PP) at 52- and 104-week follow-up. Analyses were based on intention-to-treat. PP abstinence rates at the 52-week follow-up were comparable across non-extended CBT (40%) and E-CBT (39%) groups [odds ratio (OR) = 0.99; 95% confidence interval (CI) = 0.55, 1.78]. A similar pattern was observed across non-extended CBT (39%) and E-CBT (33%) groups at the 104-week follow-up (OR = 0.79; 95% CI= 0.44, 1.40). Prolonging cognitive-behavioral therapy from 26 to 48 weeks does not appear to improve long-term abstinence from smoking. © 2017 Society for the Study of Addiction.
A randomized controlled trial of a money management-based substance use intervention.
Rosen, Marc I; Carroll, Kathleen M; Stefanovics, Elina; Rosenheck, Robert A
2009-04-01
Money management has been implemented, often in bundled interventions, as a strategy to counteract spending of public support checks and other funds on drugs and alcohol. The authors conducted a randomized controlled trial of a voluntary money management program as an adjunctive treatment for patients in treatment for mental illness, substance use disorders, or both. In the advisor-teller money manager (ATM) intervention, a money manager stores patients' checkbooks and automated bank cards, trains patients to manage their own funds, and links spending to activities related to their treatment goals. Eighty-five veterans with recent use of alcohol or cocaine were randomly assigned to 36 weeks of the ATM intervention or a control intervention (completion of a simple financial workbook). With ATM, 75% of veterans gave their checkbook to their money manager to hold, and participants attended significantly more therapy sessions than those assigned to the control therapy (mean of 20.6 versus 8.1 sessions). Although participants assigned to ATM did not show significantly greater improvement over time on the primary outcomes (self-reported abstinence from alcohol and cocaine and negative urine tests for cocaine metabolite), they reduced their Addiction Severity Index drug and alcohol use composite scale scores more rapidly than the control group. High rates of abstinence in both groups created a ceiling effect, limiting the power to detect improved abstinence rates. In this relatively small trial, ATM, a money management intervention, showed promise in engaging patients, improving their money management, and improving some substance abuse outcomes.
A general method for handling missing binary outcome data in randomized controlled trials.
Jackson, Dan; White, Ian R; Mason, Dan; Sutton, Stephen
2014-12-01
The analysis of randomized controlled trials with incomplete binary outcome data is challenging. We develop a general method for exploring the impact of missing data in such trials, with a focus on abstinence outcomes. We propose a sensitivity analysis where standard analyses, which could include 'missing = smoking' and 'last observation carried forward', are embedded in a wider class of models. We apply our general method to data from two smoking cessation trials. A total of 489 and 1758 participants from two smoking cessation trials. The abstinence outcomes were obtained using telephone interviews. The estimated intervention effects from both trials depend on the sensitivity parameters used. The findings differ considerably in magnitude and statistical significance under quite extreme assumptions about the missing data, but are reasonably consistent under more moderate assumptions. A new method for undertaking sensitivity analyses when handling missing data in trials with binary outcomes allows a wide range of assumptions about the missing data to be assessed. In two smoking cessation trials the results were insensitive to all but extreme assumptions. © 2014 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.
A general method for handling missing binary outcome data in randomized controlled trials
Jackson, Dan; White, Ian R; Mason, Dan; Sutton, Stephen
2014-01-01
Aims The analysis of randomized controlled trials with incomplete binary outcome data is challenging. We develop a general method for exploring the impact of missing data in such trials, with a focus on abstinence outcomes. Design We propose a sensitivity analysis where standard analyses, which could include ‘missing = smoking’ and ‘last observation carried forward’, are embedded in a wider class of models. Setting We apply our general method to data from two smoking cessation trials. Participants A total of 489 and 1758 participants from two smoking cessation trials. Measurements The abstinence outcomes were obtained using telephone interviews. Findings The estimated intervention effects from both trials depend on the sensitivity parameters used. The findings differ considerably in magnitude and statistical significance under quite extreme assumptions about the missing data, but are reasonably consistent under more moderate assumptions. Conclusions A new method for undertaking sensitivity analyses when handling missing data in trials with binary outcomes allows a wide range of assumptions about the missing data to be assessed. In two smoking cessation trials the results were insensitive to all but extreme assumptions. PMID:25171441
Williams, Geoffrey C; Patrick, Heather; Niemiec, Christopher P; Ryan, Richard M; Deci, Edward L; Lavigne, Holly McGregor
2011-07-01
A previous randomized clinical trial based on self-determination theory (SDT) and consistent with the Public Health Service (PHS) Guideline for Treating Tobacco Use and Dependence demonstrated that an intensive intervention could change autonomous self-regulation and perceived competence, which in part facilitated long-term tobacco abstinence. The current article describes a pragmatic comparative effectiveness trial of three SDT-based intensive tobacco-dependence interventions. Eligible participants are randomized to one of the three treatment conditions designed to facilitate long-term maintenance of tobacco abstinence, namely, Community Care (CC), which includes the 6 month SDT-based intervention previously shown to promote autonomous self-regulation, perceived competence, medication use, and tobacco abstinence; Extended Need Support (ENS), which extends the 6 month SDT-based intervention to 12 months and trains an important other to provide support for smokers' basic psychological needs; and Harm Reduction (HR), which provides extended need support and recommends medication use for participants who do not want to stop smoking completely within 30 days but who are willing to reduce their cigarette use by half. The primary outcome is 12 month prolonged abstinence from tobacco, which is assessed one year following termination of treatment (two years post-randomization). Secondary outcomes include 7- and 30 day point prevalence tobacco abstinence, number of days using smoking-cessation medication, change in autonomous self-regulation and perceived competence, and perceived need support from important others. Copyright © 2011 Elsevier Inc. All rights reserved.
Contingency Management Improves Abstinence and Quality of Life in Cocaine Abusers
ERIC Educational Resources Information Center
Petry, Nancy M.; Alessi, Sheila M.; Hanson, Tressa
2007-01-01
Contingency management (CM) treatments enhance drug abstinence. This study evaluated whether CM also improves quality of life and if these effects are mediated by abstinence. Across 3 independent trials, cocaine abusers in intensive outpatient treatment (n = 387) were randomly assigned to 12 weeks of standard treatment as usual or standard…
Ramo, Danielle E; Thrul, Johannes; Delucchi, Kevin L; Ling, Pamela M; Hall, Sharon M; Prochaska, Judith J
2015-09-15
Tobacco use remains the leading cause of premature morbidity and mortality in the United States. Young adults are less successful at quitting, use cessation treatment less often than smokers of other ages, and can be a challenge to retain in treatment. Social media, integrated into the lives of many young adults, represents a promising strategy to deliver evidence-based smoking cessation treatment to a large, diverse audience. The goal of this trial is to test the efficacy of a stage-based smoking cessation intervention on Facebook for young adults age 18 to 25 on smoking abstinence, reduction in cigarettes smoked, and thoughts about smoking abstinence. This is a randomized controlled trial. Young adult smokers throughout the United States are recruited online and randomized to either the 3 month Tobacco Status Project intervention on Facebook or a referral to a smoking cessation website. The intervention consists of assignment to a secret Facebook group tailored to readiness to quit smoking (precontemplation, contemplation, preparation), daily Facebook contacts tailored to readiness to quit smoking, weekly live counseling sessions, and for those in preparation, weekly Cognitive Behavioral Therapy counseling sessions on Facebook. Primary outcome measure is biochemically-verified 7-day point prevalence abstinence from smoking at posttreatment (3 months), 6, and 12 months. Secondary outcome measures are reduction of 50 % or more in cigarettes smoked, 24 h quit attempts, and commitment to abstinence at each time point. A secondary aim is to test, within the TSP condition, the effect of a monetary incentive at increasing engagement in the intervention. This randomized controlled trial is testing a novel Facebook intervention for treating young adults' tobacco use. If efficacious, the social media intervention could be disseminated widely and expanded to address additional health risks. ClinicalTrials.gov: NCT02207036 , May 13, 2014.
Williams, Geoffrey C.; Patrick, Heather; Niemiec, Christopher P.; Ryan, Richard M.; Deci, Edward L.; Lavigne, Holly McGregor
2011-01-01
A previous randomized clinical trial based on self-determination theory (SDT) and consistent with the Public Health Service (PHS) Guideline for Treating Tobacco Use and Dependence demonstrated that an intensive intervention could change autonomous self-regulation and perceived competence which in part facilitated long-term tobacco abstinence. The current article describes a pragmatic comparative effectiveness trial of three SDT-based intensive tobacco-dependence interventions. Eligible participants are randomized to one of three treatment conditions designed to facilitate long-term maintenance of tobacco abstinence, namely, Community Care (CC), which includes the 6-month SDT-based intervention previously shown to promote autonomous self-regulation, perceived competence, medication use, and tobacco abstinence; Extended Need Support (ENS), which extends the 6-month SDT-based intervention to 12 months and trains an important other to provide support for smokers’ basic psychological needs; and Harm Reduction (HR), which provides extended need support and recommends medication use for participants who do not want to stop smoking completely within 30 days but who are willing to reduce their cigarette use by half. The primary outcome is 12-month prolonged abstinence from tobacco, which is assessed one year following termination of treatment (two years post-randomization). Secondary outcomes include 7- and 30-day point prevalence tobacco abstinence, number of days using smoking-cessation medication, change in autonomous self-regulation and perceived competence, and perceived need support from important others. PMID:21382516
Clinical Trial of Abstinence-Based Vouchers and Cognitive-Behavioral Therapy for Cannabis Dependence
ERIC Educational Resources Information Center
Budney, Alan J.; Moore, Brent A.; Rocha, Heath L.; Higgins, Stephen T.
2006-01-01
Ninety cannabis-dependent adults seeking treatment were randomly assigned to receive cognitive-behavioral therapy, abstinence-based voucher incentives, or their combination. Treatment duration was 14 weeks, and outcomes were assessed for 12 months post treatment. Findings suggest that (a) abstinence-based vouchers were effective for engendering…
Pérez-Tortosa, Santiago; Roig, Lydia; Manresa, Josep M; Martin-Cantera, Carlos; Puigdomènech, Elisa; Roura, Pilar; Armengol, Angelina; Advani, Mamta
2015-01-01
To assess the effectiveness of an intensive smoking cessation intervention based on the transtheoretical model of change (TTM) in diabetic smokers attending primary care. A cluster randomized controlled clinical trial was designed in which the unit of randomization (intervention vs. usual care) was the primary care team. An intensive, individualized intervention using motivational interview and therapies and medications adapted to the patient's stage of change was delivered. The duration of the study was 1 year. A total of 722 people with diabetes who were smokers (345 in the intervention group and 377 in the control group) completed the study. After 1 year, continued abstinence was recorded in 90 (26.1%) patients in the intervention group and in 67 (17.8%) controls (p=0.007). In patients with smoking abstinence, there was a higher percentage in the precontemplation and contemplation stages at baseline in the intervention group than in controls (21.2% vs. 13.7%, p=0.024). When the precontemplation stage was taken as reference (OR=1.0), preparation/action stage at baseline showed a protective effect, decreasing 3.41 times odds of continuing smoking (OR=0.293 95% CI 0.179-0.479, p<0.001). Contemplation stage at baseline also showed a protective effect, decreasing the odds of continuing smoking (OR=0.518, 95% CI 0.318-0.845, p=0.008). An intensive intervention adapted to the individual stage of change delivered in primary care was feasible and effective, with a smoking cessation rate of 26.1% after 1 year. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
Peirce, Jessica M; Petry, Nancy M; Stitzer, Maxine L; Blaine, Jack; Kellogg, Scott; Satterfield, Frank; Schwartz, Marion; Krasnansky, Joe; Pencer, Eileen; Silva-Vazquez, Lolita; Kirby, Kimberly C; Royer-Malvestuto, Charlotte; Roll, John M; Cohen, Allan; Copersino, Marc L; Kolodner, Ken; Li, Rui
2006-02-01
Contingency management interventions that provide tangible incentives based on objective indicators of drug abstinence have improved treatment outcomes of substance abusers, but have not been widely implemented in community drug abuse treatment settings. To compare outcomes achieved when a lower-cost prize-based contingency management treatment is added to usual care in community methadone hydrochloride maintenance treatment settings. Random assignment to usual care with (n = 198) or without (n = 190) abstinence incentives during a 12-week trial. Six community-based methadone maintenance drug abuse treatment clinics in locations across the United States. Three hundred eighty-eight stimulant-abusing patients enrolled in methadone maintenance programs for at least 1 month and no more than 3 years. Participants submitting stimulant- and alcohol-negative samples earned draws for a chance to win prizes; the number of draws earned increased with continuous abstinence time. Total number of stimulant- and alcohol-negative samples provided, percentage of stimulant- and alcohol-negative samples provided, longest duration of abstinence, retention, and counseling attendance. Submission of stimulant- and alcohol-negative samples was twice as likely for incentive as for usual care group participants (odds ratio, 1.98; 95% confidence interval, 1.42-2.77). Achieving 4 or more, 8 or more, and 12 weeks of continuous abstinence was approximately 3, 9, and 11 times more likely, respectively, for incentive vs usual care participants. Groups did not differ on study retention or counseling attendance. The average cost of prizes was 120 dollars per participant. An abstinence incentive approach that paid 120 dollars in prizes per participant effectively increased stimulant abstinence in community-based methadone maintenance treatment clinics.
Müller, Christian A; Geisel, Olga; Pelz, Patricia; Higl, Verena; Krüger, Josephine; Stickel, Anna; Beck, Anne; Wernecke, Klaus-Dieter; Hellweg, Rainer; Heinz, Andreas
2015-08-01
Previous randomized, placebo-controlled trials (RCTs) assessing the efficacy of the selective γ-aminobutyric acid (GABA)-B receptor agonist baclofen in the treatment of alcohol dependence have reported divergent results, possibly related to the low to medium dosages of baclofen used in these studies (30-80mg/d). Based on preclinical observations of a dose-dependent effect and positive case reports in alcohol-dependent patients, the present RCT aimed to assess the efficacy and safety of individually titrated high-dose baclofen for the treatment of alcohol dependence. Out of 93 alcohol-dependent patients initially screened, 56 were randomly assigned to a double-blind treatment with individually titrated baclofen or placebo using dosages of 30-270mg/d. The multiple primary outcome measures were (1) total abstinence and (2) cumulative abstinence duration during a 12-week high-dose phase. More patients of the baclofen group maintained total abstinence during the high-dose phase than those receiving placebo (15/22, 68.2% vs. 5/21, 23.8%, p=0.014). Cumulative abstinence duration was significantly higher in patients given baclofen compared to patients of the placebo group (mean 67.8 (SD 30) vs. 51.8 (SD 29.6) days, p=0.047). No drug-related serious adverse events were observed during the trial. Individually titrated high-dose baclofen effectively supported alcohol-dependent patients in maintaining alcohol abstinence and showed a high tolerability, even in the event of relapse. These results provide further evidence for the potential of baclofen, thereby possibly extending the current pharmacological treatment options in alcohol dependence. Copyright © 2015 Elsevier B.V. and ECNP. All rights reserved.
Walitzer, Kimberly S.; Dermen, Kurt H.; Barrick, Christopher
2009-01-01
AIM This study evaluated two strategies to facilitate involvement in Alcoholics Anonymous (AA) – a 12-step-based directive approach and a motivational enhancement approach – during skills-focused individual treatment. DESIGN Randomized controlled trial with assessments at baseline, end of treatment, and 3, 6, 9, and 12 months after treatment. PARTICIPANTS, SETTING, and INTERVENTION 169 alcoholic outpatients (57 women) randomly assigned to one of three conditions: a directive approach to facilitating AA, a motivational enhancement approach to facilitating AA, or treatment as usual with no special emphasis on AA. MEASUREMENTS Self-report of AA meeting attendance and involvement, alcohol consumption (percent days abstinent, percent days heavy drinking), and negative alcohol consequences. FINDINGS Participants exposed to the 12-step directive condition for facilitating AA involvement reported more AA meeting attendance, more evidence of active involvement in AA, and a higher percent days abstinent relative to participants in the treatment-as-usual comparison group. Evidence suggested also that the effect of the directive strategy on abstinent days was partially mediated through AA involvement. The motivational enhancement approach to facilitating AA had no effect on outcome measures. CONCLUSIONS These results suggest that treatment providers can use a 12-step-based directive approach to effectively facilitate involvement in AA and thereby improve client outcome. PMID:19207347
Mindfulness training for smoking cessation: A meta-analysis of randomized-controlled trials.
Oikonomou, Maria Theodora; Arvanitis, Marios; Sokolove, Robert L
2017-12-01
Recent studies have shown that mindfulness training has a promising potential for smoking treatment. In order to examine the efficacy of mindfulness training in smoking cessation, we performed a systematic review of the literature and meta-analysis of randomized controlled trials. Four randomized controlled trials with 474 patients were included in our analysis. The results showed that 25.2 percent of participants remained abstinent for more than 4 months in the mindfulness group compared to 13.6 percent of those who received usual care therapy (relative risk, 1.88; 95 percent confidence interval, 1.04-3.40). Our results suggest that mindfulness training may have an important role to play in efforts to lower cigarette smoking rates.
Breitkopf, Carmen Radecki; Loza, Melissa; Vincent, Kathleen; Moench, Thomas; Stanberry, Lawrence R.; Rosenthal, Susan L.
2011-01-01
Background Developing effective and safe microbicides requires study procedures (e.g. technology used, abstinence requirements, and product use) that are acceptable to participants. Methods Thirty women completed 4 study visits including pelvic examination, colposcopy, optical coherence tomography (OCT), and semi-structured, qualitative interviews. Additional requirements included abstinence (for approximately 16 days) and twice daily vaginal product use (for 5.5 days). Interviews were audio-recorded, transcribed, and analyzed using framework analysis. Themes addressing OCT experiences, acceptability of abstinence, and vaginal product use were examined. Results OCT was viewed favorably as an imaging technology. Some women reported feeling the fiber-optic probe “poking” them and over one-third spontaneously reported feeling pressure or pinching upon rotation of the speculum in connection with the OCT evaluation. Compliance with vaginal gel use was high, but for many women assigned to use a product containing nonoxynol-9 (versus placebo), the post-product use exam was more uncomfortable, relative to the initial exam or one week following product discontinuation. Nearly all women experienced product leakage; acceptability of leakage varied. Two women were not abstinent and several more found abstinence challenging. Some women involved their partner in decision making regarding trial enrollment. Strategies to remain abstinent included participating when the partner was away, avoiding early intimacy, and engaging in alternative sexual activities. Conclusions Qualitative interviews in early-phase studies provide insights and capture information that would be missed by behavioral inference alone. Understanding participant’s experiences is important in order to provide anticipatory guidance and plan future microbicide studies that facilitate adherence with trial requirements. PMID:22183842
Murphy, Sean M.; Campbell, Aimee N. C.; Ghitza, Udi E.; Kyle, Tiffany L.; Bailey, Genie L.; Nunes, Edward V.; Polsky, Daniel
2016-01-01
Background Substance misuse and excessive alcohol consumption are major public health issues. Internet-based interventions for substance use disorders (SUDs) are a relatively new method for addressing barriers to access and supplementing existing care. This study examines cost-effectiveness in a multisite, randomized trial of an internet-based version of the community reinforcement approach (CRA) with contingency management (CM) known as the Therapeutic Education System (TES). Methods Economic evaluation of the 12-week trial with follow-up at 24 and 36 weeks. 507 individuals who were seeking therapy for alcohol or other substance use disorders at 10 outpatient community-based treatment programs were recruited and randomized to either treatment as usual (TAU) or TES+TAU. Sub-analyses were completed on participants with a poorer prognosis (i.e., those not abstinent at study entry). Results From the provider’s perspective, TES+TAU as it was implemented in this study costs $278 (SE=87) more than TAU alone after 12 weeks. The quality-adjusted life years gained by TES+TAU and TAU were similar; however, TES+TAU has at least a 95% chance of being considered cost-effective for providers and payers with willingness-to-pay thresholds as low as $20,000 per abstinent year. Findings for the subgroup not abstinent at study entry are slightly more favorable. Conclusions With regard to the clinical outcome of abstinence, our cost-effectiveness findings of TES+TAU compare favorably to those found elsewhere in the CM literature. The analyses performed here serve as an initial economic framework for future studies integrating technology into SUD therapy. Clinical trial registration NCT01104805. PMID:26880594
Cooney, Judith L; Cooper, Sharon; Grant, Christoffer; Sevarino, Kevin; Krishnan-Sarin, Suchitra; Gutierrez, Ian A; Cooney, Ned L
2017-01-01
This randomized clinical trial was designed to evaluate the efficacy of contingency management (CM) for smoking cessation for smokers with alcohol abuse or dependence delivered concurrently with intensive outpatient alcohol treatment. The study also explored the indirect effects of CM smoking treatment and smoking cessation on alcohol and drug use outcomes. Alcohol abuse/dependent smokers were randomized to cognitive behavioral therapy plus nicotine replacement therapy plus contingency management (CBT+NRT+CM) or to cognitive behavior therapy plus nicotine replacement therapy (CBT+NRT) delivered concurrent with a three-week intensive outpatient alcohol treatment program. Participants in the CBT+NRT+CM condition were significantly more likely to be cigarette abstinent at the end of treatment (χ 2 (1)=8.48, p=.004) with approximately double the carbon monoxide confirmed quit rate (60%) compared with the CBT+NRT condition (29%). At the one-month and six-month time-points there were nonsignificant differences in smoking abstinence outcomes by condition. Smoking treatment condition did not directly affect alcohol abstinence outcomes, but we observed an indirect effect of smoking treatment on alcohol and drug abstinence at one-month follow-up that was mediated by smoking cessation at the end of treatment. Adding CM to an evidence-based smoking cessation treatment that included medication and behavioral counseling doubled the quit rate at the end of treatment. This finding provides strong evidence for the efficacy of CM for helping alcohol dependent smokers reach the milestone of initial smoking abstinence. Published by Elsevier Inc.
THE EFFECTS OF FIXED VERSUS ESCALATING REINFORCEMENT SCHEDULES ON SMOKING ABSTINENCE
Romanowich, Paul; Lamb, R. J.
2015-01-01
Studies indicate that when abstinence is initiated, escalating reinforcement schedules maintain continuous abstinence longer than fixed reinforcement schedules. However, these studies were conducted for shorter durations than most clinical trials and also resulted in larger reinforcer value for escalating participants during the 1st week of the experiment. We tested whether escalating reinforcement schedules maintained abstinence longer than fixed reinforcement schedules in a 12-week clinical trial. Smokers (146) were randomized to an escalating reinforcement schedule, a fixed reinforcement schedule, or a control condition. Escalating reinforcement participants received $5.00 for their first breath carbon monoxide (CO) sample <3 ppm, with a $0.50 increase for each consecutive sample. Fixed reinforcement participants received $19.75 for each breath CO sample <3 ppm. Control participants received payments only for delivering a breath CO sample. Similar proportions of escalating and fixed reinforcement participants met the breath CO criterion at least once. Escalating reinforcement participants maintained criterion breath CO levels longer than fixed reinforcement and control participants. Similar to previous short-term studies, escalating reinforcement schedules maintained longer durations of abstinence than fixed reinforcement schedules during a clinical trial. PMID:25640764
Brandon, Thomas H; Klesges, Robert C; Ebbert, Jon O; Talcott, Gerald W; Thomas, Fridtjof; Leroy, Karen; Richey, Phyllis A; Colvin, Lauren
2014-05-01
Smoking cessation is a primary method of reducing excess mortality and morbidity. Unfortunately, the vast majority of cessation attempts end in eventual relapse. Relapse-prevention interventions have shown some success at improving the long-term maintenance of tobacco abstinence among individuals motivated to abstain. However, involuntary tobacco abstinence (e.g., military training, hospitalization, incarceration) presents another opportunity for intervention to prevent relapse. During basic military training (BMT), tobacco use is strictly forbidden in all service branches, but tobacco relapse (and initiation) following BMT is extremely high. This paper reports on the design, intervention development, and baseline characteristics of a randomized controlled trial testing minimal interventions designed to prevent tobacco relapse among United States Air Force (USAF) personnel following BMT. Participants are randomized by squadron to receive either a standard smoking-cessation booklet, a new motivation-based booklet designed specifically for USAF personal, or the latter booklet combined with a brief, face-to-face motivational session. Primary outcomes will be self-reported tobacco use at 12 and 24month follow-up. Given that the Department of Defense is the world's largest employer, the potential of leveraging involuntary tobacco abstinence during BMT into extended abstinence has substantial public health significance. Copyright © 2014 Elsevier Inc. All rights reserved.
Marissen, Marlies A E; Franken, Ingmar H A; Blanken, Peter; van den Brink, Wim; Hendriks, Vincent M
2007-01-01
Persistent cue reactivity to drug-related stimuli is a well-known phenomenon among abstinent drug users and has been found to be a predictor of relapse. Cue exposure therapy (CET) aims to reduce this cue reactivity by exposing abstinent drug users to conditioned drug-related stimuli while preventing their habitual response, i.e. drug use. 127 abstinent heroin-dependent Dutch inpatients were randomized to CET (n = 65; 55 completers) and placebo psychotherapy treatment (PPT) (n = 62; 59 completers). It was examined whether CET would lead to a decrease in drug-related cue reactivity (using mixed-design ANOVA) and subsequently to lower dropout and relapse rates (using logistic regression) compared to PPT. Both groups responded with a similar decrease in self-reported cue reactivity (craving, mood). The CET group did show a significant decrease in physiological reactivity (skin conductance) compared to PPT. However, dropout and relapse rates were, contrary to our expectations, significantly higher in the CET group. This is the first randomized controlled trial showing that CET, compared to a non-specific psychotherapy, might increase dropout and relapse rates among abstinent heroin-dependent clients in a drug-free setting. Caution is warranted when applying CET in this specific context. Copyright 2007 S. Karger AG, Basel.
Exercise counseling to enhance smoking cessation outcomes: the Fit2Quit randomized controlled trial.
Maddison, Ralph; Roberts, Vaughan; McRobbie, Hayden; Bullen, Christopher; Prapavessis, Harry; Glover, Marewa; Jiang, Yannan; Brown, Paul; Leung, William; Taylor, Sue; Tsai, Midi
2014-10-01
Regular exercise has been proposed as a potential smoking cessation aid. This study aimed to determine the effects of an exercise counseling program on cigarette smoking abstinence at 24 weeks. A parallel, two-arm, randomized controlled trial was conducted. Adult cigarette smokers (n = 906) who were insufficiently active and interested in quitting were randomized to receive the Fit2Quit intervention (10 exercise telephone counseling sessions over 6 months) plus usual care (behavioral counseling and nicotine replacement therapy) or usual care alone. There were no significant group differences in 7-day point-prevalence and continuous abstinence at 6 months. The more intervention calls successfully delivered, the lower the probability of smoking (OR, 0.88; 95 % CI 0.81-0.97, p = 0.01) in the intervention group. A significant difference was observed for leisure time physical activity (difference = 219.11 MET-minutes/week; 95 % CI 52.65-385.58; p = 0.01). Telephone-delivered exercise counseling may not be sufficient to improve smoking abstinence rates over and above existing smoking cessation services. (Australasian Clinical Trials Registry Number: ACTRN12609000637246.).
A Randomized Trial of Motivational Interviewing
Catley, Delwyn; Goggin, Kathy; Harris, Kari Jo; Richter, Kimber P.; Williams, Karen; Patten, Christi; Resnicow, Ken; Ellerbeck, Edward F.; Bradley-Ewing, Andrea; Lee, Hyoung S.; Moreno, Jose L.; Grobe, James E.
2015-01-01
Introduction Despite limitations in evidence, the current Clinical Practice Guideline advocates Motivational Interviewing for smokers not ready to quit. This study evaluated the efficacy of Motivational Interviewing (MI) for inducing cessation-related behaviors among smokers with low motivation to quit. Design Randomized clinical trial. Setting/participants Two-hundred fifty-five daily smokers reporting low desire to quit smoking were recruited from an urban community during 2010–2011 and randomly assigned to Motivational Interviewing, health education, or brief advice using a 2:2:1 allocation. Data were analyzed from 2012 to 2014. Intervention Four sessions of Motivational Interviewing utilized a patient-centered communication style that explored patients’ own reasons for change. Four sessions of health education provided education related to smoking cessation while excluding elements characteristic of Motivational Interviewing. A single session of brief advice consisted of brief, personalized advice to quit. Main outcomes measures Self-reported quit attempts, smoking abstinence (biochemically verified), use of cessation pharmacotherapies, motivation, and confidence to quit were assessed at baseline and 3- and 6-month follow-ups. Results Unexpectedly, no significant differences emerged between groups in the proportion who made a quit attempt by 6-month follow-up (Motivational Interviewing, 52.0%; health education, 60.8%; brief advice, 45.1%; p=0.157). Health education had significantly higher biochemically verified abstinence rates at 6 months (7.8%) than brief advice (0.0%) (8% difference, 95% CI=3%, 13%, p=0.003), with the Motivational Interviewing group falling in between (2.9% abstinent, 3% risk difference, 95% CI=0%, 6%, p=0.079). Both Motivational Interviewing and health education groups showed greater increases in cessation medication use, motivation, and confidence to quit relative to brief advice (all p<0.05), and health education showed greater
Cassidy, Rachel N; Jackson, Kristina M; Rohsenow, Damaris J; Tidey, Jennifer W; Tevyaw, Tracy O' L; Barnett, Nancy P; Monti, Peter M; Miller, Mollie E; Colby, Suzanne M
2018-05-01
Contingency management (CM) is effective for promoting smoking abstinence; however, moderators and mediators of CM treatment efficacy in young adult populations are under-explored. We leveraged fine-grained data from a large randomized controlled trial: 1) to determine whether early attainment of sustained abstinence mediated the effect of treatment on abstinence; 2) to test whether heavy drinking moderated the effect of treatment on abstinence; and 3) to test a serial mediation model of the effects of drinking during early treatment on sustained smoking abstinence. College student smokers (N=110) were randomized to receive either CM treatment or noncontingent reinforcement (NR) over a 21-day treatment period. All participants received $5 for providing twice-daily breath carbon monoxide (CO) samples. In CM, additional money was provided for samples that indicated smoking reduction (Initial Phase; first 7days), and for samples ≤5ppm (Abstinence Phase; following 14days). CM treatment led to greater sustained abstinence relative to NR. Longer sustained abstinence in the Initial Phase partially mediated the effect of treatment on sustained abstinence in the Abstinence Phase. Heavier pretreatment drinkers had shorter periods of sustained abstinence in the Abstinence Phase; this effect was greater in CM. A serial mediation model determined that increased drinking during the Initial Phase led to decreased sustained abstinence, which then led to decreased sustained abstinence in the Abstinence Phase. These data provide a greater understanding of how heavy drinking and early sustained abstinence may affect success during treatment in young adults undergoing contingency management treatment for smoking. Copyright © 2018. Published by Elsevier Ltd.
Perinatal Substance Use: A Prospective Evaluation of Abstinence and Relapse
Forray, Ariadna; Merry, Brian; Lin, Haiqun; Ruger, Jennifer Prah; Yonkers, Kimberly A.
2015-01-01
Background Substance use decreases in pregnancy but little prospective data are available on the rates of abstinence and relapse for specific substances. This study compared rates of abstinence in pregnancy and relapse postpartum for nicotine cigarettes, alcohol, marijuana, and cocaine. Methods Data from 152 women drawn from a randomized controlled trial comparing psychological treatments for substance use in pregnancy were analyzed. Self-reports of substance use and urine for toxicology testing throughout pregnancy and 3-months, 12-months and 24-months post-delivery were collected. Multivariate Cox models were used to compare rates of abstinence and relapse across substances. Results In pregnancy, 83% of all women achieved abstinence to at least one substance. The mean (SE) days to abstinence was 145.81 (9.17), 132.01 (6.17), 151.52 (6.24), and 148.91 (7.68) for cigarettes, alcohol, marijuana and cocaine, respectively. Participants were more likely to achieve abstinence from alcohol (HR 7.24 (95% CI 4.47-11.72), marijuana (HR 4.06; 95% CI 1.87-6.22), and cocaine (HR 3.41; 95% CI 2.53-6.51), than cigarettes. Postpartum, 80% of women abstinent in the last month of pregnancy relapsed to at least one substance. The mean days to relapse was 109.67 (26.34), 127.73 (21.29), 138.35 (25.46), and 287.55 (95.85) for cigarettes, alcohol, marijuana and cocaine, respectively. Relapse to cocaine was only 34% (HR 0.34; 95% CI 0.15-0.77) that of cigarettes. Conclusions Pregnancy-related abstinence rates were high for all substances except cigarettes. Postpartum relapse was common, with cocaine using women being less likely to relapse after attaining abstinence compared to women using cigarettes, alcohol or marijuana. PMID:25772437
Proactive tobacco treatment and population-level cessation: a pragmatic randomized clinical trial.
Fu, Steven S; van Ryn, Michelle; Sherman, Scott E; Burgess, Diana J; Noorbaloochi, Siamak; Clothier, Barbara; Taylor, Brent C; Schlede, Carolyn M; Burke, Randy S; Joseph, Anne M
2014-05-01
Current tobacco use treatment approaches require smokers to request treatment or depend on the provider to initiate smoking cessation care and are therefore reactive. Most smokers do not receive evidence-based treatments for tobacco use that include both behavioral counseling and pharmacotherapy. To assess the effect of a proactive, population-based tobacco cessation care model on use of evidence-based tobacco cessation treatments and on population-level smoking cessation rates (ie, abstinence among all smokers including those who use and do not use treatment) compared with usual care among a diverse population of current smokers. The Veterans Victory Over Tobacco Study, a pragmatic randomized clinical trial involving a population-based registry of current smokers aged 18 to 80 years. A total of 6400 current smokers, identified using the Department of Veterans Affairs (VA) electronic medical record, were randomized prior to contact to evaluate both the reach and effectiveness of the proactive care intervention. Current smokers were randomized to usual care or proactive care. Proactive care combined (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or in-person). Proactive outreach included mailed invitations followed by telephone outreach to motivate smokers to seek treatment with choice of services. The primary outcome was 6-month prolonged smoking abstinence at 1 year and was assessed by a follow-up survey among all current smokers regardless of interest in quitting or treatment utilization. A total of 5123 participants were included in the primary analysis. The follow-up survey response rate was 66%. The population-level, 6-month prolonged smoking abstinence rate at 1 year was 13.5% for proactive care compared with 10.9% for usual care (P = .02). Logistic regression mixed model analysis showed a significant effect of the proactive care intervention on 6-month prolonged abstinence (odds ratio [OR], 1.27 [95% CI, 1
Andrews, Jeannette O; Mueller, Martina; Dooley, Mary; Newman, Susan D; Magwood, Gayenell S; Tingen, Martha S
2016-09-01
To evaluate the effectiveness of a community based participatory research (CBPR) developed, multi-level smoking cessation intervention among women in subsidized housing neighborhoods in the Southeastern US. A total of n=409 women in 14 subsidized housing neighborhoods in Georgia and South Carolina participated in this group randomized controlled trial conducted from 2009 to 2013. Intervention neighborhoods received a 24-week intervention with 1:1 community health worker contact, behavioral peer group sessions, and nicotine replacement. Control neighborhoods received written cessation materials at weeks 1, 6, 12, 18. Random coefficient models were used to compare smoking abstinence outcomes at 6 and 12months. Significance was set a p<0.05. The majority of participants (91.2%) were retained during the 12-month intervention period. Smoking abstinence rates at 12months for intervention vs. control were 9% vs. 4.3%, p=0.05. Additional analyses accounting for passive smoke exposure in these multi-unit housing settings demonstrated 12month abstinence rates of 12% vs. 5.3%, p=0.016. However, in the multivariate regression analyses, there was no significant effect of the intervention on the odds of being a non-smoker (OR=0.44, 95% CI: 0.18-1.07). Intervention participants who kept coach visits, attended group sessions, and used patches were more likely to remain abstinent. This CBPR developed intervention showed potential to engage smokers and reduce smoking among women in these high-poverty neighborhoods. Effectiveness in promoting cessation in communities burdened with fiscal, environmental and social inequities remains a public health priority. Copyright © 2016 Elsevier Inc. All rights reserved.
The role of gender in a smoking cessation intervention: a cluster randomized clinical trial
2011-01-01
Background The prevalence of smoking in Spain is high in both men and women. The aim of our study was to evaluate the role of gender in the effectiveness of a specific smoking cessation intervention conducted in Spain. Methods This study was a secondary analysis of a cluster randomized clinical trial in which the randomization unit was the Basic Care Unit (family physician and nurse who care for the same group of patients). The intervention consisted of a six-month period of implementing the recommendations of a Clinical Practice Guideline. A total of 2,937 current smokers at 82 Primary Care Centers in 13 different regions of Spain were included (2003-2005). The success rate was measured by a six-month continued abstinence rate at the one-year follow-up. A logistic mixed-effects regression model, taking Basic Care Units as random-effect parameter, was performed in order to analyze gender as a predictor of smoking cessation. Results At the one-year follow-up, the six-month continuous abstinence quit rate was 9.4% in men and 8.5% in women (p = 0.400). The logistic mixed-effects regression model showed that women did not have a higher odds of being an ex-smoker than men after the analysis was adjusted for confounders (OR adjusted = 0.9, 95% CI = 0.7-1.2). Conclusions Gender does not appear to be a predictor of smoking cessation at the one-year follow-up in individuals presenting at Primary Care Centers. ClinicalTrials.gov Identifier NCT00125905. PMID:21605389
Jain, Raka; Jhanjee, Sonali; Jain, Veena; Gupta, Tina; Mittal, Swati; Chauhan, Prashant; Raghav, Rahul; Goelz, Patricia; Schnoll, Robert A
2015-01-01
The validity of self-reported tobacco use is often questioned given the potential for underestimation of use. This study used data from a double-blind, placebo-controlled clinical trial of varenicline for smokeless tobacco dependence in India to evaluate the accuracy of self-reported smokeless tobacco cessation using biochemical validation procedures and to evaluate correlates of reporting inaccuracy. Smokeless tobacco users attending a dental clinic at AIIMS were randomized to placebo or varenicline; all participants received counseling. Detailed smokeless tobacco use was recorded and abstinence was defined as cotinine-verified 7-day point prevalence cessation (cotinine < 50 ng/ml) and breath CO > 10 ppm at the end of 12 weeks of treatment. One-half of study completers (82/165) self-reported abstinence. Biochemical verification confirmed that (65.9%) subjects provided accurate self-reports while (34.1%) participants underreported tobacco use. These data indicate poor agreement between self-reported and biochemically confirmed abstinence (κ = -0.191). Underreporters of tobacco use had significantly higher baseline cotinine (p < 0.05), total craving (p < 0.012), and negative reinforcement craving (p < 0.001) vs. those whose self-reports were correctly verified. These findings provide evidence to support the need for biochemical validation of self-reported abstinence outcomes among smokeless tobacco users in cessation programs in India and identify high levels of pretreatment cotinine and craving levels as potential correlates of false reporting.
Paths to tobacco abstinence: A repeated-measures latent class analysis.
McCarthy, Danielle E; Ebssa, Lemma; Witkiewitz, Katie; Shiffman, Saul
2015-08-01
Knowledge of smoking change processes may be enhanced by identifying pathways to stable abstinence. We sought to identify latent classes of smokers based on their day-to-day smoking status in the first weeks of a cessation attempt. We examined treatment effects on class membership and compared classes on baseline individual differences and 6-month abstinence rates. In this secondary analysis of a double-blind randomized placebo-controlled clinical trial (N = 1,433) of 5 smoking cessation pharmacotherapies (nicotine patch, nicotine lozenge, bupropion SR, patch and lozenge, or bupropion SR and lozenge), we conducted repeated-measures latent class analysis of daily smoking status (any smoking vs. none) for the first 27 days of a quit attempt. Treatment and covariate relations with latent class membership were examined. Distal outcome analysis compared confirmed 6-month abstinence rates among the latent classes. A 5-class solution was selected. Three-quarters of smokers were in stable smoking or abstinent classes, but 25% were in classes with unstable abstinence probabilities over time. Active treatment (compared to placebo), and particularly the patch and lozenge combination, promoted early quitting. Latent classes differed in 6-month abstinence rates and on several baseline variables, including nicotine dependence, quitting history, self-efficacy, sleep disturbance, and minority status. Repeated-measures latent class analysis identified latent classes of smoking change patterns affected by treatment, related to known risk factors, and predictive of distal outcomes. Tracking behavior early in a change attempt may identify prognostic patterns of change and facilitate adaptive treatment planning. (c) 2015 APA, all rights reserved).
2012-01-01
Background Tobacco smoking is the leading avoidable cause of death in high-income countries. The smoking-related disease burden is borne primarily by the least educated and least affluent groups. Thus, there is a need for effective smoking cessation interventions that reach to, and are effective in this group. Research suggests that modest financial incentives are not very effective in helping smokers quit. What is not known is whether large financial incentives can enhance longer-term (1 year) smoking cessation rates, outside clinical and workplace settings. Trial design A randomized, parallel groups, controlled trial. Methods Participants: Eight hundred low-income smokers in Switzerland (the less affluent third of the population, based on fiscal taxation). Intervention: A smoking cessation program including: (a) financial incentives given during 6 months; and (b) Internet-based counseling. Financial rewards will be offered for biochemically verified smoking abstinence after 1, 2, and 3 weeks and 1, 3, and 6 months, for a maximum of 1,500 CHF (1,250 EUR, 1,500 USD) for those abstinent at all time-points. All participants, including controls, will receive Internet-based, individually-tailored, smoking cessation counseling and self-help booklets, but there will be no in-person or telephone counseling, and participants will not receive medications. The control group will not receive financial incentives. Objective: To increase smoking cessation rates. Outcome: Smoking abstinence after 6 and 18 months, not contradicted by biochemical tests. We will assess relapse after the end of the intervention, to test whether 6-month effects translate into sustained abstinence 12 months after the incentives are withdrawn. Randomization: Will be done using sealed envelopes drawn by participants. Blinding: Is not possible in this context. Discussion Smoking prevention policies and interventions have been least effective in the least educated, low-income groups. Combining
Steinberg, Michael B; Randall, Jennifer; Greenhaus, Shelley; Schmelzer, Amy C; Richardson, Donna L; Carson, Jeffrey L
2011-12-01
The hospital can be an important opportunity for smoking cessation interventions. This is the first randomized, double-blinded, placebo-controlled pilot trial utilizing varenicline and post-discharge, in-person behavioral treatment for hospitalized smokers. Seventy-nine smokers admitted to a university-based hospital with various diagnoses were enrolled from 2007 to 2009. The primary outcome was biochemically confirmed abstinence at 24 weeks following discharge. Secondary outcomes included withdrawal symptoms, motivation, utilization of treatment, and medical events. Overall abstinence at 24 weeks was 27% with no difference between varenicline and placebo treatment groups (23% vs. 31%). There were no significant differences in motivation to stop smoking or withdrawal symptoms. Over 40% of all subjects utilized post-discharge behavioral treatment with significantly higher abstinence rates compared with those who did not (53.1% vs. 8.5%, p<0.01). Overall adverse events were similar in both treatment groups with the only significant difference being more nausea in the varenicline group (25% vs. 5%; p<0.01). Twenty-three subjects were re-hospitalized with no significant differences between treatment groups (13 varenicline vs. 10 placebo). This pilot trial of varenicline in hospitalized smokers demonstrated feasibility of implementation, produced some hypothesis-generating findings, and suggested the potential benefit of face-to-face treatment following discharge. Copyright © 2011 Elsevier Ltd. All rights reserved.
Murphy, Sean M; Campbell, Aimee N C; Ghitza, Udi E; Kyle, Tiffany L; Bailey, Genie L; Nunes, Edward V; Polsky, Daniel
2016-04-01
Substance misuse and excessive alcohol consumption are major public health issues. Internet-based interventions for substance use disorders (SUDs) are a relatively new method for addressing barriers to access and supplementing existing care. This study examines cost-effectiveness in a multisite, randomized trial of an internet-based version of the community reinforcement approach (CRA) with contingency management (CM) known as the Therapeutic Education System (TES). Economic evaluation of the 12-week trial with follow-up at 24 and 36 weeks. 507 individuals who were seeking therapy for alcohol or other substance use disorders at 10 outpatient community-based treatment programs were recruited and randomized to either treatment as usual (TAU) or TES+TAU. Sub-analyses were completed on participants with a poorer prognosis (i.e., those not abstinent at study entry). From the provider's perspective, TES+TAU as it was implemented in this study costs $278 (SE=87) more than TAU alone after 12 weeks. The quality-adjusted life years gained by TES+TAU and TAU were similar; however, TES+TAU has at least a 95% chance of being considered cost-effective for providers and payers with willingness-to-pay thresholds as low as $20,000 per abstinent year. Findings for the subgroup not abstinent at study entry are slightly more favorable. With regard to the clinical outcome of abstinence, our cost-effectiveness findings of TES+TAU compare favorably to those found elsewhere in the CM literature. The analyses performed here serve as an initial economic framework for future studies integrating technology into SUD therapy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
Miguel, André Q. C.; Madruga, Clarice S.; Cogo-Moreira, Hugo; Yamauchi, Rodolfo; Simões, Viviane; da Silva, Claudio J.; McPherson, Sterling; Roll, John M.; Laranjeira, Ronaldo R.
2016-01-01
BACKGROUND Crack cocaine dependence has become a severe public health problem in Brazil, and current psychosocial approaches to this problem have shown little or no effectiveness. Although contingency management is among the most effective behavioral treatments for substance use disorders, it has never been applied in the treatment of crack cocaine-dependent individuals in Brazil. AIMS To evaluate the efficacy of incorporating contingency management into standard outpatient treatment for crack cocaine dependence, as well as the impact that doing so has on treatment attendance, retention in treatment, maintenance of abstinence, and the frequency of substance use. METHODS We evaluated 65 treatment-seeking, crack cocaine-dependent individuals, randomized to receive 12 weeks of standard treatment plus contingency management (STCM; n = 33) or 12 weeks of standard treatment alone (STA; n = 32). Those in the STCM group received monetary incentives for being abstinent, earning up to US$235.50 if they remained abstinent throughout the entire treatment period. RESULTS The STCM group participants attended a mean of 19.5 (SD = 14.9) treatment sessions, compared with 3.7 (SD = 5.9) for the STA group participants (p < 0.01). Those in the STCM group were 3.8, 4.6, and 68.9 times more likely to be retained in treatment at weeks 4, 8, and 12 than were those in the STA group. The likelihood of detecting 4, 8, and 12 weeks of continuous abstinence was 17.7, 9.9, and 18.6 times higher in the STCM group than in the STA group (p < 0.05). Compared to the STA group, the STCM group submitted a significantly higher proportion of crack cocaine, THC, and alcohol negative samples (p < 0.001) when all expected samples were included in the denominator, but not when only submitted samples were considered. The average monthly cost/participant for incentives was $29.00. CONCLUSIONS Contingency management showed efficacy in a sample of Brazilian crack cocaine users. The intervention holds promise
Miguel, André Q C; Madruga, Clarice S; Cogo-Moreira, Hugo; Yamauchi, Rodolfo; Simões, Viviane; da Silva, Claudio J; McPherson, Sterling; Roll, John M; Laranjeira, Ronaldo R
2016-08-01
Crack cocaine dependence has become a severe public health problem in Brazil, and current psychosocial approaches to this problem have shown little or no effectiveness. Although contingency management is among the most effective behavioral treatments for substance use disorders, it has never been applied in the treatment of crack cocaine-dependent individuals in Brazil. The aim of this study was to evaluate the efficacy of incorporating contingency management into standard outpatient treatment for crack cocaine dependence, as well as the impact that doing so has on treatment attendance, retention in treatment, maintenance of abstinence, and the frequency of substance use. We evaluated 65 treatment-seeking, crack cocaine-dependent individuals, randomized to receive 12 weeks of standard treatment plus contingency management (STCM; n = 33) or 12 weeks of standard treatment alone (STA; n = 32). Those in the STCM group received monetary incentives for being abstinent, earning up to US$235.50 if they remained abstinent throughout the entire treatment period. The STCM group participants attended a mean of 19.5 (SD = 14.9) treatment sessions, compared with 3.7 (SD = 5.9) for the STA group participants (p < .01). Those in the STCM group were 3.8, 4.6, and 68.9 times more likely to be retained in treatment at weeks 4, 8, and 12 than were those in the STA group. The likelihood of detecting 4, 8, and 12 weeks of continuous abstinence was 17.7, 9.9, and 18.6 times higher in the STCM group than in the STA group (p < .05). Compared to the STA group, the STCM group submitted a significantly higher proportion of negative samples for crack cocaine, delta-9-tetrahydrocannabinol, and alcohol (p < .001) when all expected samples were included in the denominator but not when only submitted samples were considered. The average monthly cost/participant for incentives was $29.00. Contingency management showed efficacy in a sample of Brazilian crack cocaine users. The intervention holds
2013-01-01
Background Intensive interventions on smoking cessation increase abstinence rates. However, few electronic mail (E-mail) based intensive interventions have been tested in smokers and none in primary care (PC) setting. The aim of the present study is to evaluate the effectiveness of an intensive E-mail based intervention in smokers attending PC services. Methods/design Randomized Controlled Multicentric Trial. Study population: 1060 smokers aged between 18–70 years from Catalonia, Salamanca and Aragón (Spain) who have and check regularly an E-mail account. Patients will be randomly assigned to control or intervention group. Intervention: Six phase intensive intervention with two face to face interviews and four automatically created and personal E-mail patients tracking, if needed other E-mail contacts will be made. Control group will receive a brief advice on smoking cessation. Outcome measures: Will be measured at 6 and 12 months after intervention: self reported continuous abstinence (confirmed by cooximetry), point prevalence abstinence, tobacco consumption, evolution of stage according to Prochaska and DiClemente's Stages of Change Model, length of visit, costs for the patient to access Primary Care Center. Statistical analysis: Descriptive and logistic and Poisson regression analysis under the intention to treat basis using SPSS v.17. Discussion The proposed intervention is an E-mail based intensive intervention in smokers attending primary care. Positive results could be useful to demonstrate a higher percentage of short and long-term abstinence among smokers attended in PC in Spain who regularly use E-mail. Furthermore, this intervention could be helpful in all health services to help smokers to quit. Trial Registration Clinical Trials.gov Identifier: NCT01494246. PMID:23597262
Graham, Amanda L; Papandonatos, George D; Cha, Sarah; Erar, Bahar; Amato, Michael S
2018-03-15
Partial adherence in Internet smoking cessation interventions presents treatment and evaluation challenges. Increasing adherence may improve outcomes. To present smoking outcomes from an Internet randomized trial of two strategies to encourage adherence to tobacco dependence treatment components: (i) a social network (SN) strategy to integrate smokers into an online community and (ii) free nicotine replacement therapy (NRT). In addition to intent-to-treat analyses, we used novel statistical methods to distinguish the impact of treatment assignment from treatment utilization. A total of 5,290 current smokers on a cessation website (WEB) were randomized to WEB, WEB + SN, WEB + NRT, or WEB + SN + NRT. The main outcome was 30-day point prevalence abstinence at 3 and 9 months post-randomization. Adherence measures included self-reported medication use (meds), and website metrics of skills training (sk) and community use (comm). Inverse Probability of Retention Weighting and Inverse Probability of Treatment Weighting jointly addressed dropout and treatment selection. Propensity weights were used to calculate Average Treatment effects on the Treated. Treatment assignment analyses showed no effects on abstinence for either adherence strategy. Abstinence rates were 25.7%-32.2% among participants that used all three treatment components (sk+comm +meds).Treatment utilization analyses revealed that among such participants, sk+comm+meds yielded large percentage point increases in 3-month abstinence rates over sk alone across arms: WEB = 20.6 (95% CI = 10.8, 30.4), WEB + SN = 19.2 (95% CI = 11.1, 27.3), WEB + NRT = 13.1 (95% CI = 4.1, 22.0), and WEB + SN + NRT = 20.0 (95% CI = 12.2, 27.7). Novel propensity weighting approaches can serve as a model for establishing efficacy of Internet interventions and yield important insights about mechanisms. NCT01544153.
van den Brand, F A; Nagelhout, G E; Winkens, B; Evers, S M A A; Kotz, D; Chavannes, N H; van Schayck, C P
2016-10-06
Stimulating successful tobacco cessation among employees has multiple benefits. Employees who quit tobacco are healthier, more productive, less absent from work, and longer employable than employees who continue to use tobacco. Despite the evidence for these benefits of tobacco cessation, a successful method to stimulate employees to quit tobacco is lacking. The aim of this study is to evaluate whether adding a financial incentive to behavioral support (compared with no additional incentive) is effective and cost-effective in increasing abstinence rates in tobacco smoking employees participating in a smoking cessation group training. In this cluster-randomized trial employees in the intervention and control group both participate in a smoking cessation group training consisting of seven weekly counseling sessions of ninety minutes each. In addition to the training, employees in the intervention group receive a voucher as an incentive for being abstinent from smoking at the end of the training (€50), after three months (€50), after six months (€50), and after one year (€200). The control group does not receive any incentive. The primary outcome is carbon monoxide validated 12-month continuous abstinence from smoking (Russel's standard). Additionally, an economic evaluation is performed from a societal and an employer perspective. The present paper describes the methods and design of this cluster-randomized trial in detail. We hypothesize that the financial incentive for abstinence in the form of vouchers increases abstinence rates over and above the group training. The results of this study can provide important recommendations for enhancement of employee tobacco cessation. Dutch Trial Register: NTR5657 . First received 27-01-2016.
ERIC Educational Resources Information Center
McKay, James R.; Lynch, Kevin G.; Coviello, Donna; Morrison, Rebecca; Cary, Mark S.; Skalina, Lauren; Plebani, Jennifer
2010-01-01
Objective: The effects of cognitive-behavioral relapse prevention (RP), contingency management (CM), and their combination (CM + RP) were evaluated in a randomized trial with 100 cocaine-dependent patients (58% female, 89% African American) who were engaged in treatment for at least 2 weeks and had an average of 44 days of abstinence at baseline.…
Peterson, Arthur V; Marek, Patrick M; Kealey, Kathleen A; Bricker, Jonathan B; Ludman, Evette J; Heffner, Jaimee L
2016-01-01
The Hutchinson Study of High School Smoking was the first randomized trial to show effectiveness of a smoking cessation intervention on 6-months prolonged smoking abstinence at one year post-intervention in a large population-based sample of adolescent smokers. An important question remains: Do the positive effects from teen smoking cessation interventions seen at up to 12 months post-intervention endure into young adulthood? This study examines for the first time whether such positive early effects from teen smoking cessation intervention can endure into young adulthood in the absence of additional intervention. High school smokers (n = 2,151) were proactively recruited into the trial from fifty randomly selected Washington State high schools randomized to the experimental (Motivational Interviewing + Cognitive Behavioral Skills Training telephone counseling intervention) or control (no intervention) condition. These smokers were followed to 7 years post high school to ascertain rates of six-year prolonged smoking abstinence in young adulthood. All statistical tests are two-sided. No evidence of intervention impact at seven years post high school was observed for the main endpoint of six-year prolonged abstinence, neither among all smokers (14.2% in the experimental condition vs. 13.1% in the control condition, difference = +1.1%, 95% confidence interval (CI) = -3.4 to 5.8, p = .61), nor among the subgroups of daily smokers and less-than-daily smokers, nor among other a priori subgroups. But, observed among males was some evidence of an intervention impact on two endpoints related to progress towards quitting: reduction in number of days smoked in the past month, and increase in the length of the longest quit attempt in the past year. There was no evidence from this trial among adolescent smokers that positive effectiveness of the proactive telephone intervention for smoking abstinence, observed previously at one year post-intervention, was sustained for the long
Milby, Jesse B; Conti, Kimberly; Wallace, Dennis; Mennemeyer, Stephen; Mrug, Sylvie; Schumacher, Joseph E
2015-02-01
We examined comorbid disorders' prevalence, their impact on abstinence, and the impact of depressive symptoms on abstinence and of abstinence on depressive symptoms. A randomized controlled trial's data on outcomes from treating cocaine dependence were used. It compared abstinence-contingent housing and work to contingency management plus behavioral day treatment. Regardless of original trial arm assignment, groups of participants with no additional Axis I disorders (n = 87) and 1 or more additional Axis I disorders (n = 113) were compared for abstinence. Changes in depression symptoms, measured by the Beck Depression Inventory, were analyzed as a function of 4 cohorts of increased consecutive weeks abstinent. An autoregressive cross-lagged path model examined reciprocal relationships between depression and abstinence. Most prevalent additional disorders were depressive disorders, followed by anxiety disorders. Additional disorders did not significantly affect abstinence. Cohorts with more abstinence were linearly related to lower depression symptoms. The cross-lagged model showed that longer abstinence predicted decreases in depressive symptoms at 6 months. However, depressive symptoms did not predict changes in abstinence. Our study adds to others that have found an effective treatment targeted at specific problems such as substance abuse, social anxiety disorder, and posttraumatic stress disorder that may have the side benefit of reducing depression. Additionally, we find that depression does not interfere with effective substance abuse treatment for cocaine dependency. This may be the 1st formal analysis comparing the ability of cocaine abstinence to predict future depressive symptoms versus depressive symptoms to predict future cocaine abstinence. (PsycINFO Database Record (c) 2015 APA, all rights reserved).
Garbutt, James C; Kampov-Polevoy, Alexei B; Gallop, Robert; Kalka-Juhl, Linda; Flannery, Barbara A.
2010-01-01
Background Recent clinical trials and case-reports indicate that baclofen, a GABAB agonist, may have efficacy for alcohol dependence. Baclofen has been shown to enhance abstinence, to reduce drinking quantity, to reduce craving, and to reduce anxiety in alcohol dependent individuals in two placebo-controlled trials in Italy. However, the clinical trial data with baclofen is limited. The purpose of the present study was to test the efficacy and tolerability of baclofen in alcohol dependence in the United States. Methods The study was a double-blind, placebo-controlled, randomized study comparing 30 mg per day of baclofen to placebo over 12 weeks of treatment and utilizing eight sessions of BRENDA, a low-intensity psychosocial intervention. 121 subjects were screened to yield 80 randomized subjects (44 male) with randomization balanced for gender. Percent heavy drinking days was the primary outcome measure with other drinking outcomes, anxiety levels, and craving as secondary outcomes. Tolerability was examined. Results 76% of subjects completed the study. No difference by drug condition was seen in % heavy drinking days where on-average rates were 25.5% (± 23.6%) for placebo and 25.9% (± 23.2%) for baclofen during treatment (t(73)=0.59, p=0.56). Similarly, no differences were seen by drug condition in % days abstinent, time to first drink, or time to relapse to heavy drinking. Baclofen was associated with a significant reduction in state anxiety (F(1,73)=5.39, p=0.02). Baclofen was well tolerated with only two individuals stopping baclofen because of adverse events. There were no serious adverse events. Conclusions Baclofen, a GABAB agonist, represents a possible new pharmacotherapeutic approach to alcohol dependence. Despite encouraging preclinical data and prior positive clinical trials with baclofen in Italy, the current trial did not find evidence that baclofen is superior to placebo in the treatment of alcohol dependence. Additional clinical trial work is
Bentzley, Jessica P.; Tomko, Rachel L.; Gray, Kevin M.
2016-01-01
Background In light of recent progress toward pharmacologic interventions to treat adolescent cannabis use disorder, it is important to consider which adolescent characteristics may be associated with a favorable response to treatment. This study presents secondary analyses from a parent randomized controlled trial of N-acetylcysteine (NAC) in adolescents with cannabis use disorder. We hypothesized high pretreatment impulsivity and medication non-adherence would be associated with reduced abstinence rates. Methods Participants were treatment-seeking adolescents (N = 115) who met criteria for cannabis use disorder and were assessed for pretreatment impulsivity. They received 1200 mg NAC or placebo orally twice daily for 8 weeks. An intent-to-treat analysis using a repeated-measures logistic regression model was used to relate pretreatment impulsivity (Barratt Impulsiveness Scale) and treatment group to abstinence rates, measured by urine cannabinoid tests. To explore mechanisms by which NAC may reduce cannabis use, relationships between impulsivity, adherence, and abstinence were assessed in a second statistical model using data from participants with recorded adherence and urine cannabinoid test results (n = 54). Results In the intent-to-treat analysis, low pretreatment impulsivity, NAC treatment, and negative baseline urine cannabinoid test results independently increased the odds of having negative urine cannabinoid tests during treatment (OR = 2.1, 2.3, 5.3 respectively). In the sample of participants with adherence data (n = 54), adherence tripled the odds of abstinence. Notably, the effect of adherence on abstinence was only observed in the NAC treatment group. Lastly, although the highly impulsive participants had reduced rates of abstinence, highly impulsive individuals adherent to NAC treatment had increased abstinence rates compared to non-adherent individuals. Conclusion Low impulsivity, NAC treatment, medication adherence, and baseline negative
An, Lawrence C; Demers, Michele R S; Kirch, Matthias A; Considine-Dunn, Shannon; Nair, Vijay; Dasgupta, Kohinoor; Narisetty, Naveen; Resnicow, Ken; Ahluwalia, Jasjit
2013-12-01
Young adulthood is a critical transition period for the development of health behaviors. We present here the results of a randomized controlled trial of an online avatar-hosted personal health makeover program designed for young adult smokers. We conducted a three-group randomized trial comparing delivery of general lifestyle content (Tx1), personally tailored health information (Tx2), and personally tailored health information plus online video-based peer coaching (Tx3) as part of a 6-week online health program. Participants were asked to set weekly goals around eating breakfast, exercise, alcohol use, and cigarette smoking. Eligibility criteria included age (18-30 years) and smoking status (any cigarette use in the previous 30 days). The primary outcome was self-reported 30-day abstinence measured 12 weeks postenrollment. Participant (n = 1698) characteristics were balanced across the groups (72% women, mean age 24, 26% nonwhite, 32% high school education or less, and 50% daily smokers). Considering intention to treat, 30-day smoking abstinence rates were statistically significantly higher in the intervention groups (Tx1 = 11%, Tx2 = 23%, Tx3 = 31%, P < .001). Participants in the intervention groups were also more likely to reduce their number of days spent on binge drinking and increase their number of days eating breakfast and exercising. Overall, intervention group participants were much more likely to make positive changes in at least three or four of the target behaviors (Tx1 = 19%, Tx2 = 39%, Tx3 = 41%, P < .001). This online avatar-hosted personal health makeover "show" increased smoking abstinence and induced positive changes in multiple related health behaviors. Addition of the online video-based peer coaching further improved behavioral outcomes.
Naughton, Felix; Cooper, Sue; Foster, Katharine; Emery, Joanne; Leonardi-Bee, Jo; Sutton, Stephen; Jones, Matthew; Ussher, Michael; Whitemore, Rachel; Leighton, Matthew; Montgomery, Alan; Parrott, Steve; Coleman, Tim
2017-07-01
To estimate the effectiveness of pregnancy smoking cessation support delivered by short message service (SMS) text message and key parameters needed to plan a definitive trial. Multi-centre, parallel-group, single-blinded, individual randomized controlled trial. Sixteen antenatal clinics in England. Four hundred and seven participants were randomized to the intervention (n = 203) or usual care (n = 204). Eligible women were < 25 weeks gestation, smoked at least one daily cigarette (> 5 pre-pregnancy), were able to receive and understand English SMS texts and were not already using text-based cessation support. All participants received a smoking cessation leaflet; intervention participants also received a 12-week programme of individually tailored, automated, interactive, self-help smoking cessation text messages (MiQuit). Seven smoking outcomes, including validated continuous abstinence from 4 weeks post-randomization until 36 weeks gestation, design parameters for a future trial and cost-per-quitter. Using the validated, continuous abstinence outcome, 5.4% (11 of 203) of MiQuit participants were abstinent versus 2.0% (four of 204) of usual care participants [odds ratio (OR) = 2.7, 95% confidence interval (CI) = 0.93-9.35]. The Bayes factor for this outcome was 2.23. Completeness of follow-up at 36 weeks gestation was similar in both groups; provision of self-report smoking data was 64% (MiQuit) and 65% (usual care) and abstinence validation rates were 56% (MiQuit) and 61% (usual care). The incremental cost-per-quitter was £133.53 (95% CI = -£395.78 to 843.62). There was some evidence, although not conclusive, that a text-messaging programme may increase cessation rates in pregnant smokers when provided alongside routine NHS cessation care. © 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.
Díaz-Gete, Laura; Puigdomènech, Elisa; Briones, Elena Mercedes; Fàbregas-Escurriola, Mireia; Fernandez, Soraya; Del Val, Jose Luis; Ballvé, Jose Luis; Casajuana, Marc; Sánchez-Fondevila, Jessica; Clemente, Lourdes; Castaño, Carmen; Martín-Cantera, Carlos
2013-04-18
Intensive interventions on smoking cessation increase abstinence rates. However, few electronic mail (E-mail) based intensive interventions have been tested in smokers and none in primary care (PC) setting. The aim of the present study is to evaluate the effectiveness of an intensive E-mail based intervention in smokers attending PC services. Randomized Controlled Multicentric Trial. 1060 smokers aged between 18-70 years from Catalonia, Salamanca and Aragón (Spain) who have and check regularly an E-mail account. Patients will be randomly assigned to control or intervention group. Six phase intensive intervention with two face to face interviews and four automatically created and personal E-mail patients tracking, if needed other E-mail contacts will be made. Control group will receive a brief advice on smoking cessation. Will be measured at 6 and 12 months after intervention: self reported continuous abstinence (confirmed by cooximetry), point prevalence abstinence, tobacco consumption, evolution of stage according to Prochaska and DiClemente's Stages of Change Model, length of visit, costs for the patient to access Primary Care Center. Descriptive and logistic and Poisson regression analysis under the intention to treat basis using SPSS v.17. The proposed intervention is an E-mail based intensive intervention in smokers attending primary care. Positive results could be useful to demonstrate a higher percentage of short and long-term abstinence among smokers attended in PC in Spain who regularly use E-mail. Furthermore, this intervention could be helpful in all health services to help smokers to quit. Clinical Trials.gov Identifier: NCT01494246.
Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention.
Brendryen, Håvar; Kraft, Pål
2008-03-01
To assess the long-term efficacy of a fully automated digital multi-media smoking cessation intervention. Two-arm randomized control trial (RCT). Setting World Wide Web (WWW) study based in Norway. Subjects (n = 396) were recruited via internet advertisements and assigned randomly to conditions. Inclusion criteria were willingness to quit smoking and being aged 18 years or older. The treatment group received the internet- and cell-phone-based Happy Ending intervention. The intervention programme lasted 54 weeks and consisted of more than 400 contacts by e-mail, web-pages, interactive voice response (IVR) and short message service (SMS) technology. The control group received a self-help booklet. Additionally, both groups were offered free nicotine replacement therapy (NRT). Abstinence was defined as 'not even a puff of smoke, for the last 7 days', and assessed by means of internet surveys or telephone interviews. The main outcome was repeated point abstinence at 1, 3, 6 and 12 months following cessation. Participants in the treatment group reported clinically and statistically significantly higher repeated point abstinence rates than control participants [22.3% versus 13.1%; odds ratio (OR) = 1.91, 95% confidence interval (CI): 1.12-3.26, P = 0.02; intent-to-treat). Improved adherence to NRT and a higher level of post-cessation self-efficacy were observed in the treatment group compared with the control group. As the first RCT documenting the long-term treatment effects of such an intervention, this study adds to the promise of digital media in supporting behaviour change.
Buller, David B; Borland, Ron; Bettinghaus, Erwin P; Shane, James H; Zimmerman, Donald E
2014-03-01
Text messaging has successfully supported smoking cessation. This study compares a mobile application with text messaging to support smoking cessation. Young adult smokers 18-30 years old (n = 102) participated in a randomized pretest-posttest trial. Smokers received a smartphone application (REQ-Mobile) with short messages and interactive tools or a text messaging system (onQ), managed by an expert system. Self-reported usability of REQ-Mobile and quitting behavior (quit attempts, point-prevalence, 30-day point-prevalence, and continued abstinence) were assessed in posttests. Overall, 60% of smokers used mobile services (REQ-Mobile, 61%, mean of 128.5 messages received; onQ, 59%, mean of 107.8 messages), and 75% evaluated REQ-Mobile as user-friendly. A majority of smokers reported being abstinent at posttest (6 weeks, 53% of completers; 12 weeks, 66% of completers [44% of all cases]). Also, 37% (25%of all cases) reported 30-day point-prevalence abstinence, and 32% (22% of all cases) reported continuous abstinence at 12 weeks. OnQ produced more abstinence (p<0.05) than REQ-Mobile. Use of both services predicted increased 30-day abstinence at 12 weeks (used, 47%; not used, 20%; p = 0.03). REQ-Mobile was feasible for delivering cessation support but appeared to not move smokers to quit as quickly as text messaging. Text messaging may work better because it is simple, well known, and delivered to a primary inbox. These advantages may disappear as smokers become more experienced with new handsets. Mobile phones may be promising delivery platforms for cessation services using either smartphone applications or text messaging.
The role of prepartum motivation in the maintenance of postpartum smoking abstinence
Heppner, Whitney L.; Ji, Lingyun; Reitzel, Lorraine R.; Castro, Yessenia; Correa-Fernandez, Virmarie; Vidrine, Jennifer Irvin; Li, Yisheng; Dolan-Mullen, Patricia; Velasquez, Mary M.; Cinciripini, Paul M.; Cofta-Woerpel, Ludmila; Greisinger, Anthony; Wetter, David W.
2011-01-01
Objective Motivation plays an important role in a variety of behaviors, including smoking cessation, and is integral to theory and treatment of smoking. For many women, pregnancy offers a motivational shift that helps them stop smoking and maintain abstinence during pregnancy. However, women's motivation to maintain smoking abstinence postpartum is not well-understood and may play a role in high postpartum relapse rates. The current study utilized multiple measures of prepartum motivation to maintain smoking abstinence to predict postpartum smoking abstinence. Design As part of a randomized clinical trial on postpartum smoking relapse prevention, pregnant women who quit smoking during pregnancy reported their motivation to continue smoking abstinence at a prepartum baseline session. Continued smoking abstinence was assessed at 8 and 26 weeks postpartum. Main Outcome Measure Biochemically verified continuous abstinence from smoking. Results Direct relationships among multiple measures of motivation were significant, and ranged in strength from weak to moderate. All motivation measures individually predicted continuous smoking abstinence, after controlling for treatment group, demographics, and pre-quit tobacco use. When tested simultaneously, a global motivation measure and parenthood motives for quitting remained significant predictors of abstinence. Backward selection modeling procedures resulted in a reduced model of prepartum predictors of postpartum abstinence including global motivation, parenthood motives, and stage of change. Conclusion Global motivation for smoking abstinence and parenthood motives for quitting are particularly important motivational constructs for pregnant women's continued smoking abstinence. PMID:21859215
2011-01-01
Background Smoking is the world's fourth most common risk factor for disease, the leading preventable cause of death, and it is associated with tremendous social costs. In the Netherlands, the smoking prevalence rate is high. A total of 27.7% of the population over age 15 years smokes. In addition to the direct advantages of smoking cessation for the smoker, parents who quit smoking may also decrease their children's risk of smoking initiation. Methods/Design A randomized controlled trial will be conducted to evaluate the effectiveness of proactive telephone counselling to increase smoking cessation rates among smoking parents. A total of 512 smoking parents will be proactively recruited through their children's primary schools and randomly assigned to either proactive telephone counselling or a control condition. Proactive telephone counselling will consist of up to seven counsellor-initiated telephone calls (based on cognitive-behavioural skill building and Motivational Interviewing), distributed over a period of three months. Three supplementary brochures will also be provided. In the control condition, parents will receive a standard brochure to aid smoking cessation. Assessments will take place at baseline, three months after start of the intervention (post-measurement), and twelve months after start of the intervention (follow-up measurement). Primary outcome measures will include sustained abstinence between post-measurement and follow-up measurement and 7-day point prevalence abstinence and 24-hours point prevalence abstinence at both post- and follow-up measurement. Several secondary outcome measures will also be included (e.g., smoking intensity, smoking policies at home). In addition, we will evaluate smoking-related cognitions (e.g., attitudes towards smoking, social norms, self-efficacy, intention to smoke) in 9-12 year old children of smoking parents. Discussion This study protocol describes the design of a randomized controlled trial to evaluate the
McCollister, Kathryn E; French, Michael T; Freitas, Derek M; Dennis, Michael L; Scott, Christy K; Funk, Rodney R
2013-12-01
This study performs the first cost-effectiveness analysis (CEA) of Recovery Management Checkups (RMC) for adults with chronic substance use disorders. Cost-effectiveness analysis of a randomized clinical trial of RMC. Participants were assigned randomly to a control condition of outcome monitoring (OM-only) or the experimental condition OM-plus-RMC, with quarterly follow-up for 4 years. Participants were recruited from the largest central intake unit for substance abuse treatment in Chicago, Illinois, USA. A total of 446 participants who were 38 years old on average, 54% male, and predominantly African American (85%). Data on the quarterly cost per participant come from a previous study of OM and RMC intervention costs. Effectiveness is measured as the number of days of abstinence and number of substance use-related problems. Over the 4-year trial, OM-plus-RMC cost on average $2184 more than OM-only (P < 0.01). Participants in OM-plus-RMC averaged 1026 days abstinent and had 89 substance use-related problems. OM-only averaged 932 days abstinent and reported 126 substance use-related problems. Mean differences for both effectiveness measures were statistically significant (P < 0.01). The incremental cost-effectiveness ratio for OM-plus-RMC was $23.38 per day abstinent and $59.51 per reduced substance-related problem. When additional costs to society were factored into the analysis, OM-plus-RMC was less costly and more effective than OM-only. Recovery Management Checkups are a cost-effective and potentially cost-saving strategy for promoting abstinence and reducing substance use-related problems among chronic substance users. © 2013 Society for the Study of Addiction.
McCollister, Kathryn E.; French, Michael T.; Freitas, Derek M.; Dennis, Michael L.; Scott, Christy K.; Funk, Rodney R.
2013-01-01
Aims This study performs the first cost-effectiveness analysis (CEA) of Recovery Management Checkups (RMC) for adults with chronic substance use disorders. Design Cost-effectiveness analysis of a randomized clinical trial of RMC. Participants were randomly assigned to a control condition of outcome monitoring (OM-only) or the experimental condition OM-plus-RMC, with quarterly follow-up for four years. Setting Participants were recruited from the largest central intake unit for substance abuse treatment in Chicago, Illinois, USA. Participants 446 participants who were 38 years old on average, 54 percent male, and predominantly African American (85%). Measurements Data on the quarterly cost per participant come from a previous study of OM and RMC intervention costs. Effectiveness is measured as the number of days of abstinence and number of substance-use-related problems. Findings Over the four-year trial, OM-plus-RMC cost on average $2,184 more than OM-only (p<0.01). Participants in OM-plus-RMC averaged 1,026 days abstinent and had 89 substance-use-related problems. OM-only averaged 932 days abstinent and reported 126 substance-use-related problems. Mean differences for both effectiveness measures were statistically significant (p<0.01). The incremental cost-effectiveness ratio for OM-plus-RMC was $23.38 per day abstinent and $59.51 per reduced substance-related problem. When additional costs to society were factored into the analysis, OM-plus-RMC was less costly and more effective than OM-only. Conclusions Recovery Management Checkups are a cost-effective and potentially cost-saving strategy for promoting abstinence and reducing substance-use-related problems among chronic substance users. PMID:23961833
Winhusen, Theresa M; Brigham, Gregory S; Kropp, Frankie; Lindblad, Robert; Gardin, John G; Penn, Pat; Hodgkins, Candace; Kelly, Thomas M; Douaihy, Antoine; McCann, Michael; Love, Lee D; DeGravelles, Eliot; Bachrach, Ken; Sonne, Susan C; Hiott, Bob; Haynes, Louise; Sharma, Gaurav; Lewis, Daniel F; VanVeldhuisen, Paul; Theobald, Jeff; Ghitza, Udi
2014-04-01
To evaluate the impact of concurrent treatments for substance use disorder and nicotine-dependence for stimulant-dependent patients. A randomized, 10-week trial with follow-up at 3 and 6 months after smoking quit date conducted at 12 substance use disorder treatment programs between February 2010 and July 2012. Adults meeting DSM-IV-TR criteria for cocaine and/or methamphetamine dependence and interested in quitting smoking were randomized to treatment as usual (n = 271) or treatment as usual with smoking-cessation treatment (n = 267). All participants received treatment as usual for substance use disorder treatment. Participants assigned to treatment as usual with concurrent smoking-cessation treatment received weekly individual smoking cessation counseling and extended-release bupropion (300 mg/d) during weeks 1-10. During post-quit treatment (weeks 4-10), participants assigned to treatment as usual with smoking-cessation treatment received a nicotine inhaler and contingency management for smoking abstinence. Weekly proportion of stimulant-abstinent participants during the treatment phase, as assessed by urine drug screens and self-report, was the primary outcome. Secondary measures included other substance/nicotine use outcomes and treatment attendance. There were no significant treatment effects on stimulant-use outcomes, as measured by the primary outcome and stimulant-free days, on drug-abstinence, or on attendance. Participants assigned to treatment as usual with smoking-cessation treatment, relative to those assigned to treatment as usual, had significantly better outcomes for drug-free days at 6-month follow-up (χ(2)(1) = 4.09, P <.05), with a decrease in drug-free days from baseline of -1.3% in treatment as usual with smoking-cessation treatment and of -7.6% in treatment as usual. Participants receiving treatment as usual with smoking-cessation treatment, relative to those receiving treatment as usual, had significantly better outcomes on smoking point
Borland, Ron; Balmford, James; Benda, Peter
2013-03-01
To test the population impact of offering automated smoking cessation interventions via the internet and/or by mobile phone. Pragmatic randomized controlled trial with five conditions: offer of (i) minimal intervention control; (ii) QuitCoach personalized tailored internet-delivered advice program; (iii) onQ, an interactive automated text-messaging program; (iv) an integration of both QuitCoach and onQ; and (v) a choice of either alone or the combined program. Australia, via a mix of internet and telephone contacts. A total of 3530 smokers or recent quitters recruited from those interested in quitting, and seeking self-help resources (n = 1335) or cold-contacted from internet panels (n = 2195). The primary outcome was self-report of 6 months sustained abstinence at 7 months post-recruitment. Only 42.5% of those offered one of the interventions took it up to a minimal level. The intervention groups combined had a non-significantly higher 6-month sustained abstinence rate than the control [odds ratio (OR) = 1.48; 95% confidence interval (CI): 0.98-2.24] (missing cases treated as smokers), with no differences between the interventions. Among those who used an intervention, there was a significant overall increase in abstinence (OR = 1.95; CI: 1.04-3.67), but not clearly so when analysing only cases with reported outcomes. Success rates were greater among those recruited after seeking information compared to those cold-contacted. Smokers interested in quitting who were assigned randomly to an offer of either the QuitCoach internet-based support program and/or the interactive automated text-messaging program had non-significantly greater odds of quitting for at least 6 months than those randomized to an offer of a simple information website. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.
Blanken, Peter; Hendriks, Vincent M; Huijsman, Ineke A; van Ree, Jan M; van den Brink, Wim
2016-07-01
To determine the efficacy of contingency management (CM), targeting cocaine use, as an add-on intervention for heroin dependent patients in supervised heroin-assisted treatment (HAT) with frequent cocaine use. Multi-center, open-label, parallel group, randomized controlled trial. Twelve specialized addiction treatment centers for HAT in The Netherlands; April 2006-January 2011. 214 chronic, treatment-refractory heroin dependent patients in HAT, with frequent cocaine use. Routine, daily supervised diacetylmorphine treatment, co-prescribed with oral methadone (HAT), with and without 6 months contingency management for cocaine use as an add-on intervention; HAT+CM and HAT-only, respectively. Primary outcome was the longest, uninterrupted duration of cocaine abstinence, based upon laboratory urinalysis. Secondary outcome measures included other cocaine-related measures, treatment retention in HAT, and multi-domain health-related treatment response. In an intention-to-treat analysis, HAT+CM was more effective than HAT-only in promoting longer, uninterrupted duration of cocaine abstinence (3.7 weeks versus 1.6 weeks; negative binomial regression: Exp(B)=2.34, 95%-CI: 1.70-3.23; p<0.001). This result remained significant in sensitivity analyses and was supported by all secondary, cocaine-related outcome measures. Treatment retention in HAT was high (91.6%) with no difference between the groups. The improvement in multi-domain health-related treatment response during the trial was numerically higher in HAT+CM (from 37.4% to 53.1%; +15.7%) than in HAT-only (from 44.5% to 46.5%; +2.0%), but this difference was statistically not significant. Contingency management is an effective add-on intervention to promote longer, uninterrupted periods of cocaine abstinence in chronic, treatment-refractory heroin dependent patients in heroin-assisted treatment with frequent cocaine use. The trial has been registered in The Netherlands National Trial Register under clinical trial
Group-Based Randomized Trial of Contingencies for Health and Abstinence in HIV Patients
ERIC Educational Resources Information Center
Petry, Nancy M.; Weinstock, Jeremiah; Alessi, Sheila M.; Lewis, Marilyn W.; Dieckhaus, Kevin
2010-01-01
Objective: Contingency management (CM) treatments are usually applied individually for drug abstinence, but CM can also be targeted toward health behaviors and implemented in groups. This study evaluated effects of a group-based CM intervention that focused on reinforcing health behaviors. Method: HIV-positive patients with cocaine or opioid use…
A Randomized Trial of an Avatar-Hosted Multiple Behavior Change Intervention for Young Adult Smokers
2013-01-01
Background Young adulthood is a critical transition period for the development of health behaviors. We present here the results of a randomized controlled trial of an online avatar-hosted personal health makeover program designed for young adult smokers. Methods We conducted a three-group randomized trial comparing delivery of general lifestyle content (Tx1), personally tailored health information (Tx2), and personally tailored health information plus online video–based peer coaching (Tx3) as part of a 6-week online health program. Participants were asked to set weekly goals around eating breakfast, exercise, alcohol use, and cigarette smoking. Eligibility criteria included age (18–30 years) and smoking status (any cigarette use in the previous 30 days). The primary outcome was self-reported 30-day abstinence measured 12 weeks postenrollment. Results Participant (n = 1698) characteristics were balanced across the groups (72% women, mean age 24, 26% nonwhite, 32% high school education or less, and 50% daily smokers). Considering intention to treat, 30-day smoking abstinence rates were statistically significantly higher in the intervention groups (Tx1 = 11%, Tx2 = 23%, Tx3 = 31%, P < .001). Participants in the intervention groups were also more likely to reduce their number of days spent on binge drinking and increase their number of days eating breakfast and exercising. Overall, intervention group participants were much more likely to make positive changes in at least three or four of the target behaviors (Tx1 = 19%, Tx2 = 39%, Tx3 = 41%, P < .001). Conclusions This online avatar-hosted personal health makeover “show” increased smoking abstinence and induced positive changes in multiple related health behaviors. Addition of the online video–based peer coaching further improved behavioral outcomes. PMID:24395994
A randomized placebo-controlled trial of N-acetylcysteine for cannabis use disorder in adults.
Gray, Kevin M; Sonne, Susan C; McClure, Erin A; Ghitza, Udi E; Matthews, Abigail G; McRae-Clark, Aimee L; Carroll, Kathleen M; Potter, Jennifer S; Wiest, Katharina; Mooney, Larissa J; Hasson, Albert; Walsh, Sharon L; Lofwall, Michelle R; Babalonis, Shanna; Lindblad, Robert W; Sparenborg, Steven; Wahle, Aimee; King, Jacqueline S; Baker, Nathaniel L; Tomko, Rachel L; Haynes, Louise F; Vandrey, Ryan G; Levin, Frances R
2017-08-01
Cannabis use disorder (CUD) is a prevalent and impairing condition, and established psychosocial treatments convey limited efficacy. In light of recent findings supporting the efficacy of N-acetylcysteine (NAC) for CUD in adolescents, the objective of this trial was to evaluate its efficacy in adults. In a 12-week double-blind randomized placebo-controlled trial, treatment-seeking adults ages 18-50 with CUD (N=302), enrolled across six National Drug Abuse Treatment Clinical Trials Network-affiliated clinical sites, were randomized in a 1:1 ratio to a 12-week course of NAC 1200mg (n=153) or placebo (n=149) twice daily. All participants received contingency management (CM) and medical management. The primary efficacy measure was the odds of negative urine cannabinoid tests during treatment, compared between NAC and placebo participants. There was not statistically significant evidence that the NAC and placebo groups differed in cannabis abstinence (odds ratio=1.00, 95% confidence interval 0.63-1.59, p=0.984). Overall, 22.3% of urine cannabinoid tests in the NAC group were negative, compared with 22.4% in the placebo group. Many participants were medication non-adherent; exploratory analysis within medication-adherent subgroups revealed no significant differential abstinence outcomes by treatment group. In contrast with prior findings in adolescents, there is no evidence that NAC 1200mg twice daily plus CM is differentially efficacious for CUD in adults when compared to placebo plus CM. This discrepant finding between adolescents and adults with CUD may have been influenced by differences in development, cannabis use profiles, responses to embedded behavioral treatment, medication adherence, and other factors. Copyright © 2017 Elsevier B.V. All rights reserved.
Cheung, Yee Tak Derek; Leung, Jessica Pui Kei; Cheung, Chelsia Ka Ching; Li, William Ho Cheung; Wang, Man Ping; Lam, Tai Hing
2016-07-26
About half of the daily smokers in Hong Kong have never tried and have no intention to quit smoking. More than one-third (37.9 %) of daily smokers have attempted to quit but failed. Nicotine replacement therapy (NRT) is a safe and effective pharmacotherapy to increase abstinence by reducing withdrawal symptoms during the early stage of smoking abstinence. However, the prevalence of NRT use in Hong Kong is lower than in most developed countries. The proposed study aims to assess the effectiveness of providing free NRT samples to smokers on increasing quit attempts and the quit rate. Trained university undergraduate students as ambassadors will invite smokers at outdoor public smoking hotspots to participate in the randomized controlled trial, in which eligible smokers will be randomized to receive a 1-week free NRT sample and medication counselling (intervention) or advice to purchase NRT on their own (control). The primary outcome is self-reported quit attempts (no smoking for at least 24 hours) in the past 30 days at 1-month and 3-month telephone follow-up. The findings will inform the effectiveness of delivering free NRT samples at outdoor public smoking hotspots to increase quit attempts and abstinence. The study will also provide information on smokers' adherence to the NRT sample, side effects and safety issues related to the usage. This will improve the design of a large trial to test the effect of the NRT sample. ClinicalTrials.gov NCT02491086 . Registered on 7 July 2015.
Borland, Ron; Bettinghaus, Erwin P.; Shane, James H.; Zimmerman, Donald E.
2014-01-01
Abstract Background: Text messaging has successfully supported smoking cessation. This study compares a mobile application with text messaging to support smoking cessation. Materials and Methods: Young adult smokers 18–30 years old (n=102) participated in a randomized pretest–posttest trial. Smokers received a smartphone application (REQ-Mobile) with short messages and interactive tools or a text messaging system (onQ), managed by an expert system. Self-reported usability of REQ-Mobile and quitting behavior (quit attempts, point-prevalence, 30-day point-prevalence, and continued abstinence) were assessed in posttests. Results: Overall, 60% of smokers used mobile services (REQ-Mobile, 61%, mean of 128.5 messages received; onQ, 59%, mean of 107.8 messages), and 75% evaluated REQ-Mobile as user-friendly. A majority of smokers reported being abstinent at posttest (6 weeks, 53% of completers; 12 weeks, 66% of completers [44% of all cases]). Also, 37% (25%of all cases) reported 30-day point-prevalence abstinence, and 32% (22% of all cases) reported continuous abstinence at 12 weeks. OnQ produced more abstinence (p<0.05) than REQ-Mobile. Use of both services predicted increased 30-day abstinence at 12 weeks (used, 47%; not used, 20%; p=0.03). Conclusions: REQ-Mobile was feasible for delivering cessation support but appeared to not move smokers to quit as quickly as text messaging. Text messaging may work better because it is simple, well known, and delivered to a primary inbox. These advantages may disappear as smokers become more experienced with new handsets. Mobile phones may be promising delivery platforms for cessation services using either smartphone applications or text messaging. PMID:24350804
Preventing smoking relapse via Web-based computer-tailored feedback: a randomized controlled trial.
Elfeddali, Iman; Bolman, Catherine; Candel, Math J J M; Wiers, Reinout W; de Vries, Hein
2012-08-20
Web-based computer-tailored approaches have the potential to be successful in supporting smoking cessation. However, the potential effects of such approaches for relapse prevention and the value of incorporating action planning strategies to effectively prevent smoking relapse have not been fully explored. The Stay Quit for You (SQ4U) study compared two Web-based computer-tailored smoking relapse prevention programs with different types of planning strategies versus a control group. To assess the efficacy of two Web-based computer-tailored programs in preventing smoking relapse compared with a control group. The action planning (AP) program provided tailored feedback at baseline and invited respondents to do 6 preparatory and coping planning assignments (the first 3 assignments prior to quit date and the final 3 assignments after quit date). The action planning plus (AP+) program was an extended version of the AP program that also provided tailored feedback at 11 time points after the quit attempt. Respondents in the control group only filled out questionnaires. The study also assessed possible dose-response relationships between abstinence and adherence to the programs. The study was a randomized controlled trial with three conditions: the control group, the AP program, and the AP+ program. Respondents were daily smokers (N = 2031), aged 18 to 65 years, who were motivated and willing to quit smoking within 1 month. The primary outcome was self-reported continued abstinence 12 months after baseline. Logistic regression analyses were conducted using three samples: (1) all respondents as randomly assigned, (2) a modified sample that excluded respondents who did not make a quit attempt in conformance with the program protocol, and (3) a minimum dose sample that also excluded respondents who did not adhere to at least one of the intervention elements. Observed case analyses and conservative analyses were conducted. In the observed case analysis of the randomized sample
Winhusen, Theresa; Wilder, Christine; Wexelblatt, Scott L; Theobald, Jeffrey; Hall, Eric S; Lewis, Daniel; Van Hook, James; Marcotte, Michael
2014-09-01
In recent years, the U.S. has experienced a significant increase in the prevalence of pregnant opioid-dependent women and of neonatal abstinence syndrome (NAS), which is caused by withdrawal from in-utero drug exposure. While methadone-maintenance currently is the standard of care for opioid dependence during pregnancy, research suggests that buprenorphine-maintenance may be associated with shorter infant hospital lengths of stay (LOS) relative to methadone-maintenance. There is no "gold standard" treatment for NAS but there is evidence that buprenorphine, relative to morphine or methadone, treatment may reduce LOS and length of treatment. Point-of-care clinical trial (POCCT) designs, maximizing external validity while reducing cost and complexity associated with classic randomized clinical trials, were selected for two planned trials to compare methadone to buprenorphine treatment for opioid dependence during pregnancy and for NAS. This paper describes design considerations for the Medication-assisted treatment for Opioid-dependent expecting Mothers (MOMs; estimated N = 370) and Investigation of Narcotics for Ameliorating Neonatal abstinence syndrome on Time in hospital (INFANTs; estimated N = 284) POCCTs, both of which are randomized, intent-to-treat, two-group trials. Outcomes would be obtained from participants' electronic health record at three participating hospitals. Additionally, a subset of infants in the INFANTs POCCT would be from mothers in the MOMs POCCT and, thus, potential interaction between medication treatment of mother and infant could be evaluated. This pair of planned POCCTs would evaluate the comparative effectiveness of treatments for opioid dependence during pregnancy and for NAS. The results could have a significant impact on practice. Copyright © 2014 Elsevier Inc. All rights reserved.
Smoking topography and abstinence in adult female smokers
McClure, Erin A.; Saladin, Michael E.; Baker, Nathaniel L.; Carpenter, Matthew J.; Gray, Kevin M.
2013-01-01
Preliminary evidence, within both adults and adolescents, suggests that the intensity with which cigarettes are smoked (i.e. smoking topography) is predictive of success during a cessation attempt. These reports have also shown topography to be superior compared to other variables, such as cigarettes per day, in the prediction of abstinence. The possibility that gender may influence this predictive relationship has not been evaluated, but may be clinically useful in tailoring gender-specific interventions. Within the context of a clinical trial for smoking cessation among women, adult daily smokers completed a laboratory session that included a 1-hour ad-libitum smoking period in which measures of topography were collected (N=135). Participants were then randomized to active medication (nicotine patch vs. varenicline) and abstinence was monitored for 4 weeks. Among all smoking topography measures and all abstinence outcomes, a moderate association was found between longer puff duration and greater puff volume and continued smoking during the active 4-week treatment phase, but only within the nicotine patch group. Based on the weak topography-abstinence relationship among female smokers found in the current study, future studies should focus on explicit gender comparisons to examine if these associations are specific to or more robust in male smokers. PMID:24018226
Smoking topography and abstinence in adult female smokers.
McClure, Erin A; Saladin, Michael E; Baker, Nathaniel L; Carpenter, Matthew J; Gray, Kevin M
2013-12-01
Preliminary evidence, within both adults and adolescents, suggests that the intensity with which cigarettes are smoked (i.e., smoking topography) is predictive of success during a cessation attempt. These reports have also shown topography to be superior compared to other variables, such as cigarettes per day, in the prediction of abstinence. The possibility that gender may influence this predictive relationship has not been evaluated but may be clinically useful in tailoring gender-specific interventions. Within the context of a clinical trial for smoking cessation among women, adult daily smokers completed a laboratory session that included a 1-hour ad libitum smoking period in which measures of topography were collected (N=135). Participants were then randomized to active medication (nicotine patch vs. varenicline) and abstinence was monitored for 4weeks. Among all smoking topography measures and all abstinence outcomes, a moderate association was found between longer puff duration and greater puff volume and continued smoking during the active 4-week treatment phase, but only within the nicotine patch group. Based on the weak topography-abstinence relationship among female smokers found in the current study, future studies should focus on explicit gender comparisons to examine if these associations are specific to or more robust in male smokers. © 2013 Elsevier Ltd. All rights reserved.
Motivation and patch treatment for HIV+ smokers: a randomized controlled trial.
Lloyd-Richardson, Elizabeth E; Stanton, Cassandra A; Papandonatos, George D; Shadel, William G; Stein, Michael; Tashima, Karen; Flanigan, Timothy; Morrow, Kathleen; Neighbors, Charles; Niaura, Raymond
2009-11-01
To test the efficacy of two smoking cessation interventions in a HIV positive (HIV+) sample: standard care (SC) treatment plus nicotine replacement therapy (NRT) versus more intensive motivationally enhanced (ME) treatment plus NRT. Randomized controlled trial. HIV+ smoker referrals from eight immunology clinics in the northeastern United States. A total of 444 participants enrolled in the study (mean age = 42.07 years; 63.28% male; 51.80% European American; mean cigarettes/day = 18.27). SC participants received two brief sessions with a health educator. Those setting a quit date received self-help quitting materials and NRT. ME participants received four sessions of motivational counseling and a quit-day counseling call. All ME intervention materials were tailored to the needs of HIV+ individuals. Biochemically verified 7-day abstinence rates at 2-month, 4-month and 6-month follow-ups. Intent-to-treat (ITT) abstinence rates at 2-month, 4-month and 6-month follow-ups were 12%, 9% and 9%, respectively, in the ME condition, and 13%, 10% and 10%, respectively, in the SC condition, indicating no between-group differences. Among 412 participants with treatment utilization data, 6-month ITT abstinence rates were associated positively with low nicotine dependence (P = 0.02), high motivation to quit (P = 0.04) and Hispanic American race/ethnicity (P = 0.02). Adjusting for these variables, each additional NRT contact improved the odds of smoking abstinence by a third (odds ratio = 1.32, 95% confidence interval = 0.99-1.75). Motivationally enhanced treatment plus NRT did not improve cessation rates over and above standard care treatment plus NRT in this HIV+ sample of smokers. Providers offering brief support and encouraging use of nicotine replacement may be able to help HIV+ patients to quit smoking.
Bupropion for Smoking Cessation in African American Light Smokers: A Randomized Controlled Trial
Nollen, Nicole L.; Mayo, Matthew S.; Choi, Won S.; Faseru, Babalola; Benowitz, Neal L.; Tyndale, Rachel F.; Okuyemi, Kolawole S.; Ahluwalia, Jasjit S.
2012-01-01
Background Previous research demonstrated the efficacy of sustained release bupropion (bupropion SR) for smoking cessation in whites as well as moderate to heavy (≥10 cigarettes per day [CPD]) African American smokers. We evaluated whether bupropion SR was effective for smoking cessation among African American light smokers (≤10 CPD). Methods A randomized, double-blind placebo-controlled trial was conducted from December 27, 2007, to May 13, 2010. All participants were African American light smokers (≤10 CPD), aged 18 years or older. Participants were randomly assigned to receive 300 mg bupropion SR (150 mg once daily for 3 days and then 150 mg twice daily) (n = 270 participants) or placebo (n = 270 participants) for 7 weeks, and up to six sessions of health education counseling. Serum cotinine was measured at baseline (week 0). The primary outcome was salivary cotinine–verified 7-day point prevalence smoking abstinence at week 26; a cut point of 15 ng/mL differentiated smokers from nonsmokers. Salivary cotinine–verified smoking abstinence at end of medication treatment at week 7 was also examined. Odds ratios (OR) for smoking abstinence and 95% confidence intervals (CIs) were calculated using logistic regression models. All statistical tests were two-sided. Results Participants at baseline visit (week 0) smoked an average of 8.0 CPD and had a mean serum cotinine level of 275.8 ng/mL (SD = 155.8 ng/mL); most used menthol cigarettes (83.7%) and smoked within 30 minutes of waking (72.2%). After imputing those lost to follow-up as smokers, no statistically significant difference in long-term smoking abstinence rates at week 26 was observed between bupropion SR and placebo groups (13.3% vs 10.0%, OR = 1.39, 95% CI = 0.82 to 2.35, P = .23). Cotinine-verified smoking abstinence rate at end of medication week 7 was higher in the bupropion SR vs placebo group (23.7% vs 9.6%, OR = 2.92, 95% CI = 1.78 to 4.77, P < .001). Conclusions Bupropion SR was effective in
Winhusen, Theresa M; Somoza, Eugene C; Brigham, Gregory S; Liu, David S; Green, Carla A; Covey, Lirio S; Croghan, Ivana T; Adler, Lenard A; Weiss, Roger D; Leimberger, Jeffrey D; Lewis, Daniel F; Dorer, Emily M
2010-12-01
High smoking rates in adults with attention-deficit/hyperactivity disorder (ADHD) and nicotine's amelioration of ADHD suggest that effective ADHD treatment might facilitate abstinence in smokers with ADHD. The present study evaluated if using osmotic-release oral system methylphenidate (OROS-MPH) to treat ADHD enhances response to smoking cessation treatment in smokers with ADHD. A randomized, double-blind, placebo-controlled, 11-week trial with a 1-month follow-up was conducted at 6 clinical sites between December 2005 and January 2008. Adults (aged 18-55 years) meeting DSM-IV criteria for ADHD and interested in quitting smoking were randomly assigned to OROS-MPH titrated to 72 mg/d (n = 127) or placebo (n = 128). All participants received brief weekly individual smoking cessation counseling for 11 weeks and 21 mg/d nicotine patches starting on the smoking quit day (day 27) through study week 11. Outcome measures included prolonged smoking abstinence and DSM-IV ADHD Rating Scale (ADHD-RS) score. Of 255 randomly assigned participants, 204 (80%) completed the trial. Prolonged abstinence rates, 43.3% and 42.2%, for the OROS-MPH and placebo groups, respectively, did not differ significantly (OR = 1.1; 95% CI, 0.63-1.79; P = .81). Relative to placebo, OROS-MPH evidenced a greater reduction in DSM-IV ADHD-RS score (P < .0001) and in cigarettes per day during the post-quit phase (P = .016). Relative to placebo, OROS-MPH increased blood pressure and heart rate to a statistically, but not clinically, significant degree (P < .05); medication discontinuation did not differ significantly between treatments. Treatment for ADHD did not improve smoking cessation success; OROS-MPH, relative to placebo, effectively treated ADHD and was safe and generally well tolerated in this healthy sample of adult ADHD smokers. clinical trials.gov Identifier: NCT00253747. © Copyright 2010 Physicians Postgraduate Press, Inc.
Le Grange, Daniel; Lock, James; Agras, W Stewart; Bryson, Susan W; Jo, Booil
2015-11-01
There is a paucity of randomized clinical trials (RCTs) for adolescents with bulimia nervosa (BN). Prior studies suggest cognitive-behavioral therapy adapted for adolescents (CBT-A) and family-based treatment for adolescent bulimia nervosa (FBT-BN) could be effective for this patient population. The objective of this study was to compare the relative efficacy of these 2 specific therapies, FBT-BN and CBT-A. In addition, a smaller participant group was randomized to a nonspecific treatment (supportive psychotherapy [SPT]), whose data were to be used if there were no differences between FBT-BN and CBT-A at end of treatment. This 2-site (Chicago and Stanford) randomized controlled trial included 130 participants (aged 12-18 years) meeting DSM-IV criteria for BN or partial BN (binge eating and purging once or more per week for 6 months). Outcomes were assessed at baseline, end of treatment, and 6 and 12 months posttreatment. Treatments involved 18 outpatient sessions over 6 months. The primary outcome was defined as abstinence from binge eating and purging for 4 weeks before assessment, using the Eating Disorder Examination. Participants in FBT-BN achieved higher abstinence rates than in CBT-A at end of treatment (39% versus 20%; p = .040, number needed to treat [NNT] = 5) and at 6-month follow-up (44% versus 25%; p = .030, NNT = 5). Abstinence rates between these 2 groups did not differ statistically at 12-month follow-up (49% versus 32%; p = .130, NNT = 6). In this study, FBT-BN was more effective in promoting abstinence from binge eating and purging than CBT-A in adolescent BN at end of treatment and 6-month follow-up. By 12-month follow-up, there were no statistically significant differences between the 2 treatments. Study of Treatment for Adolescents With Bulimia Nervosa; http://clinicaltrials.gov/; NCT00879151. Copyright © 2015 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.
Impact of Varying Levels of Disease Management on Smoking Cessation: A Randomized Trial
Ellerbeck, Edward F.; Mahnken, Jonathan D.; Cupertino, A. Paula; Cox, Lisa Sanderson; Greiner, K. Allen; Mussulman, Laura M.; Nazir, Niaman; Shireman, Theresa I.; Resnicow, Kenneth; Ahluwalia, Jasjit S.
2010-01-01
Background Cigarette smoking is a chronic, relapsing illness that is inadequately addressed in primary care practice. Objective To compare cessation rates among smokers receiving pharmacotherapy management alone or combined with either moderate- or high-intensity disease management that includes counseling and provider feedback. Design Randomized clinical trial from June 2004 to December 2007. Setting 50 rural primary care practices. Patients 750 patients smoking ≥ 10 cigarettes/day. Intervention Participants were randomized to one of three groups: pharmacotherapy management (n = 250); pharmacotherapy management supplemented with up to 2 counseling calls (moderate-intensity disease management (n = 249)); or pharmacotherapy management supplemented with up to 6 counseling calls (high-intensity disease management (n = 251)). Interventions were offered every six months for two years. All participants received offers of free pharmacotherapy; moderate-intensity and high-intensity disease management recipients had post-counseling progress reports faxed to their physicians. Participants and counselors were not blinded to treatment assignment. Measurements Self-reported point-prevalence smoking abstinence at 24 months (primary outcome) and overall (0 to 24 months) analyses of smoking abstinence, utilization of pharmacotherapy, and discussions about smoking with physicians (secondary outcomes). Research assistants, blinded to treatment assignment, conducted outcome assessments. Results Pharmacotherapy utilization was comparable across treatment groups, with 473 of 741 (63.8%), 302 of 739 (40.9%), 175 of 732 (23.9%), and 179 of 726 (24.7%) requesting pharmacotherapy during the 1st, 2nd, 3rd, and 4th 6-month cycles of treatment. Of participants that saw a physician during any given treatment cycle, 37.5 – 59.5% reported that they discussed smoking cessation with their physician, but this did not differ across the treatment groups. Abstinence rates increased throughout the
Levin, Frances R; Mariani, John J; Pavlicova, Martina; Brooks, Daniel; Glass, Andrew; Mahony, Amy; Nunes, Edward V; Bisaga, Adam; Dakwar, Elias; Carpenter, Kenneth M; Sullivan, Maria A; Choi, Jean C
2016-02-01
Cannabis use disorder is associated with substantial morbidity and, after alcohol, is the most common drug bringing adolescents and adults into treatment. At present, there are no FDA-approved medications for cannabis use disorder. Combined pharmacologic interventions might be particularly useful in mitigating withdrawal symptoms and promoting abstinence. The purpose of this study was to evaluate the safety and efficacy of dronabinol, a synthetic form of delta-9-tetrahydrocannabinol, a naturally occurring pharmacologically active component of marijuana, and lofexidine, an alpha-2 agonist, in treating cannabis dependence. One hundred fifty six cannabis-dependent adults were enrolled and following a 1-week placebo lead-in phase 122 were randomized in a double-blind, placebo-controlled, 11-week trial. Participants were randomized to receive dronabinol 20mg three times a day and lofexidine 0.6 mg three times a day or placebo. Medications were maintained until the end of week eight, were then tapered over two weeks and patients were monitored off medications during the last study week. All participants received weekly motivational enhancement and relapse prevention therapy. Marijuana use was assessed using the timeline follow-back method. There was no significant difference between treatment groups in the proportion of participants who achieved 3 weeks of abstinence during the maintenance phase of the trial (27.9% for the medication group and 29.5% for the placebo group), although both groups showed a reduction over time. Based on this treatment study, the combined intervention did not show promise as a treatment for cannabis use disorder. Published by Elsevier Ireland Ltd.
Levin, Frances R.; Mariani, John J.; Pavlicova, Martina; Brooks, Daniel; Glass, Andrew; Mahony, Amy; Nunes, Edward V.; Bisaga, Adam; Dakwar, Elias; Carpenter, Kenneth M.; Sullivan, Maria A.; Choi, Jean C.
2016-01-01
Background Cannabis use disorder is associated with substantial morbidity and, after alcohol, is the most common drug bringing adolescents and adults into treatment. At present, there are no FDA-approved medications for cannabis use disorder. Combined pharmacologic interventions might be particularly useful in mitigating withdrawal symptoms and promoting abstinence. Objective The purpose of this study was to evaluate the safety and efficacy of dronabinol, a synthetic form of delta-9-tetrahydrocannabinol, a naturally occurring pharmacologically active component of marijuana, and lofexidine, an alpha-2 agonist, in treating cannabis dependence. Methods One hundred fifty six cannabis-dependent adults were enrolled and following a 1-week placebo lead-in phase 122 were randomized in a double-blind, placebo-controlled, 11-week trial. Participants were randomized to receive dronabinol 20 mg three times a day and lofexidine 0.6 mg three times a day or placebo. Medications were maintained until the end of week eight, were then tapered over two weeks and patients were monitored off medications during the last study week. All participants received weekly motivational enhancement and relapse prevention therapy. Marijuana use was assessed using the timeline follow-back method. Results There was no significant difference between treatment groups in the proportion of participants who achieved 3 weeks of abstinence during the maintenance phase of the trial (27.9 % for the medication group and 29.5% for the placebo group), although both groups showed a reduction over time. Conclusions Based on this treatment study, the combined intervention did not show promise as a treatment for cannabis use disorder. PMID:26711160
A randomized trial of nicotine-replacement therapy patches in pregnancy.
Coleman, Tim; Cooper, Sue; Thornton, James G; Grainge, Matthew J; Watts, Kim; Britton, John; Lewis, Sarah
2012-03-01
Nicotine-replacement therapy is effective for smoking cessation outside pregnancy and its use is widely recommended during pregnancy. We investigated the efficacy and safety of nicotine patches during pregnancy. We recruited participants from seven hospitals in England who were 16 to 50 years of age with pregnancies of 12 to 24 weeks' gestation and who smoked five or more cigarettes per day. Participants received behavioral cessation support and were randomly assigned to 8 weeks of treatment with active nicotine patches (15 mg per 16 hours) or matched placebo patches. The primary outcome was abstinence from the date of smoking cessation until delivery, as validated by measurement of exhaled carbon monoxide or salivary cotinine. Safety was assessed by monitoring for adverse pregnancy and birth outcomes. Of 1050 participants, 521 were randomly assigned to nicotine-replacement therapy and 529 to placebo. There was no significant difference in the rate of abstinence from the quit date until delivery between the nicotine-replacement and placebo groups (9.4% and 7.6%, respectively; unadjusted odds ratio with nicotine-replacement therapy, 1.26; 95% confidence interval, 0.82 to 1.96), although the rate was higher at 1 month in the nicotine-replacement group than in the placebo group (21.3% vs. 11.7%). Compliance was low; only 7.2% of women assigned to nicotine-replacement therapy and 2.8% assigned to placebo used patches for more than 1 month. Rates of adverse pregnancy and birth outcomes were similar in the two groups. Adding a nicotine patch (15 mg per 16 hours) to behavioral cessation support for women who smoked during pregnancy did not significantly increase the rate of abstinence from smoking until delivery or the risk of adverse pregnancy or birth outcomes. However, low compliance rates substantially limited the assessment of safety. (Funded by the National Institute for Health Research Health Technology Assessment Programme; Current Controlled Trials number, ISRCTN
ERIC Educational Resources Information Center
Petry, Nancy M.; Barry, Danielle; Alessi, Sheila M.; Rounsaville, Bruce J.; Carroll, Kathleen M.
2012-01-01
Objective: Contingency management (CM) reduces drug use, but questions remain regarding optimal targets and magnitudes of reinforcement. We evaluated the efficacy of CM reinforcing attendance in patients who initiated treatment with cocaine-negative samples, and of higher magnitude abstinence-based CM in patients who began treatment positive.…
Chan, Sophia Siu Chee; Cheung, Yee Tak Derek; Fong, Daniel Yee Tak; Emmons, Karen; Leung, Angela Yee Man; Leung, Doris Yin Ping; Lam, Tai Hing
2017-03-01
To examine whether a family-based intervention targeting both smoking fathers and nonsmoking mothers in well-child health clinics is effective in increasing fathers' abstinence from cigarette smoking. This parallel 2-arm randomized controlled trial recruited a total of 1158 families with a daily-smoking father, a nonsmoking mother, and a child aged 0-18 months from the 22 maternal and child health centers in Hong Kong. The intervention group received the family-based intervention, including 6 nurse-led individual face-to-face and telephone counseling sessions within 1 month after recruitment and a voluntary face-to-face family counseling session (FCS). The control group received a leaflet, a self-help booklet, and brief quitting advice only. Father-reported 7-day and 6-month abstinence, smoking reduction, quit attempts, mother-reported help and support, and child salivary cotinine level were assessed at 12 months. Generalized estimating equation models were used to compare these outcomes between the 2 study groups. Compared with the control group, the intervention group reported a greater prevalence of 7-day (13.7% vs 8.0%; OR, 1.92; 95% CI, 1.16-3.17; P < .01) and 6-month self-reported abstinence (13.4% vs. 7.5%; OR, 2.10; 95% CI, 1.30-3.40; P < .01). Within the intervention group, compared with receipt of individual counseling only, participation in the FCS was associated with increases in fathers' self-reported abstinence (20.2% vs 12.3%; P = .02), mothers' help (66.1% vs 43.8%; P < .01), and support to the fathers (55.0% vs 45.4%; P < .01). The family-based smoking cessation intervention for the families in the well-child healthcare setting was effective in increasing the fathers' self-reported abstinence. Additional participation in the FCS increased mothers' help and support to the fathers. Controlled-trials.com: ISRCTN99111655; Hkuctr.com: HKUCTR-465. Copyright © 2016 Elsevier Inc. All rights reserved.
2018-06-13
To examine the effectiveness of a nicotine patch worn for four weeks before a quit attempt. Randomised controlled open label trial. Primary care and smoking cessation clinics in England, 2012-15. 1792 adults who were daily smokers with tobacco dependence. 899 were allocated to the preloading arm and 893 to the control arm. Participants were randomised 1:1, using concealed randomly permuted blocks stratified by centre, to either standard smoking cessation pharmacotherapy and behavioural support or the same treatment supplemented by four weeks of 21 mg nicotine patch use before quitting: "preloading." The primary outcome was biochemically confirmed prolonged abstinence at six months. Secondary outcomes were prolonged abstinence at four weeks and 12 months. Biochemically validated abstinence at six months was achieved by 157/899 (17.5%) participants in the preloading arm and 129/893 (14.4%) in the control arm: difference 3.0% (95% confidence interval -0.4% to 6.4%), odds ratio 1.25 (95% confidence interval 0.97 to 1.62), P=0.08 in the primary analysis. There was an imbalance between arms in the frequency of varenicline use as post-cessation treatment, and planned adjustment for this gave an odds ratio for the effect of preloading of 1.34 (95% confidence interval 1.03 to 1.73), P=0.03: difference 3.8% (0.4% to 7.2%). At four weeks, the difference in prolonged abstinence unadjusted for varenicline use was odds ratio 1.21 (1.00 to 1.48), difference 4.3% (0.0% to 8.7%), P=0.05, and adjusted for varenicline use was 1.32 (1.08 to 1.62) P=0.007. At 12 months the odds ratio was 1.28 (0.97 to 1.69), difference 2.7% (-0.4% to 5.8%), P=0.09 unadjusted for varenicline use and after adjustment was 1.36 (1.02 to 1.80) P=0.04. 5.9% of participants discontinued preloading owing to intolerance. Gastrointestinal symptoms-chiefly nausea-occurred in 4.0% (2.2% to 5.9%) more people in the preloading arm than control arm. Eight serious adverse events occurred in the preloading arm and
McClure, Erin A; Sonne, Susan C; Winhusen, Theresa; Carroll, Kathleen M; Ghitza, Udi E; McRae-Clark, Aimee L; Matthews, Abigail G; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G; Levin, Frances R; Weiss, Roger D; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J; Haynes, Louise; Brigham, Gregory S; Sparenborg, Steve; Hasson, Albert L; Gray, Kevin M
2014-11-01
Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18-50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders. Copyright © 2014 Elsevier Inc. All rights reserved.
McClure, Erin A.; Sonne, Susan C.; Winhusen, Theresa; Carroll, Kathleen M.; Ghitza, Udi E.; McRae-Clark, Aimee L.; Matthews, Abigail G.; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G.; Levin, Frances R.; Weiss, Roger D.; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J.; Haynes, Louise; Brigham, Gregory S.; Sparenborg, Steve; Hasson, Albert L.; Gray, Kevin M.
2014-01-01
Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18–50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders. PMID:25179587
Quitline cessation counseling for young adult smokers: a randomized clinical trial.
Sims, Tammy H; McAfee, Timothy; Fraser, David L; Baker, Timothy B; Fiore, Michael C; Smith, Stevens S
2013-05-01
One in 5 young adults in the United States currently smoke, and young adults are less likely than other smokers to make aided quit attempts. Telephone quitlines may be a useful tool for treating this population. This study tested a quitline-based smoking cessation intervention versus mailed self-help materials in smokers 18-24 years old. This was a 2-group randomized clinical trial. The quitline-based counseling intervention (CI) included up to 4 proactive telephone counseling sessions; participants in the self-help (SH) group received only mailed cessation materials. Participants included 410 young adults who had smoked at least 1 cigarette in the past 30 days and who called the Wisconsin Tobacco Quit Line (WTQL) for help with quitting. Primary study outcomes included whether or not a quit date was set, whether or not a serious quit attempt was undertaken, and self-reported 7-day point-prevalence abstinence at 1-, 3-, and 6-month postenrollment. The CI and SH groups did not differ in the intent-to-treat abstinence analyses at any of the follow-ups. However, the CI group was significantly more likely to set a quit date at 1-month postenrollment. Follow-up response rates were low (67.8% at 1 month; 53.4% at 3 months; and 48.3% at 6 months) reflecting lower motivation to participate in this kind of research. Relative to self-help, quitline counseling motivated young adults to set a quit date but abstinence rates were not improved. Research is needed on how to motivate young adult smokers to seek cessation treatment including quitline services.
Promoting Abstinence from Cocaine and Heroin with a Methadone Dose Increase and a Novel Contingency
Schmittner, John; Umbricht, Annie; Schroeder, Jennifer R.; Moolchan, Eric T.; Preston, Kenzie L.
2010-01-01
To test whether a combination of contingency management and methadone dose increase would promote abstinence from heroin and cocaine, we conducted a randomized controlled trial using a 2 X 3 (Dose X Contingency) factorial design in which dose assignment was double-blind. Participants were 252 heroin- and cocaine-abusing outpatients on methadone maintenance. They were randomly assigned to methadone dose (70 or 100 mg/day, double blind) and voucher condition (noncontingent, contingent on cocaine-negative urines, or “split”). The “split” contingency was a novel contingency that reinforced abstinence from either drug while doubly reinforcing simultaneous abstinence from both: the total value of incentives was “split” between drugs to contain costs. The main outcome measures were percentages of urine specimens negative for heroin, cocaine, and both simultaneously; these were monitored during a 5-week baseline of standard treatment (to determine study eligibility), a 12-week intervention, and a 10-week maintenance phase (to examine intervention effects in return-to-baseline conditions). DSM-IV criteria for ongoing drug dependence were assessed at study exit. Urine-screen results showed that the methadone dose increase reduced heroin use but not cocaine use. The Split 100mg group was the only group to achieve a longer duration of simultaneous negatives than its same-dose Noncontingent control group. The frequency of DSM-IV opiate and cocaine dependence diagnoses decreased in the active intervention groups. For a split contingency to promote simultaneous abstinence from cocaine and heroin, a relatively high dose of methadone appears necessary but not sufficient; an increase in overall incentive amount may also be required. PMID:19101098
The role of gender in a smoking cessation intervention: a cluster randomized clinical trial.
Puente, Diana; Cabezas, Carmen; Rodriguez-Blanco, Teresa; Fernández-Alonso, Carmen; Cebrian, Tránsito; Torrecilla, Miguel; Clemente, Lourdes; Martín, Carlos
2011-05-23
The prevalence of smoking in Spain is high in both men and women. The aim of our study was to evaluate the role of gender in the effectiveness of a specific smoking cessation intervention conducted in Spain. This study was a secondary analysis of a cluster randomized clinical trial in which the randomization unit was the Basic Care Unit (family physician and nurse who care for the same group of patients). The intervention consisted of a six-month period of implementing the recommendations of a Clinical Practice Guideline. A total of 2,937 current smokers at 82 Primary Care Centers in 13 different regions of Spain were included (2003-2005). The success rate was measured by a six-month continued abstinence rate at the one-year follow-up. A logistic mixed-effects regression model, taking Basic Care Units as random-effect parameter, was performed in order to analyze gender as a predictor of smoking cessation. At the one-year follow-up, the six-month continuous abstinence quit rate was 9.4% in men and 8.5% in women (p = 0.400). The logistic mixed-effects regression model showed that women did not have a higher odds of being an ex-smoker than men after the analysis was adjusted for confounders (OR adjusted = 0.9, 95% CI = 0.7-1.2). Gender does not appear to be a predictor of smoking cessation at the one-year follow-up in individuals presenting at Primary Care Centers. CLINICALTRIALS.GOV IDENTIFIER: NCT00125905.
Nayeri, Fatemeh; Sheikh, Mahdi; Kalani, Majid; Niknafs, Pedram; Shariat, Mamak; Dalili, Hosein; Dehpour, Ahmad-Reza
2015-05-15
Evaluating the efficacy of the loading and tapering dose of Phenobarbital versus oral Morphine in the management of NAS. This randomized, open-label, controlled trial was conducted on 60 neonates born to illicit drugs dependent mothers at Vali-Asr and Akbar-Abadi hospitals, Tehran, Iran, who exhibited NAS requiring medical therapy. The neonates were randomized to receive either: Oral Morphine Sulfate or a loading dose of Phenobarbital followed by a tapering dose. The duration of treatment required for NAS resolution, the total hospital stay and the requirement for additional second line treatment were compared between the treatment groups. The Mean ± Standard Deviation for the duration of treatment required for the resolution of NAS was 8.5 ± 5 days in the Morphine group and 8.5 ± 4 days in the Phenobarbital group (P = 0.9). The duration of total hospital stay was 12.6 ± 5.6 days in the Morphine group and 12.5 ± 5.3 days in the Phenobarbital group (P = 0.7). 3.3 % in the Morphine group versus 6.6 % in the Phenobarbital group required adjunctive treatment (P = 0.5). There were no significant differences in the duration of treatment, duration of hospital stay, and the requirement for adjunctive treatment, between the neonates with NAS who received Morphine Sulfate and neonates who received a loading and tapering dose of Phenobarbital. This study is registered at the Iranian Registry of Clinical Trials ( www.irct.ir ) which is a Primary Registry in the WHO Registry Network. (Registration Number = IRCT201406239568N8 ).
Limsanon, Thatsanee; Kalayasiri, Rasmon
2015-03-01
Cigarette craving usually occurs in conjunction with unpleasant feelings, including stress, as part of a withdrawal syndrome. Progressive muscle relaxation (PMR), a behavioral technique used to reduce stress by concentrating on achieving muscle relaxation, may reduce levels of cigarette craving and other substance-related negative feelings and withdrawal symptoms. Demographic and cigarette use data were collected from 32 experienced smokers at the King Chulalongkorn Memorial Hospital, Bangkok, Thailand using the Semi-Structured Assessment for Drug Dependence and Alcoholism. Participants were asked to refrain from smoking for at least 3 hours before the visit (acute abstinence) and were randomly allocated to a 1-session PMR group (n =16) or a control activity group (e.g., reading newspaper, n =16). The intervention group was instructed to practice PMR individually in a quiet, private, air-conditioned room for about 20minutes. Craving, other substance-related feelings, and autonomic nervous responses (e.g., blood pressure and pulse rate) were assessed immediately before and after the 1-session intervention. There were no differences in demographics, cigarette use/dependence, and baseline craving characteristics between the PMR and control groups. However, the control group had higher levels of high and paranoia feeling, and pulse rate than the PMR group at baseline. After practicing PMR, but not after a control activity, smokers undergoing acute abstinence had significantly lower levels of cigarette craving, withdrawal symptoms, and systolic blood pressure than at baseline. After controlling for baseline differences, abstaining smokers using PMR had lower levels of cigarette craving, withdrawal symptoms, and systolic blood pressure than smokers who undertook a control activity. PMR significantly reduces cigarette craving, withdrawal symptoms, and blood pressure in smokers undergoing acute abstinence. PMR may be used as an adjunct to cigarette dependency treatments
Daley, Marilyn C.; Neuman, Matthew J.; Blaakman, Aaron P.; McKay, James R.
2016-01-01
Purpose To investigate whether telephone-based continuing care (TEL) is a promising alternative to traditional face-to-face counseling for clients in treatment for substance abuse. Methods Patients with alcohol and/or cocaine dependence who had completed a 4-week intensive outpatient program were randomly assigned through urn randomization into one of three 12-week interventions: standard continuing care (STD), in-person relapse prevention (RP), or telephone-based continuing care (TEL). This study performed cost, cost-effectiveness, and cost-benefit analyses of TEL and RP compared to STD, using results from the randomized clinical trial with two years of follow up (359 participants). In addition, the study examined the potential moderating effect of baseline patient costs on economic outcomes. Results The study found that TEL was less expensive per client from the societal perspective ($569) than STD ($870) or RP ($1,684). TEL also was also significantly more effective, with an abstinence rate of 57.1% compared to 46.7% for STD (p<0.05). Thus TEL dominated STD, with a highly favorable negative incremental cost-effectiveness ratio (−$1,400 per abstinent year). TEL also proved favorable under a benefit-cost perspective. Conclusions TEL proved to be a cost-effective and cost-beneficial contributor to long-term recovery over two years. Because TEL dominated STD care interventions, wider adoption should be considered. PMID:26718395
Shepard, Donald S; Daley, Marilyn C; Neuman, Matthew J; Blaakman, Aaron P; McKay, James R
2016-02-01
To investigate whether telephone-based continuing care (TEL) is a promising alternative to traditional face-to-face counseling for clients in treatment for substance abuse. Patients with alcohol and/or cocaine dependence who had completed a 4-week intensive outpatient program were randomly assigned through urn randomization into one of three 12-week interventions: standard continuing care (STD), in-person relapse prevention (RP), or telephone-based continuing care (TEL). This study performed cost, cost-effectiveness, and cost-benefit analyses of TEL and RP compared to STD, using results from the randomized clinical trial with two years of follow up (359 participants). In addition, the study examined the potential moderating effect of baseline patient costs on economic outcomes. The study found that TEL was less expensive per client from the societal perspective ($569) than STD ($870) or RP ($1684). TEL also was also significantly more effective, with an abstinence rate of 57.1% compared to 46.7% for STD (p<0.05). Thus TEL dominated STD, with a highly favorable negative incremental cost-effectiveness ratio (-$1400 per abstinent year). TEL also proved favorable under a benefit-cost perspective. TEL proved to be a cost-effective and cost-beneficial contributor to long-term recovery over two years. Because TEL dominated STD care interventions, wider adoption should be considered. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Thylstrup, Birgitte; Schrøder, Sidsel; Fridell, Mats; Hesse, Morten
2017-01-09
People in treatment for substance use disorder commonly have comorbid personality disorders, including antisocial personality disorder. Little is known about treatments that specifically address comorbid antisocial personality disorder. Self-rated help received for antisocial personality disorder was assessed during follow-ups at 3, 9 and 15 months post-randomization of a randomized trial of psychoeducation for people with comorbid substance use and antisocial personality disorder (n = 175). Randomization to psychoeducation was associated with increased perceived help for antisocial personality disorder. Perceived help for antisocial personality disorder was in turn associated with more days abstinent and higher treatment satisfaction at the 3-month follow-up, and reduced risk of dropping out of treatment after the 3-month follow-up, and perceived help mediated the effects of random assignment on days abstinent at 3-month. Brief psychoeducation for antisocial personality disorder increased patients' self-rated help for antisocial personality disorder in substance abuse treatment, and reporting having received help for antisocial personality disorder was in turn associated with better short-term outcomes, e.g., days abstinent, dropout from treatment and treatment satisfaction. ISRCTN registry, ISRCTN67266318 , retrospectively registered 17/7/2012.
2014-01-01
Background It is well established in studies across several countries that tobacco smoking is more prevalent among schizophrenic patients than the general population. Electronic cigarettes are becoming increasingly popular with smokers worldwide. To date there are no large randomized trials of electronic cigarettes in schizophrenic smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population. Methods/Design Intervention: We have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. The trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in schizophrenic smokers not intending to quit. We will also monitor quality of life, neurocognitive functioning and measure participants’ perception and satisfaction of the product. Outcome measures: A ≥50% reduction in the number of cigarettes/day from baseline, will be calculated at each study visit (“reducers”). Abstinence from smoking will be calculated at each study visit (“quitters”). Smokers who leave the study protocol before its completion and will carry out the Early Termination Visit or who will not satisfy the criteria of “reducers” and “quitters” will be defined “non responders”. Statistical analysis: The differences of continuous variables between the three groups will be evaluated with the Kruskal-Wallis Test, followed by the Dunn multiple comparison test. The differences between the three groups for normally distributed data will be evaluated with ANOVA test one way, followed by the Newman-Keuls multiple comparison test. The normality of the distribution will be evaluated with the Kolmogorov-Smirnov test. Any correlations between the variables under evaluation will be assessed by Spearman r correlation. To compare qualitative data will be used the Chi-square test. Discussion The main strengths of
Kushnir, Vladyslav; Selby, Peter; Zawertailo, Laurie; Tyndale, Rachel F; Leatherdale, Scott T; Cunningham, John A
2017-07-18
Our group recently completed a randomized controlled trial, evaluating the efficacy of providing 5 weeks of free nicotine replacement therapy (NRT; in the form of the nicotine patch) by expedited postal mail without behavioral assistance to regular adult smokers interested in receiving it. The findings revealed that mailed provision of nicotine patches resulted in more than a doubling of quit rates at a six-month follow-up compared to a no intervention control group. While this trial provided evidence for the effectiveness of mailed nicotine patches in promoting cessation, the findings speak only to the short term effectiveness of this approach. As relapse to smoking is known to occur beyond the 6 month period, it is important to evaluate whether the net benefit of NRT in naturalistic settings can be maintained long-term. The present study aims to perform a 5-year follow-up survey of participants in the original trial to evaluate the long-term effectiveness of mailed NRT. Trained interviewers will contact participants in the randomized controlled trial 5 years post-enrollment. A total of 924 participants will be eligible to be contacted. Interviewers will first assess participants' smoking status and their level of nicotine dependence. Participants reporting not currently smoking will be asked whether they have smoked tobacco, even a puff, in the last 30 days (primary outcome measure: 30-day point prevalence abstinence), past 6 months (secondary outcome measure: prolonged 6-month abstinence), and since the 8-week follow-up survey (secondary outcome measure: > 4 year continuous abstinence). Interviewers will be blind to experimental condition at the time the primary outcome measure will be assessed. It is hypothesized that participants who received nicotine patches at baseline will display significantly higher quit rates at the 5-year follow-up as compared to participants who did not receive nicotine patches at baseline. If the study finds that the mailed
Heinzerling, Keith G.; Swanson, Aimee-Noelle; Hall, Timothy M.; Yi, Yi; Wu, Yingnian; Shoptaw, Steven J.
2014-01-01
Aims Two previous randomized trials found an effect for bupropion in reducing methamphetamine use in the subgroup with lower frequency of methamphetamine use at baseline. This study aimed to replicate these results by comparing bupropion versus placebo in methamphetamine dependent participants with less than daily methamphetamine use at baseline. Methods Methamphetamine dependent volunteers reporting methamphetamine use on ≤ 29 of past 30 days were randomized to bupropion 150mg twice daily (N=41) or placebo (N=43) and outpatient counseling for 12 weeks. The primary outcome was the proportion achieving end of treatment (EOT) methamphetamine abstinence (weeks 11 and 12) for bupropion versus placebo. A post hoc analysis compared EOT abstinence by medication adherence assessed via plasma bupropion/hydroxybupropion level. Results There was no significant difference in EOT abstinence between bupropion (29%, 12/41) and placebo (14%, 6/43; p = 0.087). Among participants receiving bupropion, EOT abstinence was significantly higher in participants assessed as medication adherent by plasma bupropion/hydroxybupropion levels (54%, 7/13) compared to non-adherent participants (18%, 5/28; p = 0.018). Medication adherence by plasma levels was low (32%). Conclusions Bupropion may be efficacious for methamphetamine dependence but only in a highly selected subgroup of medication adherent participants with less than daily baseline methamphetamine use. Even a single objective “snapshot” measure of medication adherence is highly associated with treatment outcomes. PMID:24894963
Chan, Sophia S C; Wong, David C N; Cheung, Yee Tak Derek; Leung, Doris Y P; Lau, Lisa; Lai, Vienna; Lam, Tai-Hing
2015-08-01
The present trial examined the effectiveness of brief interventions for smokers who joined the Hong Kong Quit to Win Contest to quit smoking. A block randomized controlled trial allocated 1003 adult daily smokers to three groups: (i) The TEL group (n = 338) received a 5-min nurse-led telephone counselling; (ii) The SMS group (n = 335) received eight text messages through mobile phone and (iii) The CONTROL group (n = 330) did not receive the above interventions. Participants with biochemically verified abstinence at 6-month follow-up could receive cash incentive. The primary outcome was the self-reported 7-day point prevalence (PP) of tobacco abstinence at 6-month follow-up. The abstinence rate in the TEL, SMS and CONTROL group was 22.2, 20.6 and 20.3%, respectively (P for TEL versus CONTROL = 0.32; P for SMS versus CONTROL = 0.40). When abstinence at 2-, 6- and 12-month follow-up was modelled simultaneously, the TEL group had a higher abstinence than the CONTROL group (Adjusted OR = 1.38, 95% CI = 1.01-1.88, P = 0 .04). In the Quit to Win Contest, the brief telephone counselling might have increased abstinence, but the text messages had no significant effect. Further studies on intensive intervention and interactive messaging services are warranted. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.
Schumacher, Joseph E.; Wallace, Dennis; Vuchinich, Rudy; Mennemeyer, Stephen T.; Kertesz, Stefan G.
2010-01-01
Objectives. We examined whether cocaine-dependent homeless persons had stable housing and were employed 6, 12, and 18 months after they entered a randomized controlled trial comparing 2 treatments. Methods. One group (n = 103) received abstinence-contingent housing, vocational training, and work; another group (n = 103) received the same intervention plus cognitive behavioral day treatment. We examined baseline and early treatment variables for association with long-term housing and employment. Results. Although the enhanced-treatment group achieved better abstinence rates, the groups did not differ in long-term housing and employment stability. However, consecutive weeks of abstinence during treatment (and to a lesser extent, older age and male gender) predicted long-term housing and employment stability after adjustment for baseline differences in employment, housing, and treatment. Conclusions. Our data showed a relationship of abstinence with housing stability. Contrasting these results with the increasingly popular Housing First interventions reveals important gaps in our knowledge to be addressed in future research. PMID:19833998
Ponizovsky, Alexander M; Rosca, Paola; Aronovich, Edward; Weizman, Abraham; Grinshpoon, Alexander
2015-05-01
Limited clinical trials and case-reports yielded conflicting results regarding the efficacy of baclofen (a GABAB agonist) in the treatment of alcohol dependence. The aim of this study was to test the efficacy and tolerability of baclofen in alcohol dependent patients in Israel. The study was a double-blind, placebo-controlled, randomized trial comparing 50mg/day of baclofen to placebo over 12 weeks, in addition to a standard psychosocial intervention program, with 26-week and 52-week follow-up observations. The percentages of heavy drinking days and abstinent days were the primary outcome measures, and craving, distress and depression levels; self-efficacy; social support from different sources; and health-related quality of life (HRQL) were secondary outcomes. Tolerability was also examined. Sixty-four patients were randomized; 62% completed the 12-week trial and 37% completed the 52-week follow-up. No between group differences were found in the percentages of heavy drinking and abstinent days. A significant reduction in levels of distress, depression and craving and improved HRQL occurred for both arms, whereas self-efficacy and social support remained unchanged in both groups. No adverse events were observed. Unlike previous positive trials in Italy, and similarly to a negative trial in the USA, we found no evidence of superiority of baclofen over placebo in the treatment of alcohol dependence. However, the high placebo response undermines the validity of this conclusion. Therefore, more placebo-controlled trials are needed to either verify or discard a possible clinical efficacy of baclofen for alcohol dependence. Copyright © 2015 Elsevier Inc. All rights reserved.
Bernstein, Steven L; D'Onofrio, Gail; Rosner, June; O'Malley, Stephanie; Makuch, Robert; Busch, Susan; Pantalon, Michael V; Toll, Benjamin
2015-08-01
Tobacco use is common among emergency department (ED) patients, many of whom have low income. Our objective is to study the efficacy of an intervention incorporating motivational interviewing, nicotine replacement, and quitline referral for adult smokers in an ED. This was a 2-arm randomized clinical trial conducted from October 2010 to December 2012 in a northeastern urban US ED with 90,000 visits per year. Eligible subjects were aged 18 years or older, smoked, and were self-pay or had Medicaid insurance. Intervention subjects received a motivational interview by a trained research assistant, 6 weeks' worth of nicotine patches and gum initiated in the ED, a faxed referral to the state smokers' quitline, a booster call, and a brochure. Control subjects received the brochure, which provided quitline information. The primary outcome was biochemically confirmed tobacco abstinence at 3 months. Secondary endpoints included quitline use. Of 778 enrolled subjects, 774 (99.5%) were alive at 3 months. The prevalence of biochemically confirmed abstinence was 12.2% (47/386) in the intervention arm versus 4.9% (19/388) in the control arm, for a difference in quit rates of 7.3% (95% confidence interval 3.2% to 11.5%). In multivariable logistic modeling controlling for age, sex, and race or ethnicity, study subjects remained more likely to be abstinent than controls (odds ratio 2.72; 95% confidence interval 1.55 to 4.75). An intensive intervention improved tobacco abstinence rates in low-income ED smokers. Because approximately 20 million smokers, many of whom have low income, visit US EDs annually, these results suggest that ED-initiated treatment may be an effective technique to treat this group of smokers. Copyright © 2015 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.
Freeman, WM; Patel, KM; Brucklacher, RM; Lull, ME; Erwin, M; Morgan, D; Roberts, DCS; Vrana, KE
2010-01-01
Cocaine-responsive gene expression changes have been described after either no drug abstinence or short periods of abstinence. Little data exist on the persistence of these changes after long-term abstinence. Previously, we reported that after discrete-trial, cocaine self-administration and 10 days of forced abstinence, incubation of cocaine reinforcement was observable by a progressive ratio schedule. The present study used rat discrete-trial cocaine self-administration and long-term forced abstinence to examine: extinction responding, mRNA abundance of known cocaine-responsive genes, and chromatin remodeling. At 30 and 100 days of abstinence, extinction responding increased compared to 3-day abstinent rats. Decreases in both medial prefrontal cortex (mPFC) and nucleus accumbens (NAc) c-fos, Nr4a1, Arc, and EGR1 mRNA were observed, and in most cases persisted, for 100 days of abstinence. The signaling peptides CART and NPY transiently increased in the mPFC, but returned to baseline levels following 10 days of abstinence. To investigate a potential regulatory mechanism for these persistent mRNA changes, levels of histone H3 acetylation at promoters for genes with altered mRNA expression were examined. In the mPFC, histone H3 acetylation decreased after 1 and 10 days of abstinence at the promoter for EGR1. H3 acetylation increased for NPY after 1 day of abstinence and returned to control levels by 10 days of abstinence. Behaviorally, these results demonstrate incubation after discrete-trial cocaine self-administration and prolonged forced abstinence. This incubation is accompanied by changes in gene expression that persist long after cessation of drug administration and may be regulated by chromatin remodeling. PMID:17851536
Koegelenberg, Coenraad F N; Noor, Firdows; Bateman, Eric D; van Zyl-Smit, Richard N; Bruning, Axel; O'Brien, John A; Smith, Clifford; Abdool-Gaffar, Mohamed S; Emanuel, Shaunagh; Esterhuizen, Tonya M; Irusen, Elvis M
2014-07-01
Behavioral approaches and pharmacotherapy are of proven benefit in assisting smokers to quit, but it is unclear whether combining nicotine replacement therapy (NRT) with varenicline to improve abstinence is effective and safe. To evaluate the efficacy and safety of combining varenicline and a nicotine patch vs varenicline alone in smoking cessation. Randomized, blinded, placebo-controlled clinical trial with a 12-week treatment period and a further 12-week follow-up conducted in 7 centers in South Africa from April 2011 to October 2012. Four hundred forty-six generally healthy smokers were randomized (1:1); 435 were included in the efficacy and safety analyses. Nicotine or placebo patch treatment began 2 weeks before a target quit date (TQD) and continued for a further 12 weeks. Varenicline was begun 1 week prior to TQD, continued for a further 12 weeks, and tapered off during week 13. Tobacco abstinence was established and confirmed by exhaled carbon monoxide measurements at TQD and at intervals thereafter up to 24 weeks. The primary end point was the 4-week exhaled carbon monoxide-confirmed continuous abstinence rate for weeks 9 through 12 of treatment, ie, the proportion of participants able to maintain complete abstinence from smoking for the last 4 weeks of treatment, as assessed using multiple imputation analysis. Secondary end points included point prevalence abstinence at 6 months, continuous abstinence rate from weeks 9 through 24, and adverse events. Multiple imputation also was used to address loss to follow-up. The combination treatment was associated with a higher continuous abstinence rate at 12 weeks (55.4% vs 40.9%; odds ratio [OR], 1.85; 95% CI, 1.19-2.89; P = .007) and 24 weeks (49.0% vs 32.6%; OR, 1.98; 95% CI, 1.25-3.14; P = .004) and point prevalence abstinence rate at 6 months (65.1% vs 46.7%; OR, 2.13; 95% CI, 1.32-3.43; P = .002). In the combination treatment group, there was a numerically greater incidence of nausea, sleep
Caponnetto, Pasquale; Polosa, Riccardo; Auditore, Roberta; Minutolo, Giuseppe; Signorelli, Maria; Maglia, Marilena; Alamo, Angela; Palermo, Filippo; Aguglia, Eugenio
2014-03-22
It is well established in studies across several countries that tobacco smoking is more prevalent among schizophrenic patients than the general population. Electronic cigarettes are becoming increasingly popular with smokers worldwide. To date there are no large randomized trials of electronic cigarettes in schizophrenic smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population. We have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. The trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in schizophrenic smokers not intending to quit. We will also monitor quality of life, neurocognitive functioning and measure participants' perception and satisfaction of the product. A ≥50% reduction in the number of cigarettes/day from baseline, will be calculated at each study visit ("reducers"). Abstinence from smoking will be calculated at each study visit ("quitters"). Smokers who leave the study protocol before its completion and will carry out the Early Termination Visit or who will not satisfy the criteria of "reducers" and "quitters" will be defined "non responders". The differences of continuous variables between the three groups will be evaluated with the Kruskal-Wallis Test, followed by the Dunn multiple comparison test. The differences between the three groups for normally distributed data will be evaluated with ANOVA test one way, followed by the Newman-Keuls multiple comparison test. The normality of the distribution will be evaluated with the Kolmogorov-Smirnov test. Any correlations between the variables under evaluation will be assessed by Spearman r correlation. To compare qualitative data will be used the Chi-square test. The main strengths of the SCARIS study are the following: it's the first large RCT on schizophrenic patient, involving in and outpatient
Dennis, Paul A; Kimbrel, Nathan A; Dedert, Eric A; Beckham, Jean C; Dennis, Michelle F; Calhoun, Patrick S
2016-08-01
Individuals with posttraumatic stress disorder (PTSD) are more likely to smoke and more likely to relapse following a quit attempt than individuals without PTSD. Thus, there is a significant need to study promising interventions that might improve quit rates for smokers with PTSD. One such intervention, supplemental nicotine patch-preloading, entails the use of nicotine replacement therapy prior to quitting. Objective The objective of this study was to conduct a randomized controlled trial of the efficacy of supplemental nicotine patch-preloading among smokers with PTSD. We hypothesized that, relative to participants in the placebo condition, participants in the nicotine patch-preloading condition would: (1) smoke less and experience reduced craving for cigarettes during the nicotine patch-preloading phase; (2) experience less smoking-associated relief from PTSD symptoms and negative affect during the preloading phase; and (3) exhibit greater latency to lapse, and higher short- and long-term abstinence rates. Sixty-three smokers with PTSD were randomized to either nicotine or placebo patch for three weeks prior to their quit date. Ecological momentary assessment was used to assess craving, smoking, PTSD symptoms, and negative affect during the preloading period. Nicotine patch-preloading failed to reduce smoking or craving during the preloading phase, nor was it associated with less smoking-associated relief from PTSD symptoms and negative affect. Moreover, no differences were observed between the treatment conditions for time to lapse, 6-week abstinence, or 6-month abstinence. The findings from the present research suggest that supplemental nicotine patch-preloading is unlikely to substantially enhance quit rates among smokers with PTSD. Published by Elsevier Ltd.
Preventing Postpartum Smoking Relapse: A Randomized Clinical Trial.
Levine, Michele D; Cheng, Yu; Marcus, Marsha D; Kalarchian, Melissa A; Emery, Rebecca L
2016-04-01
Most women who quit smoking during pregnancy will relapse postpartum. Previous efforts to prevent postpartum relapse have been unsuccessful at increasing rates of sustained abstinence. To evaluate the relative efficacy of 2 different approaches to prevent postpartum smoking relapse. Pregnant women who recently had quit smoking were recruited before the end of pregnancy. Intervention sessions were conducted through a combination of telephone calls and in-person visits beginning at delivery and continuing through 24 weeks postpartum. Participants completed assessments at the prenatal baseline and at 12, 24, and 52 weeks postpartum. Participants were recruited between March 2008 and December 2012. The dates of the analysis were April 2014 to February 2015. Women received postpartum-adapted, behavioral smoking relapse prevention intervention and were randomly assigned to an enhanced cognitive behavioral intervention that included additional specialized strategies and content focused on women's postpartum concerns about mood, stress, and weight (Strategies to Avoid Returning to Smoking [STARTS]) or a supportive, time and attention-controlled comparison (SUPPORT). Intervention began before delivery and continued through 24 weeks postpartum. The primary outcome was biochemically confirmed sustained tobacco abstinence at 52 weeks postpartum. Secondary outcomes were self-reported mood, levels of perceived stress, and degree of concern about smoking-related weight gain. The study cohort comprised 300 participants (150 randomly assigned to each group). Their mean (SD) age was 24.99 (5.65) years. Overall, 38.0% (114 of 300), 33.7% (101 of 300), and 24.0% (72 of 300) of the sample maintained abstinence at 12, 24, and 52 weeks' postpartum, respectively. There were no differences between the intervention groups in abstinence or time to relapse. Self-reported depressive symptoms and perceived stress significantly improved over time, and improvements were similar for both
Bush, Terry; Lovejoy, Jennifer; Javitz, Harold; Torres, Alula Jimenez; Wassum, Ken; Tan, Marcia M; Spring, Bonnie
2018-05-31
Smoking cessation often results in weight gain which discourages many smokers from quitting and can increase health risks. Treatments to reduce cessation-related weight gain have been tested in highly controlled trials of in-person treatment, but have never been tested in a real-world setting, which has inhibited dissemination. The Best Quit Study (BQS) is a replication and "real world" translation using telephone delivery of a prior in-person efficacy trial. randomized control trial in a quitline setting. Eligible smokers (n = 2540) were randomized to the standard 5-call quitline intervention or quitline plus simultaneous or sequential weight management. Regression analyses tested effectiveness of treatments on self-reported smoking abstinence and weight change at 6 and 12 months. Study enrollees were from 10 commercial employer groups and three state quitlines. Participants were between ages 18-72, 65.8% female, 68.2% white; 23.0% Medicaid-insured, and 76.3% overweight/obese. The follow-up response rate was lower in the simultaneous group than the control group at 6 months (p = 0.01). While a completers analysis of 30-day point prevalence abstinence detected no differences among groups at 6 or 12 months, multiply imputed abstinence showed quit rate differences at 6 months for:simultaneous (40.3%) vs. sequential (48.3%), p = 0.034 and simultaneous vs. control (44.9%), p = 0.043. At 12 months, multiply imputed abstinence, was significantly lower for the simultaneous group (40.7%) vs. control (46.0%), p < 0.05 and vs. sequential (46.3%), p < 0.05. Weight gain at 6 and 12 months was minimal and not different among treatment groups. The sequential group completed fewer total calls (3.75) vs. control (4.16) and vs. simultaneous group (3.83), p = 0.01, and fewer weight calls (0.94) than simultaneous (2.33), p < 0.0001. The number of calls completed predicted 30-day abstinence, p < 0.001, but not weight outcomes. This study
Puttarak, Panupong; Pornpanyanukul, Patarachai; Meetam, Thunyaluk; Bunditanukul, Katha; Chaiyakunapruk, Nathorn
2018-04-01
Several randomized controlled trials have investigated Vernonia cinerea (L.) Less. for smoking cessation but there remains no critical summary of overall findings. This study uses systematic review and meta-analysis to summarize the efficacy and safety of V. cinerea. Nine databases were searched through November 2017. Randomized controlled trials that reported the smoking cessation effect of V. cinerea were included. Data were extracted by two independent researchers. Study quality was assessed using the Cochrane risk of bias and JADAD score. The estimates of pooled effects were calculated as relative risk (RR) with 95% CI using a random-effects model. Five trials with 347 smokers were included. V. cinerea treatment group was significantly associated with cessation rate higher than that in the control group with no evidence of heterogeneity for both continuous abstinence rate (CAR) at week 8 with risk ratio (RR): 1.69, 95% CI [1.00, 2.86]; week 12 RR: 2.18, 95% CI [1.17, 4.04]) and 7-day point prevalence abstinence rate (PAR) (week 8 RR: 1.51, 95% CI [1.01, 2.27]; week 12 RR: 1.93, 95% CI [1.24, 2.99]) at week 8 and 12, respectively. There was no significant difference of all adverse events between the treatment and the control groups. Our study demonstrates that V. cinerea has potential efficacy for smoking cessation. Further well-design RCTs of standardized V. cinerea compared with standard treatment should be conducted to strengthen this evidence. Copyright © 2018 Elsevier Ltd. All rights reserved.
Hypnosis for Smoking Relapse Prevention: A Randomized Trial.
Carmody, Timothy P; Duncan, Carol L; Solkowitz, Sharon N; Huggins, Joy; Simon, Joel A
2017-10-01
The purpose of this study was to determine whether hypnosis would be more effective than standard behavioral counseling in helping smokers to remain abstinent. A total of 140 current smokers were enrolled in a randomized controlled smoking cessation trial at an urban Veterans Affairs medical center. Participants (n = 102) who were able to quit for at least 3 days received either a hypnosis or behavioral relapse prevention intervention. Both relapse prevention interventions consisted of two 60 min face-to-face sessions and four 20 min follow-up phone calls (two phone calls per week). At 26 weeks, the validate\\d point-prevalence quit rate was 35% for the hypnosis group and 42% for the behavioral counseling group (relative risk = 0.85; 95% confidence interval: 0.52-1.40). At 52 weeks, the validated quit rate was 29% for the hypnosis group and 28% for the behavioral group (relative risk = 1.03; 95% confidence interval: 0.56-1.91). It was concluded that hypnosis warrants further investigation as an intervention for facilitating maintenance of quitting.
Gabapentin treatment for alcohol dependence: a randomized clinical trial.
Mason, Barbara J; Quello, Susan; Goodell, Vivian; Shadan, Farhad; Kyle, Mark; Begovic, Adnan
2014-01-01
Approved medications for alcohol dependence are prescribed for less than 9% of US alcoholics. To determine if gabapentin, a widely prescribed generic calcium channel/γ-aminobutyric acid-modulating medication, increases rates of sustained abstinence and no heavy drinking and decreases alcohol-related insomnia, dysphoria, and craving, in a dose-dependent manner. A 12-week, double-blind, placebo-controlled, randomized dose-ranging trial of 150 men and women older than 18 years with current alcohol dependence, conducted from 2004 through 2010 at a single-site, outpatient clinical research facility adjoining a general medical hospital. Oral gabapentin (dosages of 0 [placebo], 900 mg, or 1800 mg/d) and concomitant manual-guided counseling. Rates of complete abstinence and no heavy drinking (coprimary) and changes in mood, sleep, and craving (secondary) over the 12-week study. RESULTS Gabapentin significantly improved the rates of abstinence and no heavy drinking. The abstinence rate was 4.1% (95% CI, 1.1%-13.7%) in the placebo group, 11.1% (95% CI, 5.2%-22.2%) in the 900-mg group, and 17.0% (95% CI, 8.9%-30.1%) in the 1800-mg group (P = .04 for linear dose effect; number needed to treat [NNT] = 8 for 1800 mg). The no heavy drinking rate was 22.5% (95% CI, 13.6%-37.2%) in the placebo group, 29.6% (95% CI, 19.1%-42.8%) in the 900-mg group, and 44.7% (95% CI, 31.4%-58.8%) in the 1800-mg group (P = .02 for linear dose effect; NNT = 5 for 1800 mg). Similar linear dose effects were obtained with measures of mood (F2 = 7.37; P = .001), sleep (F2 = 136; P < .001), and craving (F2 = 3.56; P = .03). There were no serious drug-related adverse events, and terminations owing to adverse events (9 of 150 participants), time in the study (mean [SD], 9.1 [3.8] weeks), and rate of study completion (85 of 150 participants) did not differ among groups. Gabapentin (particularly the 1800-mg dosage) was effective in treating alcohol dependence and relapse-related symptoms of insomnia
Le Grange, Daniel; Lock, James; Agras, W. Stewart; Bryson, Susan W.; Jo, Booil
2015-01-01
Objective There is a paucity of randomized clinical trials (RCTs) for adolescents with bulimia nervosa (BN). Prior studies suggest cognitive-behavioral therapy adapted for adolescents (CBT-A) and family-based treatment (FBT-BN) could be effective for this patient population. The objective of this study was to compare the relative efficacy of these two specific therapies, FBT-BN and CBT-A. In addition, a smaller group was randomized to a non-specific treatment (supportive psychotherapy [SPT]), whose data were to be used if there were no differences between FBT-BN and CBT-A at end of treatment (EOT). Method This two-site RCT (Chicago and Stanford) randomized 130 participants (aged 12–18 years) meeting DSM, 4th Edition criteria for BN or partial BN (binge eating and purging ≥once per week for six months). Outcomes were assessed at baseline, EOT, 6 and 12 months post treatment. Treatments involved 18 outpatient sessions over 6 months. Primary outcome was defined as abstinence from binge eating and purging for 4 weeks prior to assessment, using the Eating Disorder Examination. Results Participants in FBT-BN achieved higher abstinence rates than in CBT-A at EOT (39% vs. 20%; p=.040, number needed to treat [NNT]=5) and at 6-month follow-up (44% vs. 25%; p=.030, NNT=5). Abstinence rates between these two groups did not differ statistically at 12- month follow-up (49% vs. 32%; p=.130, NNT=6). Conclusion FBT-BN is more effective in promoting abstinence from binge eating and purging than CBT-A in adolescent BN at EOT and 6-month follow-up. By 12-month follow-up there were no statistically significant differences between the two treatments. PMID:26506579
Williams, Geoffrey C.; Niemiec, Christopher P.; Patrick, Heather; Ryan, Richard M.; Deci, Edward L.
2010-01-01
Background The Public Health Service (PHS) Guideline for Treating Tobacco Use and Dependence (1) recommends supporting autonomy and perceived competence to facilitate tobacco abstinence. Purpose To evaluate the effectiveness of an intensive tobacco-dependence intervention based on self-determination theory (SDT) and intended to support autonomy and perceived competence in facilitating long-term tobacco abstinence. Methods One thousand and six adult smokers were recruited into a randomized cessation-induction trial. Community care participants received cessation pamphlets and information on local treatment programs. Intervention participants received the same materials and were asked to meet four times with counselors over six months to discuss their health in a manner intended to support autonomy and perceived competence. The primary outcome was 24-month prolonged abstinence from tobacco. The secondary outcome was 7-day point prevalence tobacco abstinence at 24 months post-intervention. Results Smokers in the intervention were more likely to attain both tobacco abstinence outcomes and these effects were partially mediated by change in both autonomous self-regulation and perceived competence from baseline to six months. Structural equation modeling confirmed the SDT model of health-behavior change in facilitating long-term tobacco abstinence. Conclusions An intervention based on SDT and consistent with the PHS Guideline, which was intended to support autonomy and perceived competence, facilitated long-term tobacco abstinence. PMID:19373517
Williams, Geoffrey C; Niemiec, Christopher P; Patrick, Heather; Ryan, Richard M; Deci, Edward L
2009-06-01
The Public Health Service (PHS) Guideline for Treating Tobacco Use and Dependence (Fiore et al. 2000) recommends supporting autonomy and perceived competence to facilitate tobacco abstinence. The aim of the study was to evaluate the effectiveness of an intensive tobacco-dependence intervention based on self-determination theory (SDT) and intended to support autonomy and perceived competence in facilitating long-term tobacco abstinence. One thousand and six adult smokers were recruited into a randomized cessation-induction trial. Community care participants received cessation pamphlets and information on local treatment programs. Intervention participants received the same materials and were asked to meet four times with counselors over 6 months to discuss their health in a manner intended to support autonomy and perceived competence. The primary outcome was 24-month prolonged abstinence from tobacco. The secondary outcome was 7-day point prevalence tobacco abstinence at 24 months postintervention. Smokers in the intervention were more likely to attain both tobacco abstinence outcomes and these effects were partially mediated by change in both autonomous self-regulation and perceived competence from baseline to 6 months. Structural equation modeling confirmed the SDT model of health-behavior change in facilitating long-term tobacco abstinence. An intervention based on SDT and consistent with the PHS Guideline, which was intended to support autonomy and perceived competence, facilitated long-term tobacco abstinence.
A randomized controlled trial of Moderation-Oriented Cue Exposure.
Heather, N; Brodie, J; Wale, S; Wilkinson, G; Luce, A; Webb, E; McCarthy, S
2000-07-01
A randomized controlled trial was conducted to examine the effectiveness of Moderation-Oriented Cue Exposure (MOCE) in comparison to Behavioral Self-Control Training (BSCT). The main hypothesis was that MOCE would be more effective than BSCT among a sample of problem drinkers aiming at moderate drinking. A subsidiary hypothesis was that MOCE would be relatively more effective than BSCT among problem drinkers with higher levels of alcohol dependence. Clients (N = 91; 75% men) were randomly allocated to either MOCE or BSCT. Treatment was delivered in weekly sessions by two trained therapists, in a nested design in which therapists switched to the alternative treatment modality approximately halfway through the trial. Follow-up was carried out 6 months following posttreatment assessment, with 85% successful contact. There was no evidence for the general superiority of MOCE over BSCT. The subsidiary hypothesis was not confirmed. A subsample of clients (n = 14) showing levels of dependence at baseline above the commonly accepted cut-point for a moderation goal (Severity of Alcohol Dependence Questionnaire [SADQ] > 29) showed outcomes at least as favorable as those below the cut-point. The validity of self-reports of alcohol consumption and problems was supported by significant relationships with liver function tests (gamma-glutamyl transferase and alanine transferase). These results provide no grounds for the replacement of BSCT by MOCE in routine, moderation-oriented treatment practice. Assuming they prefer it to abstinence and that it is not contra-indicated on other grounds, there seems no reason why clients showing a higher level of dependence (SADQ = 30-45) should not be offered a moderation goal.
Vaccine for Cocaine Dependence: A Randomized Double-Blind Placebo-Controlled Efficacy Trial
Kosten, Thomas R.; Domingo, Coreen B.; Shorter, Daryl; Orson, Frank; Green, Charles; Somoza, Eugene; Sekerka, Rachelle; Levin, Frances R.; Mariani, John J.; Stitzer, Maxine; Tompkins, D. Andrew; Rotrosen, John; Thakkar, Vatsal; Smoak, Benjamin; Kampman, Kyle
2014-01-01
Aims We evaluated the immunogenicity, efficacy, and safety of succinylnorcocaine conjugated to cholera toxin B protein as a vaccine for cocaine dependence. Methods This 6-site, 24 week Phase III randomized double-blind placebo-controlled trial assessed efficacy during weeks 8 to 16. We measured urine cocaine metabolites thrice weekly as the main outcome. Results The 300 subjects (76% male, 72% African-American, mean age 46 years) had smoked cocaine on average for 13 days monthly at baseline. We hypothesized that retention might be better and positive urines lower for subjects with anti-cocaine IgG levels of ≥ 42 μg/mL (high IgG), which was attained by 67% of the 130 vaccine subjects receiving five vaccinations. Almost 3-times fewer high than low IgG subjects dropped out (7% vs 20%). Although for the full 16 weeks cocaine positive urine rates showed no significant difference between the three groups (placebo, high, low IgG), after week 8, more vaccinated than placebo subjects attained abstinence for at least two weeks of the trial (24% vs 18%), and the high IgG group had the most cocaine-free urines for the last 2 weeks of treatment (OR=3.02), but neither were significant. Injection site reactions of induration and tenderness differed between placebo and active vaccine, and the 29 serious adverse events did not lead to treatment related withdrawals, or deaths. Conclusions The vaccine was safe, but it only partially replicated the efficacy found in the previous study based on retention and attaining abstinence. PMID:24793366
Day, Edward; Copello, Alex; Seddon, Jennifer L; Christie, Marilyn; Bamber, Deborah; Powell, Charlotte; George, Sanju; Ball, Andrew; Frew, Emma; Freemantle, Nicholas
2013-08-19
Research indicates that 3% of people receiving opiate substitution treatment (OST) in the UK manage to achieve abstinence from all prescribed and illicit drugs within 3 years of commencing treatment, and there is concern that treatment services have become skilled at engaging people but not at helping them to enter a stage of recovery and drug abstinence. The National Treatment Agency for Substance Misuse recommends the involvement of families and wider social networks in supporting drug users' psychological treatment, and this pilot randomized controlled trial aims to evaluate the impact of a social network-focused intervention for patients receiving OST. In this two-site, early phase, randomized controlled trial, a total of 120 patients receiving OST will be recruited and randomized to receive one of three treatments: 1) Brief Social Behavior and Network Therapy (B-SBNT), 2) Personal Goal Setting (PGS) or 3) treatment as usual. Randomization will take place following baseline assessment. Participants allocated to receive B-SBNT or PGS will continue to receive the same treatment that is routinely provided by drug treatment services, plus four additional sessions of either intervention. Outcomes will be assessed at baseline, 3 and 12 months. The primary outcome will be assessment of illicit heroin use, measured by both urinary analysis and self-report. Secondary outcomes involve assessment of dependence, psychological symptoms, social satisfaction, motivation to change, quality of life and therapeutic engagement. Family members (n = 120) of patients involved in the trial will also be assessed to measure the level of symptoms, coping and the impact of the addiction problem on the family member at baseline, 3 and 12 months. This study will provide experimental data regarding the feasibility and efficacy of implementing a social network intervention within routine drug treatment services in the UK National Health Service. The study will explore the impact of the
2013-01-01
Background Mobile technology offers the potential to deliver health-related interventions to individuals who would not otherwise present for in-person treatment. Text messaging (short message service, SMS), being the most ubiquitous form of mobile communication, is a promising method for reaching the most individuals. Objective The goal of the present study was to evaluate the feasibility and preliminary efficacy of a smoking cessation intervention program delivered through text messaging. Methods Adult participants (N=60, age range 18-52 years) took part in a single individual smoking cessation counseling session, and were then randomly assigned to receive either daily non-smoking related text messages (control condition) or the TXT-2-Quit (TXT) intervention. TXT consisted of automated smoking cessation messages tailored to individual’s stage of smoking cessation, specialized messages provided on-demand based on user requests for additional support, and a peer-to-peer social support network. Generalized estimating equation analysis was used to assess the primary outcome (7-day point-prevalence abstinence) using a 2 (treatment groups)×3 (time points) repeated measures design across three time points: 8 weeks, 3 months, and 6 months. Results Smoking cessation results showed an overall significant group difference in 7-day point prevalence abstinence across all follow-up time points. Individuals given the TXT intervention, with higher odds of 7-day point prevalence abstinence for the TXT group compared to the Mojo group (OR=4.52, 95% CI=1.24, 16.53). However, individual comparisons at each time point did not show significant between-group differences, likely due to reduced statistical power. Intervention feasibility was greatly improved by switching from traditional face-to-face recruitment methods (4.7% yield) to an online/remote strategy (41.7% yield). Conclusions Although this study was designed to develop and provide initial testing of the TXT-2-Quit system
Abstinence and abstinence-only education: a review of U.S. policies and programs.
Santelli, John; Ott, Mary A; Lyon, Maureen; Rogers, Jennifer; Summers, Daniel; Schleifer, Rebecca
2006-01-01
Abstinence from sexual intercourse is an important behavioral strategy for preventing human immunodeficiency virus (HIV), other sexually transmitted infections (STIs), and pregnancy among adolescents. Many adolescents, including most younger adolescents, have not initiated sexual intercourse and many sexually experienced adolescents and young adults are abstinent for varying periods of time. There is broad support for abstinence as a necessary and appropriate part of sexuality education. Controversy arises when abstinence is provided to adolescents as a sole choice and where health information on other choices is restricted or misrepresented. Although abstinence is theoretically fully effective, in actual practice abstinence often fails to protect against pregnancy and STIs. Few Americans remain abstinent until marriage; many do not or cannot marry, and most initiate sexual intercourse and other sexual behaviors as adolescents. Although abstinence is a healthy behavioral option for teens, abstinence as a sole option for adolescents is scientifically and ethically problematic. A recent emphasis on abstinence-only programs and policies appears to be undermining more comprehensive sexuality education and other government-sponsored programs. We believe that abstinence-only education programs, as defined by federal funding requirements, are morally problematic, by withholding information and promoting questionable and inaccurate opinions. Abstinence-only programs threaten fundamental human rights to health, information, and life.
Barnett, Paul G.; Wong, Wynnie; Jeffers, Abra; Hall, Sharon M.; Prochaska, Judith J.
2016-01-01
Objective We examined the cost-effectiveness of smoking cessation treatment for psychiatric inpatients. Method Smokers, regardless of intention to quit, were recruited during psychiatric hospitalization and randomized to receive stage-based smoking cessation services or usual aftercare. Smoking cessation services, quality of life, and biochemically-verified abstinence from cigarettes were assessed during 18-months of follow-up. Trial findings were combined with literature on changes in smoking status and the age and gender adjusted effect of smoking on health care cost, mortality, and quality of life in a Markov model of cost-effectiveness during a lifetime horizon. Results Among 223 smokers randomized between 2006 and 2008, the mean cost of smoking cessation services was $189 in the experimental treatment group and $37 in the usual care condition (p < 0.001). At the end of follow-up, 18.75% of the experimental group was abstinent from cigarettes, compared to 6.80% abstinence in the usual care group (p <0.05). The model projected that the intervention added $43 in lifetime cost and generated 0.101 additional Quality Adjusted Life Years (QALYs), an incremental cost-effectiveness ratio of $428 per QALY. Probabilistic sensitivity analysis found the experimental intervention was cost-effective against the acceptance criteria of $50,000/QALY in 99.0% of the replicates. Conclusions A cessation intervention for smokers identified in psychiatric hospitalization did not result in higher mental health care costs in the short-run and was highly cost-effective over the long-term. The stage-based intervention was a feasible and cost-effective way of addressing the high smoking prevalence in persons with serious mental illness. PMID:26528651
Cabezas, Carmen; Advani, Mamta; Puente, Diana; Rodriguez-Blanco, Teresa; Martin, Carlos
2011-09-01
To evaluate the effectiveness in primary care of a stepped smoking cessation intervention based on the transtheoretical model of change. Cluster randomized trial; unit of randomization: basic care unit (family physician and nurse who care for the same group of patients); and intention-to-treat analysis. All interested basic care units (n = 176) that worked in 82 primary care centres belonging to the Spanish Preventive Services and Health Promotion Research Network in 13 regions of Spain. A total of 2,827 smokers (aged 14-85 years) who consulted a primary care centre for any reason, provided written informed consent and had valid interviews. The outcome variable was the 1-year continuous abstinence rate at the 2-year follow-up. The main variable was the study group (intervention/control). Intervention involved 6-month implementation of recommendations from a Clinical Practice Guideline which included brief motivational interviews for smokers at the precontemplation-contemplation stage, brief intervention for smokers in preparation-action who do not want help, intensive intervention with pharmacotherapy for smokers in preparation-action who want help and reinforcing intervention in the maintenance stage. Control group involved usual care. Among others, characteristics of tobacco use and motivation to quit variables were also collected. The 1-year continuous abstinence rate at the 2-year follow-up was 8.1% in the intervention group and 5.8% in the control group (P = 0.014). In the multivariate logistic regression, the odds of quitting of the intervention versus control group was 1.50 (95% confidence interval = 1.05-2.14). A stepped smoking cessation intervention based on the transtheoretical model significantly increased smoking abstinence at a 2-year follow-up among smokers visiting primary care centres. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.
Dennis, Paul A.; Kimbrel, Nathan A.; Dedert, Eric A.; Beckham, Jean C.; Dennis, Michelle F.; Calhoun, Patrick S.
2016-01-01
Background Individuals with posttraumatic stress disorder (PTSD) are more likely to smoke and more likely to relapse following a quit attempt than individuals without PTSD. Thus, there is a significant need to study promising interventions that might improve quit rates for smokers with PTSD. One such intervention, supplemental nicotine patch-preloading, entails the use of nicotine replacement therapy prior to quitting. Objective The objective of this study was to conduct a randomized controlled trial of the efficacy of supplemental nicotine patch-preloading among smokers with PTSD. We hypothesized that, relative to participants in the placebo condition, participants in the nicotine patch-preloading condition would: (1) smoke less and experience reduced craving for cigarettes during the nicotine patch-preloading phase; (2) experience less smoking-associated relief from PTSD symptoms and negative affect during the preloading phase; and (3) exhibit greater latency to lapse, and higher short- and long-term abstinence rates. Methods Sixty-three smokers with PTSD were randomized to either nicotine or placebo patch for three weeks prior to their quit date. Ecological momentary assessment was used to assess craving, smoking, PTSD symptoms, and negative affect during the preloading period. Results Nicotine patch-preloading failed to reduce smoking or craving during the preloading phase, nor was it associated with less smoking-associated relief from PTSD symptoms and negative affect. Moreover, no differences were observed between the treatment conditions for time to lapse, 6-week abstinence, or 6-month abstinence. Conclusions The findings from the present research suggest that supplemental nicotine patch-preloading is unlikely to substantially enhance quit rates among smokers with PTSD. PMID:27046670
... Jobs Sports Expert Answers (Q&A) Staying Safe Videos for Educators Search English Español Abstinence KidsHealth / For Teens / Abstinence Print en español La abstinencia sexual What Is It? Abstinence is not having sex. A person who decides to practice abstinence has ...
de Vries, Hein; Hoving, Ciska
2012-01-01
Background Distributing a multiple computer-tailored smoking cessation intervention through the Internet has several advantages for both provider and receiver. Most important, a large audience of smokers can be reached while a highly individualized and personal form of feedback can be maintained. However, such a smoking cessation program has yet to be developed and implemented in the Netherlands. Objective To investigate the effects of a Web-based multiple computer-tailored smoking cessation program on smoking cessation outcomes in a sample of Dutch adult smokers. Methods Smokers were recruited from December 2009 to June 2010 by advertising our study in the mass media and on the Internet. Those interested and motivated to quit smoking within 6 months (N = 1123) were randomly assigned to either the experimental (n = 552) or control group (n = 571). Respondents in the experimental group received the fully automated Web-based smoking cessation program, while respondents in the control group received no intervention. After 6 weeks and after 6 months, we assessed the effect of the intervention on self-reported 24-hour point prevalence abstinence, 7-day point prevalence abstinence, and prolonged abstinence using logistic regression analyses. Results Of the 1123 respondents, 449 (40.0%) completed the 6-week follow-up questionnaire and 291 (25.9%) completed the 6-month follow-up questionnaire. We used a negative scenario to replace missing values. That is, we considered respondents lost to follow-up to still be smoking. The computer-tailored program appeared to have significantly increased 24-hour point prevalence abstinence (odds ratio [OR] 1.85, 95% confidence interval [CI] 1.30–2.65), 7-day point prevalence abstinence (OR 2.17, 95% CI 1.44–3.27), and prolonged abstinence (OR 1.99, 95% CI 1.28–3.09) rates reported after 6 weeks. After 6 months, however, no intervention effects could be identified. Results from complete-case analyses were similar. Conclusions The
Cabezón, Carlos; Vigil, Pilar; Rojas, Iván; Leiva, M Eugenia; Riquelme, Rosa; Aranda, Waldo; García, Carlos
2005-01-01
To evaluate the efficacy of an abstinence-centered sex education program in adolescent pregnancy prevention, the TeenSTAR Program was applied in a high school in Santiago, Chile. A total of 1259 girls from a Santiago high school were divided into three cohorts depending on the year they started high school: the 1996 cohort of 425 students, which received no intervention; the 1997 cohort, in which 210 students received an intervention and 213 (control group) did not; and the 1998 cohort, in which 328 students received an intervention and 83 (control group) did not. Students were randomly assigned to control and intervention groups in these cohorts, before starting with the program. We conducted a prospective, randomized study using the application of the TeenSTAR sex education program during the first year of high school to the intervention groups in the 1997 and 1998 cohorts. All cohorts were followed up for 4 years; pregnancy rates were recorded and subsequently contrasted in the intervention and control groups. Pregnancy rates were measured and Risk Ratio with 95% confidence interval were calculated for intervention and control groups in each cohort. Pregnancy rates for the intervention and control groups in the 1997 cohort were 3.3% and 18.9%, respectively (RR: 0.176, CI: 0.076-0.408). Pregnancy rates for the intervention and control groups in the 1998 cohort were 4.4% and 22.6%, respectively (RR 0.195, CI: 0.099-0.384). The abstinence-centered TeenSTAR sex education intervention was effective in the prevention of unintended adolescent pregnancy.
Littlewood, Rae A; Claus, Eric D; Wilcox, Claire E; Mickey, Jessica; Arenella, Pamela B; Bryan, Angela D; Hutchison, Kent E
2017-12-01
Varenicline has gained a reputation as the optimal intervention for treatment resistant smokers, yet more than half of those who try it do not succeed. To better understand individual differences in the effectiveness of varenicline, this study evaluates the effectiveness of varenicline for smoking cessation in a double-blind, placebo-controlled, randomized clinical trial and examines the influence of psychological factors on treatment outcome. Two hundred five cigarette smokers interested in quitting were randomly assigned to 12 weeks of varenicline or placebo. Outcomes examined were CO-confirmed continuous abstinence for the past month, average number of cigarettes smoked per day, and 7-day point prevalence. Varenicline-treated participants were more likely than placebo to achieve continuous abstinence at the end of treatment (OR = 3.29; RR = 2.62), and 7-day point prevalence rates showed an effect of medication at each time point. Participants in both groups significantly reduced their smoking during the course of treatment and follow-up, and the medication by visit interaction was significant in the expected direction. Impulsivity and personality style emerged as moderators of the relationship between medication condition and treatment outcome. In addition to replicating efficacy results for varenicline versus placebo, the present study shows that the efficacy of pharmacotherapy is influenced by psychological factors. In an era where pharmacotherapy is often perceived as the "silver bullet," we are reminded that smoking cessation is a dynamic process and intervention must be adaptable to address individual differences.
Forced smoking abstinence: not enough for smoking cessation.
Clarke, Jennifer G; Stein, L A R; Martin, Rosemarie A; Martin, Stephen A; Parker, Donna; Lopes, Cheryl E; McGovern, Arthur R; Simon, Rachel; Roberts, Mary; Friedman, Peter; Bock, Beth
2013-05-13
Millions of Americans are forced to quit smoking as they enter tobacco-free prisons and jails, but most return to smoking within days of release. Interventions are needed to sustain tobacco abstinence after release from incarceration. To evaluate the extent to which the WISE intervention (Working Inside for Smoking Elimination), based on motivational interviewing (MI) and cognitive behavioral therapy (CBT), decreases relapse to smoking after release from a smoke-free prison. Participants were recruited approximately 8 weeks prior to their release from a smoke-free prison and randomized to 6 weekly sessions of either education videos (control) or the WISE intervention. A tobacco-free prison in the United States. A total of 262 inmates (35% female). Continued smoking abstinence was defined as 7-day point-prevalence abstinence validated by urine cotinine measurement. At the 3-week follow-up, 25% of participants in the WISE intervention (31 of 122) and 7% of the control participants (9 of 125) continued to be tobacco abstinent (odds ratio [OR], 4.4; 95% CI, 2.0-9.7). In addition to the intervention, Hispanic ethnicity, a plan to remain abstinent, and being incarcerated for more than 6 months were all associated with increased likelihood of remaining abstinent. In the logistic regression analysis, participants randomized to the WISE intervention were 6.6 times more likely to remain tobacco abstinent at the 3-week follow up than those randomized to the control condition (95% CI, 2.5-17.0). Nonsmokers at the 3-week follow-up had an additional follow-up 3 months after release, and overall 12% of the participants in the WISE intervention (14 of 122) and 2% of the control participants (3 of 125) were tobacco free at 3 months, as confirmed by urine cotinine measurement (OR, 5.3; 95% CI, 1.4-23.8). Forced tobacco abstinence alone during incarceration has little impact on postrelease smoking status. A behavioral intervention provided prior to release greatly improves cotinine
Effect of varying levels of disease management on smoking cessation: a randomized trial.
Ellerbeck, Edward F; Mahnken, Jonathan D; Cupertino, A Paula; Cox, Lisa Sanderson; Greiner, K Allen; Mussulman, Laura M; Nazir, Niaman; Shireman, Theresa I; Resnicow, Kenneth; Ahluwalia, Jasjit S
2009-04-07
Cigarette smoking is a chronic, relapsing illness that is inadequately addressed in primary care practice. To compare cessation rates among smokers who receive pharmacotherapy alone or combined with either moderate- or high-intensity disease management that includes counseling and provider feedback. Randomized clinical trial from June 2004 to December 2007. 50 rural primary care practices. 750 persons who smoke more than 10 cigarettes per day. Pharmacotherapy alone (n = 250), pharmacotherapy supplemented with up to 2 counseling calls (moderate-intensity disease management) (n = 249), or pharmacotherapy supplemented with up to 6 counseling calls (high-intensity disease management) (n = 251). Interventions were offered every 6 months for 2 years. All participants were offered free pharmacotherapy. Moderate-intensity and high-intensity disease management recipients had postcounseling progress reports faxed to their physicians. Self-reported, point-prevalence smoking abstinence at 24 months (primary outcome) and overall (0 to 24 months) analyses of smoking abstinence, utilization of pharmacotherapy, and discussions about smoking with physicians (secondary outcomes). Research assistants who were blinded to treatment assignment conducted outcome assessments. Pharmacotherapy utilization was similar across treatment groups, with 473 of 741 (63.8%), 302 of 739 (40.9%), 175 of 732 (23.9%), and 179 of 726 (24.7%) participants requesting pharmacotherapy during the first, second, third, and fourth 6-month treatment cycles, respectively. Of participants who saw a physician during any given treatment cycle, 37.5% to 59.5% reported that they had discussed smoking cessation with their physician; this did not differ across the treatment groups. Abstinence rates increased throughout the study, and overall (0 to 24 months) analyses demonstrated higher abstinence among the high-intensity disease management group than the moderate-intensity disease management group (odds ratio [OR], 1
Shuter, Jonathan; Morales, Daniela A; Considine-Dunn, Shannon E; An, Lawrence C; Stanton, Cassandra A
2014-09-01
To evaluate the feasibility and preliminary efficacy of a Web-based tobacco treatment for persons living with HIV (PLWH). Prospective, randomized controlled trial. HIV-care center in the Bronx, New York. Eligibility criteria included HIV infection, current tobacco usage, interest in quitting, and access to a computer with internet. One hundred thirty-eight subjects enrolled, and 134 completed the study. Positively Smoke Free on the Web (PSFW), an 8-session, 7-week targeted tobacco treatment program for PLWH, was compared with standard care (brief advice to quit and self-help brochure). All subjects were offered nicotine patches. The main feasibility outcomes were number of sessions logged into, number of Web pages visited, number of interactive clicks, and total time logged in. The main efficacy outcome was biochemically verified, 7-day point prevalence abstinence 3 months after intervention. PSFW subjects logged into a mean of 5.5 of 8 sessions and 26.2 of 41 pages. They executed a mean of 10 interactive clicks during a mean total of 59.8 minutes logged in. Most required reminder phone calls to complete the sessions. Educational level, anxiety score, and home access of the Web site were associated with Web site usage. Ten percent of the PSFW group vs. 4.3% of controls achieved the abstinence end point. Among those who completed all 8 sessions, 17.9% were abstinent, and among women completers, 30.8% were abstinent. Web-based treatment is a feasible strategy for PLWH smokers, and preliminary findings suggest therapeutic efficacy.
Watson, Hunna J; McLagan, Nicole; Zerwas, Stephanie C; Crosby, Ross D; Levine, Michele D; Runfola, Cristin D; Peat, Christine M; Moessner, Markus; Zimmer, Benjamin; Hofmeier, Sara M; Hamer, Robert M; Marcus, Marsha D; Bulik, Cynthia M; Crow, Scott J
To evaluate the cost-effectiveness of Internet-based cognitive-behavioral therapy for bulimia nervosa (CBT-BN) compared to face-to-face delivery of CBT-BN. This study is a planned secondary analysis of data from a randomized clinical trial. Participants were 179 adults (98% female, mean age = 28 years) meeting DSM-IV criteria for bulimia nervosa who were randomized to group face-to-face or group Internet-based CBT-BN for 16 sessions during 20 weeks. The cost-effectiveness analysis was conducted from a third-party payor perspective, and a partial societal perspective analysis was conducted to investigate cost-utility (ie, cost per gain in quality-adjusted life-years) and patient out-of-pocket travel-related costs. Net health care costs were calculated from protocol and nonprotocol health care services using third-party payor cost estimates. The primary outcome measure in the clinical trial was abstinence from binge eating and purging, and the trial start and end dates were 2008 and 2016. The mean cost per abstinent patient at posttreatment was $7,757 (95% confidence limit [CL], $4,515, $13,361) for face-to-face and $11,870 (95% CL, $6,486, $22,188) for Internet-based CBT-BN, and at 1-year follow-up was $16,777 (95% CL, $10,298, $27,042) for face-to-face and $14,561 (95% CL, $10,165, $21,028) for Internet-based CBT-BN. There were no statistically significant differences between treatment arms in cost-effectiveness or cost-utility at posttreatment or 1-year follow-up. Out-of-pocket patient costs were significantly higher for face-to-face (mean [95% CL] = $178 [$127, $140]) than Internet-based ($50 [$50, $50]) therapy. Third-party payor cost-effectiveness of Internet-based CBT-BN is comparable with that of an accepted standard. Internet-based dissemination of CBT-BN may be a viable alternative for patients geographically distant from specialist eating disorder services who have an unmet need for treatment. ClinicalTrials.gov identifier: NCT00877786. © Copyright
ERIC Educational Resources Information Center
Veldheer, Susan; Hrabovsky, Shari; Yingst, Jessica; Sciamanna, Chris; Berg, Arthur; Foulds, Jonathan
2018-01-01
Background: Identifying effective relapse prevention interventions is a vital step to help smokers maintain abstinence for the long term. Aims: The purpose of this study is to determine if providing recently quit smokers with self-directed relapse prevention booklets is effective at maintaining abstinence after intensive group smoking cessation…
Effects of Large Financial Incentives for Long-Term Smoking Cessation: A Randomized Trial.
Etter, Jean-François; Schmid, Felicia
2016-08-23
It is not known whether large financial incentives enhance long-term smoking cessation rates outside clinical or workplace settings. The goal of this study was to test whether large financial incentives improved long-term smoking cessation rates in low-income smokers, in a general population setting, without face-to-face or telephone counseling. This was a 2-arm, parallel group, individually randomized controlled trial, with follow-up after 3, 6, and 18 months. Participants were 805 low-income smokers enrolled between 2011 and 2013 from the general population in Geneva, Switzerland. We randomly assigned participants to receive either booklets plus access to a smoking cessation website (control group, n = 404), or the same intervention plus financial incentives (intervention group, n = 401). Incremental financial rewards, to a maximum of U.S. $1,650, were offered for biochemically verified abstinence at 1, 2, and 3 weeks, and 1, 3, and 6 months. No in-person counseling, telephone counseling, or medications were provided. The primary outcome was continuous abstinence between 6 months (end of incentives) and 18 months (12 months after the incentives ended), verified by expired carbon monoxide and salivary cotinine. We also assessed biochemically verified 7-day abstinence at 3, 6, and 18 months. Rates of continuous abstinence between months 6 and 18 were 9.5% in the incentive group and 3.7% in the control group (p = 0.001). Rates of 7-day abstinence were higher in the incentive group than in the control group at 3 (54.9% vs. 11.9%; p < 0.001), 6 (44.6% vs. 11.1%; p < 0.001), and 18 months (18.2% vs. 11.4%; p = 0.006). In low-income smokers who did not receive face-to-face or telephone smoking cessation counseling, large financial incentives increased long-term rates of smoking cessation. (Financial incentives for smoking cessation in low-income smokers; ISRCTN04019434). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All
Lee, Nicole K; Pohlman, Sonja; Baker, Amanda; Ferris, Jason; Kay-Lambkin, Frances
2010-04-01
Craving is frequently reported as a trigger for relapse by those trying to remain abstinent from psychoactive substances. Metacognitive beliefs about managing craving may play an important role in determining further cognition and behavior. They are, therefore, important to measure in treatment and may serve as target cognitions to be modified in support of behavioral change. As part of the assessment battery of a randomized controlled trial among 214 methamphetamine users, we included the Craving Beliefs Questionnaire (CBQ), a measure designed to assess an individual's perception of the potential negative impact of craving, at baseline. Changes in abstinence rates were significantly related to CBQ score, suggesting that craving beliefs are associated with changes in methamphetamine use. Further validation of the CBQ is warranted. Future clinical research among methamphetamine users could focus on directly manipulating craving beliefs through cognitive therapy to affect abstinence. Copyright 2010 Elsevier Inc. All rights reserved.
Fittig, Eike; Trockel, Mickey; Braks, Karsten; Schade-Brittinger, Carmen; Dempfle, Astrid
2017-01-01
Background Relapse rates in bulimia nervosa (BN) are high even after successful treatment, but patients often hesitate to take up further treatment. An easily accessible program might help maintain treatment gains. Encouraged by the effects of Web-based eating disorder prevention programs, we developed a manualized, Web-based aftercare program (IN@) for women with BN following inpatient treatment. Objective The objective of this study was to determine the efficacy of the web-based guided, 9-month, cognitive-behavioral aftercare program IN@ for women with BN following inpatient treatment. Methods We conducted a randomized controlled efficacy trial in 253 women with DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, fourth edition) BN and compared the results of IN@ with treatment as usual (TAU). Assessments were carried out at hospital admission (T0), hospital discharge/baseline (T1), postintervention (T2; 9 months after baseline), 9-month follow-up (T3; 18 months after baseline). The primary outcome, abstinence from binge eating and compensatory behaviors during the 2 months preceding T2, was analyzed by intention to treat, using logistic regression analyses. Frequencies of binge eating and vomiting episodes, and episodes of all compensatory behaviors were analyzed using mixed effects models. Results At T2, data from 167 women were available. There were no significant differences in abstinence rates between the TAU group (n=24, 18.9%) and the IN@ group (n=27, 21.4%; odds ratio, OR=1.29; P=.44). The frequency of vomiting episodes in the IN@ group was significantly (46%) lower than in the TAU group (P=.003). Moderator analyses revealed that both at T2 and T3, women of the intervention group who still reported binge eating and compensatory behaviors after inpatient treatment benefited from IN@, whereas women who were already abstinent after the inpatient treatment did not (P=.004; P=.002). Additional treatment utilization was high in both groups between
Holtyn, August F; Koffarnus, Mikhail N; DeFulio, Anthony; Sigurdsson, Sigurdur O; Strain, Eric C; Schwartz, Robert P; Silverman, Kenneth
2014-01-01
We examined the use of employment-based abstinence reinforcement in out-of-treatment injection drug users, in this secondary analysis of a previously reported trial. Participants (N = 33) could work in the therapeutic workplace, a model employment-based program for drug addiction, for 30 weeks and could earn approximately $10 per hr. During a 4-week induction, participants only had to work to earn pay. After induction, access to the workplace was contingent on enrollment in methadone treatment. After participants met the methadone contingency for 3 weeks, they had to provide opiate-negative urine samples to maintain maximum pay. After participants met those contingencies for 3 weeks, they had to provide opiate- and cocaine-negative urine samples to maintain maximum pay. The percentage of drug-negative urine samples remained stable until the abstinence reinforcement contingency for each drug was applied. The percentage of opiate- and cocaine-negative urine samples increased abruptly and significantly after the opiate- and cocaine-abstinence contingencies, respectively, were applied. These results demonstrate that the sequential administration of employment-based abstinence reinforcement can increase opiate and cocaine abstinence among out-of-treatment injection drug users. © Society for the Experimental Analysis of Behavior.
Holtyn, August F.; Koffarnus, Mikhail N.; DeFulio, Anthony; Sigurdsson, Sigurdur O.; Strain, Eric C.; Schwartz, Robert P.; Silverman, Kenneth
2016-01-01
We examined the use of employment-based abstinence reinforcement in out-of-treatment injection drug users, in this secondary analysis of a previously reported trial. Participants (N = 33) could work in the therapeutic workplace, a model employment-based program for drug addiction, for 30 weeks and could earn approximately $10 per hr. During a 4-week induction, participants only had to work to earn pay. After induction, access to the workplace was contingent on enrollment in methadone treatment. After participants met the methadone contingency for 3 weeks, they had to provide opiate-negative urine samples to maintain maximum pay. After participants met those contingencies for 3 weeks, they had to provide opiate- and cocaine-negative urine samples to maintain maximum pay. The percentage of drug-negative urine samples remained stable until the abstinence reinforcement contingency for each drug was applied. The percentage of opiate- and cocaine-negative urine samples increased abruptly and significantly after the opiate- and cocaine-abstinence contingencies, respectively, were applied. These results demonstrate that the sequential administration of employment-based abstinence reinforcement can increase opiate and cocaine abstinence among out-of-treatment injection drug users. PMID:25292399
Oesterle, Sabrina; Hawkins, J David; Kuklinski, Margaret R; Fagan, Abigail A; Fleming, Christopher; Rhew, Isaac C; Brown, Eric C; Abbott, Robert D; Catalano, Richard F
2015-12-01
This study tested sustained effects of the Communities That Care (CTC) prevention system on health-risking behaviors 9 years after baseline in a community-randomized trial involving 24 towns in seven states. Earlier analyses found sustained effects on abstinence from drug use and delinquency through Grade 12 in a panel of fifth graders. At age 19, 91 % (n = 3986) of the living panel completed the survey. Data were analyzed using generalized linear mixed models. The prevalence of lifetime and current substance use and delinquency were the primary outcomes. Secondary outcomes included substance use disorders, major depression, suicidality, educational attainment, and sexual risk behaviors. CTC had a significant overall effect across lifetime measures of the primary outcomes for males, but not for females or the full sample, although lifetime abstinence from delinquency in the full sample was significantly higher in CTC communities (ARR = 1.16). Males in CTC communities also continued to show greater lifetime abstinence from cigarette smoking (ARR = 1.22). CTC did not have a sustained effect on current substance use and delinquency nor did it improve the secondary outcomes at age 19 for either gender. Communities using CTC may need to extend their prevention planning to include the high school years to sustain effects on drug use and delinquency beyond high school for both genders. ClinicalTrials.gov identifier: NCT01088542.
A randomized placebo-controlled clinical trial of five smoking cessation pharmacotherapies
Piper, Megan E.; Smith, Stevens S.; Schlam, Tanya R.; Fiore, Michael C.; Jorenby, Douglas E.; Fraser, David; Baker, Timothy B.
2010-01-01
Context Little direct evidence exists on the relative efficacies of different smoking cessation pharmacotherapies, yet such evidence is needed to make informed decisions about their clinical use. Objective The primary objective of this research was to assess the relative efficacies of five smoking cessation pharmacotherapy interventions using placebo-controlled, head-to-head comparisons. Design This was a randomized double-blind, placebo-controlled clinical trial. Setting Smokers were recruited from the community at two urban research sites. Patients Participants were 1504 adult smokers who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit smoking. Participants were excluded if they reported: using any form of tobacco other than cigarettes; current use of bupropion; having a current psychosis or schizophrenia diagnosis; or having medical contraindications for any of the study medications. Interventions Participants were randomized to one of six treatment conditions: nicotine lozenge, nicotine patch, bupropion SR, nicotine patch + nicotine lozenge, bupropion + nicotine lozenge or placebo. In addition, all participants received six individual counseling sessions. Main Outcome Measures The main outcome measures were biochemically-confirmed 7-day point-prevalence abstinence assessed at 1 week post-quit, end of treatment (8 weeks post-quit) and 6 months post-quit. Other outcomes were initial cessation, number of days to lapse, number of days to relapse, and latency to relapse after the first lapse. Results All pharmacotherapies differed from placebo when examined without protection for multiple comparisons (OR’s = 1.63–2.34). With such protection, only the nicotine patch + nicotine lozenge (OR = 2.34, p < .001) produced significantly higher abstinence rates at 6-months post-quit than did placebo. Conclusions While the nicotine lozenge, bupropion, and bupropion + lozenge produced effects that were comparable to those
Behavioral cessation treatment of waterpipe smoking: The first pilot randomized controlled trial
Asfar, Taghrid; Ali, Radwan Al; Rastam, Samer; Maziak, Wasim; Ward, Kenneth D.
2014-01-01
Background Waterpipe use has increased dramatically in the Middle East and other parts of the world. Many users exhibit signs of dependence, including withdrawal and difficulty quitting, but there is no evidence base to guide cessation efforts. Methods We developed a behavioral cessation program for willing-to-quit waterpipe users, and evaluated its feasibility and efficacy in a pilot, two arm, parallel group, randomized, open label trial in Aleppo, Syria. Fifty adults who smoked waterpipe ≥3 times per week in the last year, did not smoke cigarettes, and were interested in quitting were randomized to receive either brief (1 in-person session and 3 phone calls) or intensive (3 in-person sessions and 5 phone calls) behavioral cessation treatment delivered by a trained physician in a clinical setting. The primary efficacy end point of the developed interventions was prolonged abstinence at three months post-quit day, assessed by self-report and exhaled carbon monoxide levels of <10 ppm. Secondary end points were 7 day point-prevalent abstinence and adherence to treatment. Results Thirty percent of participants were fully adherent to treatment, which did not vary by treatment group. The proportions of participants in the brief and intensive interventions with prolonged abstinence at the 3-month assessment were 30.4% and 44.4%, respectively. Previous success in quitting (OR = 3.57; 95% CI = 1.03–12.43) predicted cessation. Higher baseline readiness to quit, more confidence in quitting, and being unemployed predicted a better adherence to treatment (all p-values <0.05). Conclusions Brief behavioral cessation treatment for waterpipe users appears to be feasible and effective. PMID:24629480
Sherman, Scott E; Link, Alissa R; Rogers, Erin S; Krebs, Paul; Ladapo, Joseph A; Shelley, Donna R; Fang, Yixin; Wang, Binhuan; Grossman, Ellie
2016-10-01
Hospitalization is a unique opportunity for smoking cessation, but prior interventions have measured efficacy with narrowly defined populations. The objective of this study was to enroll smokers admitted to two "safety net" hospitals and compare the effectiveness of two post-discharge cessation interventions. A randomized comparative effectiveness trial was conducted. At two New York City public hospitals, every hospitalized patient identified as a smoker (based on admission records) was approached. Inclusion criteria were: smoked cigarettes in the past 30 days; spoke English, Spanish, or Mandarin; had a U.S. phone number; not discharged to an institution where follow-up or smoking was limited; and not pregnant/breastfeeding. Of 18,797 patients identified as current smokers between July 2011 and April 2014, a total of 3,047 (16%) were discharged before being approached, 3,273 (17%) were not current smokers, 4,026 (21%) had no U.S. phone number, 2,831 (15%) were ineligible for other reasons, and 3,983 (21%) refused participation. In total, 1,618 (9%) participants enrolled in the study. During follow-up, 69% of participants were reached at 2 months and 68% at 6 months. At discharge, participants were randomized to multisession telephone counseling from study staff (n=804) or referral to the state quitline for proactive outreach and counseling (n=814). Self-reported abstinence at 6 months was measured. Analyses were conducted in late 2015. One quarter of participants were homeless or in unstable housing, 60% had a history of substance abuse, 43% reported current hazardous drinking, and half had a psychiatric diagnosis other than substance abuse. At follow-up, the rate of abstinence (30-day point prevalence) was higher in the intensive counseling arm than the quitline arm at 2 months (29.0% vs 20.7%; relative risk=1.40; 95% CI=1.13, 1.73) and 6 months (37.4% vs 31.5%; relative risk=1.19; 95% CI=1.01, 1.40). Intensive counseling was more effective than referral to the
Gonzales, D; Hajek, P; Pliamm, L; Nackaerts, K; Tseng, L-J; McRae, T D; Treadow, J
2014-01-01
The efficacy and safety of retreatment with varenicline in smokers attempting to quit were evaluated in this randomized, double-blind, placebo-controlled, multicenter trial (Australia, Belgium, Canada, the Czech Republic, France, Germany, the United Kingdom, and the United States). Participants were generally healthy adult smokers (≥10 cigarettes/day) with ≥1 prior quit attempt (≥2 weeks) using varenicline and no quit attempts in ≤3 months; they were randomly assigned (1:1) to 12 weeks' varenicline (n = 251) or placebo (n = 247) treatment, with individual counseling, plus 40 weeks' nontreatment follow-up. The primary efficacy end point was the carbon monoxide–confirmed (≤10 ppm) continuous abstinence rate for weeks 9–12, which was 45.0% (varenicline; n = 249) vs. 11.8% (placebo; n = 245; odds ratio: 7.08; 95% confidence interval: 4.34, 11.55; P < 0.0001). Common varenicline group adverse events were nausea, abnormal dreams, and headache, with no reported suicidal behavior. Varenicline is efficacious and well tolerated in smokers who have previously taken it. Abstinence rates are comparable with rates reported for varenicline-naive smokers. PMID:24911368
Fellows, Jeffrey L; Mularski, Richard; Waiwaiole, Lisa; Funkhouser, Kim; Mitchell, Julie; Arnold, Kathleen; Luke, Sabrina
2012-08-01
Extended smoking cessation follow-up after hospital discharge significantly increases abstinence. Hospital smoke-free policies create a period of 'forced abstinence' for smokers, thus providing an opportunity to integrate tobacco dependence treatment, and to support post-discharge maintenance of hospital-acquired abstinence. This study is funded by the National Heart, Lung, and Blood Institute (1U01HL1053231). The Inpatient Technology-Supported Assisted Referral study is a multi-center, randomized clinical effectiveness trial being conducted at Kaiser Permanente Northwest (KPNW) and at Oregon Health & Science University (OHSU) hospitals in Portland, Oregon. The study assesses the effectiveness and cost-effectiveness of linking a practical inpatient assisted referral to outpatient cessation services plus interactive voice recognition (AR + IVR) follow-up calls, compared to usual care inpatient counseling (UC). In November 2011, we began recruiting 900 hospital patients age ≥18 years who smoked ≥1 cigarettes in the past 30 days, willing to remain abstinent postdischarge, have a working phone, live within 50 miles of the hospital, speak English, and have no health-related barriers to participation. Each site will randomize 450 patients to AR + IVR or UC using a 2:1 assignment strategy. Participants in the AR + IVR arm will receive a brief inpatient cessation consult plus a referral to available outpatient cessation programs and medications, and four IVR follow-up calls over seven weeks postdischarge. Participants do not have to accept the referral. At KPNW, UC participants will receive brief inpatient counseling and encouragement to self-enroll in available outpatient services. The primary outcome is self-reported thirty-day smoking abstinence at six months postrandomization for AR + IVR participants compared to usual care. Additional outcomes include self-reported and biochemically confirmed seven-day abstinence at six months, self-reported seven
Levin, Frances R; Mariani, John; Brooks, Daniel J; Pavlicova, Martina; Nunes, Edward V; Agosti, Vito; Bisaga, Adam; Sullivan, Maria A; Carpenter, Kenneth M
2013-06-01
To evaluate whether venlafaxine-extended release (VEN-XR) is an effective treatment for cannabis dependence with concurrent depressive disorders. This was a randomized, 12-week, double-blind, placebo-controlled trial of out-patients (n = 103) with DSM-IV cannabis dependence and major depressive disorder or dysthymia. Participants received up to 375 mg VEN-XR on a fixed-flexible schedule or placebo. All patients received weekly individual cognitive-behavioral psychotherapy that primarily targeted marijuana use. The trial was conducted at two university research centers in the United States. One hundred and three cannabis-dependent adults participated in the trial. The primary outcome measures were (i) abstinence from marijuana defined as at least two consecutive urine-confirmed abstinent weeks and (ii) improvement in depressive symptoms based on the Hamilton Depression Rating Scale. The proportion of patients achieving a clinically significant mood improvement (50% decrease in Hamilton Depression score from baseline) was high and did not differ between groups receiving VEN-XR (63%) and placebo (69%) (χ1 (2) = 0.48, P = 0.49). The proportion of patients achieving abstinence was low overall, but was significantly worse on VEN-XR (11.8%) compared to placebo (36.5%) (χ1 (2) = 7.46, P < 0.01; odds ratio = 4.51, 95% confidence interval: 1.53, 13.3). Mood improvement was associated with reduction in marijuana use in the placebo group (F1,179 = 30.49, P < 0.01), but not the VEN-XR group (F1,186 = 0.02, P = 0.89). For depressed, cannabis-dependent patients, venlafaxine-extended release does not appear to be effective at reducing depression and may lead to an increase in cannabis use. © 2013 Society for the Study of Addiction.
Levin, Frances R.; Mariani, John; Brooks, Daniel J.; Pavlicova, Martina; Nunes, Edward V.; Agosti, Vito; Bisaga, Adam; Sullivan, Maria A.; Carpenter, Kenneth M.
2013-01-01
Aim To evaluate whether venlafaxine-extended release (VEN-XR) is an effective treatment for cannabis dependence with concurrent depressive disorders. Design This was a randomized, 12 week, double-blind, placebo-controlled trial of outpatients (n = 103) with DSM-IV cannabis dependence and major depressive disorder or dysthymia. Participants received up to 375 mg VEN-XR on a fixed-flexible schedule or placebo. All patients received weekly individual cognitive-behavioral psychotherapy that primarily targeted marijuana use. Settings The trial was conducted at two university research centers in the United States. Participants One hundred and three cannabis dependent adults participated in the trial. Measurements The primary outcome measures were 1) abstinence from marijuana defined as at least two consecutive urine-confirmed abstinent weeks and 2) improvement in depressive symptoms based on the Hamilton Depression Rating Scale. Findings The proportion of patients achieving a clinically significant mood improvement [50% decrease in Hamilton Depression score from baseline] was high and did not differ between groups receiving VEN-XR (63%) and placebo (69%) (X12=0.48, p-value= 0.49). The proportion of patients achieving abstinence was low overall, but was significantly worse on VEN-XR (11.8%) compared to placebo (36.5%) (X12=7.46, p-value<0.01; OR = 4.51, 95% CI: 1.53, 13.3). Mood improvement was associated with reduction in marijuana use in the placebo group (F1,179=30.49, p-value<0.01), but not the VEN-XR group (F1,186=0.02, p-value=0.89). Conclusions For depressed, cannabis-dependent patients, venlafaxine-extended release does not appear to be effective at reducing depression and may lead to an increase in cannabis use. PMID:23297841
Brendryen, Håvar; Drozd, Filip; Kraft, Pål
2008-11-28
Happy Ending (HE) is an intense 1-year smoking cessation program delivered via the Internet and cell phone. HE consists of more than 400 contacts by email, Web pages, interactive voice response, and short message service technology. HE includes a craving helpline and a relapse prevention system, providing just-in-time therapy. All the components of the program are fully automated. The objectives were to describe the rationale for the design of HE, to assess the 12-month efficacy of HE in a sample of smokers willing to attempt to quit without the use of nicotine replacement therapy, and to explore the potential effect of HE on coping planning and self-efficacy (prior to quitting) and whether coping planning and self-efficacy mediate treatment effect. A two-arm randomized controlled trial was used. Subjects were recruited via Internet advertisements and randomly assigned to condition. Inclusion criteria were willingness to quit on a prescribed day without using nicotine replacement and being aged 18 years or older. The intervention group received HE, and the control group received a 44-page self-help booklet. Abstinence was defined as "not even a puff of smoke, for the last seven days" and was assessed by means of Internet surveys or telephone interviews 1, 3, 6, and 12 months postcessation. The main outcome was repeated point abstinence (ie, abstinence at all four time points). Coping planning and self-efficacy were measured at baseline and at the end of the preparation phase (ie, after 2 weeks of treatment, but prior to cessation day). A total of 290 participants received either the HE intervention (n=144) or the control booklet (n=146). Using intent-to-treat analysis, participants in the intervention group reported clinically and statistically significantly higher repeated point abstinence rates than control participants (20% versus 7%, odds ratio [OR] = 3.43, 95% CI = 1.60-7.34, P = .002). Although no differences were observed at baseline, by the end of the
Kim, Sunny Jung; Marsch, Lisa A; Guarino, Honoria; Acosta, Michelle C; Aponte-Melendez, Yesenia
2015-12-01
Although empirical evidence for the effectiveness of technology-mediated interventions for substance use disorders is rapidly growing, the role of baseline characteristics of patients in predicting treatment outcomes of a technology-based therapy is largely unknown. Participants were randomly assigned to either standard methadone maintenance treatment or reduced standard treatment combined with the computer-based therapeutic education system (TES). An array of demographic and behavioral characteristics of participants (N=160) was measured at baseline. Opioid abstinence and treatment retention were measured weekly for a 52-week intervention period. Generalized linear model and Cox-regression were used to estimate the predictive roles of baseline characteristics in predicting treatment outcomes. We found significant predictors of opioid abstinence and treatment retention within and across conditions. Among 21 baseline characteristics of participants, employment status, anxiety, and ambivalent attitudes toward substance use predicted better opioid abstinence in the reduced-standard-plus-TES condition compared to standard treatment. Participants who had used cocaine/crack in the past 30 days at baseline showed lower dropout rates in standard treatment, whereas those who had not used exhibited lower dropout rates in the reduced-standard-plus-TES condition. This study is the first randomized controlled trial, evaluating over a 12-month period, how various aspects of participant characteristics impact outcomes for treatments that do or do not include technology-based therapy. Compared to standard alone treatment, including TES as part of the care was preferable for patients who were employed, highly anxious, and ambivalent about substance use and did not produce worse outcomes for any subgroups of participants. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Johnson, B A; Roache, J D; Javors, M A; DiClemente, C C; Cloninger, C R; Prihoda, T J; Bordnick, P S; Ait-Daoud, N; Hensler, J
Early-onset alcoholism differs from late-onset alcoholism by its association with greater serotonergic abnormality and antisocial behaviors. Thus, individuals with early-onset alcoholism may be responsive to treatment with a selective serotonergic agent. To test the hypothesis that drinking outcomes associated with early vs late-onset alcoholism are differentially improved by the selective 5-HT(3) (serotonin) antagonist ondansetron. Double-blind, randomized, placebo-controlled clinical trial. University of Texas Health Science Center in Houston (April 1995-June 1998) and University of Texas Health Science Center in San Antonio (July 1998-December 1999). A total of 321 patients with diagnosed alcoholism (mean age, 40.6 years; 70.5% male; 78.6% white) were enrolled, 271 of whom proceeded to randomization. After 1 lead-in week of single-blind placebo, patients were randomly assigned to receive 11 weeks of treatment with ondansetron, 1 microg/kg (n = 67), 4 microg/kg (n = 77), or 16 microg/kg (n = 71) twice per day; or identical placebo (n = 56). All patients also participated in weekly standardized group cognitive behavioral therapy. Self-reported alcohol consumption (drinks per day, drinks per drinking day, percentage of days abstinent, and total days abstinent per study week); and plasma carbohydrate deficient transferrin (CDT) level, an objective and sensitive marker of transient alcohol consumption. Patients with early-onset alcoholism who received ondansetron (1, 4, and 16 microg/kg twice per day) compared with those who were administered placebo, had fewer drinks per day (1.89, 1.56, and 1.87 vs 3.30; P =.03, P =.01, and P =.02, respectively) and drinks per drinking day (4.75, 4.28, and 5.18 vs 6.90; P =.03, P =.004, and P =.03, respectively). Ondansetron, 4 microg/kg twice per day, was superior to placebo in increasing percentage of days abstinent (70.10 vs 50.20; P =.02) and total days abstinent per study week (6.74 vs 5.92; P =.03). Among patients with early
Winter, Torsten; Karvonen, Sakari; Rose, Richard J.
2016-01-01
We analyzed prevalence and stability of attitudes endorsing sexual abstinence ideals from late adolescence into early adulthood and studied associations of these attitudes with religiosity and alcohol abstinence in a sexually liberal Nordic society. Our population-based sample of Finnish twins permitted comparisons of co-twins concordant for religiosity but discordant for drinking to evaluate the association of sexual abstinence ideals with alcohol abstinence, controlling for household environment. From age 17 to 24, endorsement of sexual abstinence as a romantic ideal declined from 25% to 15%. Religiosity and alcohol abstinence correlated, both separately and together, with endorsing sexual abstinence. Abstinence ideals were associated with literal belief in fundamental tenets of the Bible. The association of sexual abstinence ideals with alcohol abstinence was confirmed in within-family comparisons of co-twins discordant for drinking but concordant for religiosity. Alcohol-abstinent twins were significantly more likely than their non-alcohol-abstinent twin siblings to endorse sexual abstinence ideals; that result suggests the association of sexual abstinence ideals with abstaining from alcohol is not explained by unmeasured confounds in familial background and structure. Our longitudinal results and analyses of discordant twins suggest that attitudes toward sexual abstinence ideals are embedded within other conservative attitudes and behaviors. PMID:23301620
Toll, Benjamin A.; O’Malley, Stephanie S.; Katulak, Nicole A.; Wu, Ran; Dubin, Joel A.; Latimer, Amy; Meandzija, Boris; George, Tony P.; Jatlow, Peter; Cooney, Judith L.; Salovey, Peter
2008-01-01
Prospect theory suggests that because smoking cessation is a prevention behavior with a fairly certain outcome, gain-framed messages will be more persuasive than loss-framed messages when attempting to encourage smoking cessation. To test this hypothesis, the authors randomly assigned participants (N = 258) in a clinical trial to either a gain- or loss-framed condition, in which they received factually equivalent video and printed messages encouraging smoking cessation that emphasized either the benefits of quitting (gains) or the costs of continuing to smoke (losses), respectively. All participants received open label sustained-release bupropion (300 mg/day) for 7 weeks. In the intent-to-treat analysis, the difference between the experimental groups by either point prevalence or continuous abstinence was not statistically significant. Among 170 treatment completers, however, a significantly higher proportion of participants were continuously abstinent in the gain-framed condition as compared with the loss-framed condition. These data suggest that gain-framed messages may be more persuasive than loss-framed messages in promoting early success in smoking cessation for participants who are engaged in treatment. PMID:18072836
Addressing Heavy Drinking in Smoking Cessation Treatment: A Randomized Clinical Trial
ERIC Educational Resources Information Center
Kahler, Christopher W.; Metrik, Jane; LaChance, Heather R.; Ramsey, Susan E.; Abrams, David B.; Monti, Peter M.; Brown, Richard A.
2008-01-01
Heavy alcohol use frequently co-occurs with cigarette smoking and may impede smoking cessation. This clinical trial examined whether smoking cessation treatment that incorporates brief alcohol intervention can improve smoking cessation outcomes (7-day verified point prevalence abstinence) and reduce drinks consumed per week. Heavy drinkers seeking…
Nollen, Nicole L; Cox, Lisa Sanderson; Mayo, Matthew S; Ellerbeck, Edward F; Madhusudhana, Sheshadri; Ahluwalia, Jasjit S
2018-05-19
Non-daily smokers (NDS) who smoke on some but not all days are a growing subset of United States (US) tobacco users. Racial/ethnic minorities are more likely to be NDS. African American NDS have strikingly high levels of nicotine and carcinogen exposure, making treatment of this high risk group a priority. The current study is one of three ongoing federally-funded clinical trials of NDS and, to our knowledge the only RCT focused on racial/ethnic minority NDS. The design has been guided by input from Patient and Stakeholder Advisory Panels who helped develop the research questions, design the intervention, and select the outcomes. The objective is to compare the effectiveness of smoking cessation counseling alone (C) or smoking cessation counseling plus participant's choice of nicotine replacement therapy (NRT; C + NRT) for African American NDS. Two-hundred seventy-eight African American NDS will be randomized in a 2:1 fashion to C + NRT or C. All participants receive five sessions of smoking cessation counseling; those randomized to C + NRT receive their choice of nicotine gum, patch, and/or lozenge. Treatment in both groups lasts for 12 weeks. We hypothesize that C + NRT will be more effective than C on the primary outcome of biochemically-confirmed abstinence from smoking at week 12. Secondary aims will compare C + NRT and C on patient- and provider-desired outcomes including abstinence from smoking at week 26, change in biochemically-verified nicotine and carcinogen exposure, days abstinent, and treatment process measures (e.g., NRT use and side effects). Predictors of abstinence will also be explored. Findings will illuminate effective treatment options for African American NDS and contribute to development of evidence-based guidelines for treating the 8.9 million US adult NDS for whom no guidelines currently exist. ClinicalTrials.gov: NCT02244918. Copyright © 2017. Published by Elsevier Inc.
The Role of BMI Change on Smoking Abstinence in a Sample of HIV-Infected Smokers
Gritz, Ellen R.; Kypriotakis, George; Arduino, Roberto C.; Vidrine, Damon J.
2016-01-01
The prevalence of cigarette smoking among persons living with HIV/AIDS (PLWHA) is approximately 40%, significantly higher than that of the general population. Identifying predictors of successful smoking cessation for PLWHA is necessary to alleviate the morbidity and mortality associated with smoking in this population. Weight gain has been associated with smoking relapse in the general population, but has not been studied among PLWHA. Data from 474 PLWHA enrolled in a smoking cessation randomized clinical trial were analyzed to examine the effect of BMI change, from baseline to 3-month follow-up, on smoking outcomes using multiple logistic regression. The odds of 7-day smoking abstinence at 3-month follow-up were 4.22 (95% CI=1.65, 10.82) times higher for participants classified as BMI decrease and 4.22 (95% CI=1.62, 11.01) times higher for participants classified as BMI increase as compared to participants with a minimal increase or decrease in BMI. In this sample, both weight gain and loss following smoking cessation were significantly associated with abstinence at 3-month follow-up among HIV-infected smokers. Further research and a better understanding of predictors of abstinence will encourage more tailored interventions, with the potential to reduce morbidity and mortality. PMID:26666313
Ussher, Michael; Aveyard, Paul; Manyonda, Isaac; Lewis, Sarah; West, Robert; Lewis, Beth; Marcus, Bess; Taylor, Adrian H; Barton, Pelham; Coleman, Tim
2012-10-04
Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA) interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP) trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date. The LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy), and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation) or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations). The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome. This trial will assess whether a PA intervention is effective when used for smoking cessation during pregnancy. ISRCTN48600346.
Randomized Trial of Four Financial-Incentive Programs for Smoking Cessation
Halpern, Scott D.; French, Benjamin; Small, Dylan S.; Saulsgiver, Kathryn; Harhay, Michael O.; Audrain-McGovern, Janet; Loewenstein, George; Brennan, Troyen A.; Asch, David A.; Volpp, Kevin G.
2015-01-01
BACKGROUND Financial incentives promote many health behaviors, but effective ways to deliver health incentives remain uncertain. METHODS We randomly assigned CVS Caremark employees and their relatives and friends to one of four incentive programs or to usual care for smoking cessation. Two of the incentive programs targeted individuals, and two targeted groups of six participants. One of the individual-oriented programs and one of the group-oriented programs entailed rewards of approximately $800 for smoking cessation; the others entailed refundable deposits of $150 plus $650 in reward payments for successful participants. Usual care included informational resources and free smoking-cessation aids. RESULTS Overall, 2538 participants were enrolled. Of those assigned to reward-based programs, 90.0% accepted the assignment, as compared with 13.7% of those assigned to deposit-based programs (P<0.001). In intention-to-treat analyses, rates of sustained abstinence from smoking through 6 months were higher with each of the four incentive programs (range, 9.4 to 16.0%) than with usual care (6.0%) (P<0.05 for all comparisons); the superiority of reward-based programs was sustained through 12 months. Group-oriented and individual-oriented programs were associated with similar 6-month abstinence rates (13.7% and 12.1%, respectively; P = 0.29). Reward-based programs were associated with higher abstinence rates than deposit-based programs (15.7% vs. 10.2%, P<0.001). However, in instrumental-variable analyses that accounted for differential acceptance, the rate of abstinence at 6 months was 13.2 percentage points (95% confidence interval, 3.1 to 22.8) higher in the deposit-based programs than in the reward-based programs among the estimated 13.7% of the participants who would accept participation in either type of program. CONCLUSIONS Reward-based programs were much more commonly accepted than deposit-based programs, leading to higher rates of sustained abstinence from smoking
Quitline Tobacco Interventions in Hospitalized Patients: A Randomized Trial.
Warner, David O; Nolan, Margaret B; Kadimpati, Sandeep; Burke, Michael V; Hanson, Andrew C; Schroeder, Darrell R
2016-10-01
Hospitalization provides an opportunity for smokers to quit, but tobacco interventions can require specialized services that are not available to many hospitals. This study tests the hypothesis that a brief intervention to facilitate the use of telephone quitline services for both initial and follow-up counseling is effective in helping patients achieve sustained abstinence. This was a population-based RCT. Participants were Olmsted County, MN residents who reported current smoking and were admitted to Mayo Clinic hospitals in Rochester, MN between May 2012 and August 2014. A control group received brief (~5-minute) cessation advice; an intervention group received a brief (~5-minute) quitline facilitation intervention, with either warm handoff or faxed referral to a national quitline provider. All were offered a 2-week supply of nicotine patches at discharge. Outcomes included self-reported 7-day point prevalence abstinence at 6 months after hospitalization and quitline utilization. Data analysis was performed from September 2014 to March 2015. Of the 1,409 eligible patients who were approached, 600 (47%) were randomized. The quitline intake call was completed by 195 subjects (65% of the intervention group). Of these, 128 (66%) completed the first coaching call. Self-reported abstinence rates at 6 months after discharge were identical in both groups (24%). The quitline facilitation intervention did not improve self-reported abstinence rates compared with a standard brief stop-smoking intervention. These results do not support the effectiveness of quitlines in providing tobacco use interventions to a general population of hospitalized smokers. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.
Strecher, Victor J; Shiffman, Saul; West, Robert
2005-05-01
To assess the efficacy of World Wide Web-based tailored behavioral smoking cessation materials among nicotine patch users. Two-group randomized controlled trial. World Wide Web in England and Republic of Ireland. A total of 3971 subjects who purchased a particular brand of nicotine patch and logged-on to use a free web-based behavioral support program. Web-based tailored behavioral smoking cessation materials or web-based non-tailored materials. Twenty-eight-day continuous abstinence rates were assessed by internet-based survey at 6-week follow-up and 10-week continuous rates at 12-week follow-up. Using three approaches to the analyses of 6- and 12-week outcomes, participants in the tailored condition reported clinically and statistically significantly higher continuous abstinence rates than participants in the non-tailored condition. In our primary analyses using as a denominator all subjects who logged-on to the treatment site at least once, continuous abstinence rates at 6 weeks were 29.0% in the tailored condition versus 23.9% in the non-tailored condition (OR = 1.30; P = 0.0006); at 12 weeks continuous abstinence rates were 22.8% versus 18.1%, respectively (OR = 1.34; P = 0.0006). Moreover, satisfaction with the program was significantly higher in the tailored than in the non-tailored condition. The results of this study demonstrate a benefit of the web-based tailored behavioral support materials used in conjunction with nicotine replacement therapy. A web-based program that collects relevant information from users and tailors the intervention to their specific needs had significant advantages over a web-based non-tailored cessation program.
Dogar, Omara; Barua, Deepa; Boeckmann, Melanie; Elsey, Helen; Fatima, Razia; Gabe, Rhian; Huque, Rumana; Keding, Ada; Khan, Amina; Kotz, Daniel; Kralikova, Eva; Newell, James N; Nohavova, Iveta; Parrott, Steve; Readshaw, Anne; Renwick, Lottie; Sheikh, Aziz; Siddiqi, Kamran
2018-04-20
Tuberculosis (TB) patients who quit smoking have much better disease outcomes than those who continue to smoke. Behavioural support combined with pharmacotherapy is the most effective strategy in helping people to quit, in general populations. However, there is no evidence for the effectiveness of this strategy in TB patients who smoke. We will assess the safety, effectiveness and cost-effectiveness of cytisine - a low-cost plant-derived nicotine substitute - for smoking cessation in TB patients compared with placebo, over and above brief behavioural support. Two-arm, parallel, double-blind, placebo-controlled, multi-centre (30 sites in Bangladesh and Pakistan), individually randomised trial. TB treatment centres integrated into public health care systems in Bangladesh and Pakistan. Newly diagnosed (in the last four weeks) adult pulmonary TB patients who are daily smokers (with or without dual smokeless tobacco use) and are interested in quitting (n= 2,388). The primary outcome measure is biochemically verified continuous abstinence from smoking at six months post-randomization, assessed using Russell Standard criteria. The secondary outcome measures include continuous abstinence at 12 months, lapses and relapses; clinical TB outcomes; nicotine dependency and withdrawal; and adverse events. This is the first smoking cessation trial of cytisine in low- and middle-income countries evaluating both cessation and tuberculosis (TB) outcomes. If found effective, cytisine could become the most affordable cessation intervention to help TB patients who smoke. This article is protected by copyright. All rights reserved.
Trivedi, Madhukar H; Greer, Tracy L; Rethorst, Chad D; Carmody, Thomas; Grannemann, Bruce D; Walker, Robrina; Warden, Diane; Shores-Wilson, Kathy; Stoutenberg, Mark; Oden, Neal; Silverstein, Meredith; Hodgkins, Candace; Love, Lee; Seamans, Cindy; Stotts, Angela; Causey, Trey; Szucs-Reed, Regina P; Rinaldi, Paul; Myrick, Hugh; Straus, Michele; Liu, David; Lindblad, Robert; Church, Timothy; Blair, Steven N; Nunes, Edward V
To evaluate exercise as a treatment for stimulant use disorders. The STimulant Reduction Intervention using Dosed Exercise (STRIDE) study was a randomized clinical trial conducted in 9 residential addiction treatment programs across the United States from July 2010 to February 2013. Of 497 adults referred to the study, 302 met all eligibility criteria, including DSM-IV criteria for stimulant abuse and/or dependence, and were randomized to either a dosed exercise intervention (Exercise) or a health education intervention (Health Education) control, both augmenting treatment as usual and conducted thrice weekly for 12 weeks. The primary outcome of percent stimulant abstinent days during study weeks 4 to 12 was estimated using a novel algorithm adjustment incorporating self-reported Timeline Followback (TLFB) stimulant use and urine drug screen (UDS) data. Mean percent of abstinent days based on TLFB was 90.8% (SD = 16.4%) for Exercise and 91.6% (SD = 14.7%) for Health Education participants. Percent of abstinent days using the eliminate contradiction (ELCON) algorithm was 75.6% (SD = 27.4%) for Exercise and 77.3% (SD = 25.1%) for Health Education. The primary intent-to-treat analysis, using a mixed model controlling for site and the ELCON algorithm, produced no treatment effect (P = .60). In post hoc analyses controlling for treatment adherence and baseline stimulant use, Exercise participants had a 4.8% higher abstinence rate (78.7%) compared to Health Education participants (73.9%) (P = .03, number needed to treat = 7.2). The primary analysis indicated no significant difference between exercise and health education. Adjustment for intervention adherence showed modestly but significantly higher percent of abstinent days in the exercise group, suggesting that exercise may improve outcomes for stimulant users who have better adherence to an exercise dose. ClinicalTrials.gov identifier: NCT01141608. © Copyright 2017 Physicians Postgraduate Press, Inc.
Struik, Laura Louise; Hammond, David; Guindon, G Emmanuel; Norman, Cameron D; Whittaker, Robyn; Burns, Catherine M; Grindrod, Kelly A; Brown, K Stephen
2015-01-01
Background Tobacco use remains the number one cause of preventable chronic disease and death in developed countries worldwide. In North America, smoking rates are highest among young adults. Despite that the majority of young adult smokers indicate wanting to quit, smoking rates among this age demographic have yet to decline. Helping young adults quit smoking continues to be a public health priority. Digital mobile technology presents a promising medium for reaching this population with smoking cessation interventions, especially because young adults are the heaviest users of this technology. Objective The primary aim of this trial is to determine the effectiveness of an evidence-informed mobile phone app for smoking cessation, Crush the Crave, on reducing smoking prevalence among young adult smokers. Methods A parallel randomized controlled trial (RCT) with two arms will be conducted in Canada to evaluate Crush the Crave. In total, 1354 young adult smokers (19 to 29 years old) will be randomized to receive the evidence-informed mobile phone app, Crush the Crave, or an evidence-based self-help guide known as “On the Road to Quitting” (control) for a period of 6 months. The primary outcome measure is a 30-day point prevalence of abstinence at the 6-month follow-up. Secondary outcomes include a 7-day point prevalence of abstinence, number of quit attempts, reduction in consumption of cigarettes, self-efficacy, satisfaction, app utilization metrics, and use of smoking cessation services. A cost-effectiveness analysis is included. Results This trial is currently open for recruitment. The anticipated completion date for the study is April 2016. Conclusions This randomized controlled trial will provide the evidence to move forward on decision making regarding the inclusion of technology-based mobile phone interventions as part of existing smoking cessation efforts made by health care providers. Evidence from the trial will also inform the development of future apps
Stanton, Cassandra A.; Lloyd-Richardson, Elizabeth E.; Papandonatos, George D.; de Dios, Marcel A.; Niaura, Raymond
2012-01-01
Cigarette smoking is highly prevalent among people living with HIV/AIDS and poses unique health risks. Smoking cessation programs tailored to this population have documented improved smoking outcomes with nicotine replacement therapy (NRT). The current study examined 6-month abstinence rates from a randomized clinical trial targeting 412 HIV-positive adult current smokers (51% European American, 19% African American, and 17% Hispanic American) and tested whether psychosocial variables, such as self-efficacy and decisional balance, mediated the relationship between NRT and long-term abstinence. Meeting criteria for complete mediation, 6-month smoking abstinence rates improved significantly with increases in these mediators, and the association of NRT and smoking abstinence was no longer significant once changes in self-efficacy and decisional balance were taken into account. Failure to translate gains in self-efficacy among African Americans into improved abstinence rates accounted for racial/ ethnic differences among participants. Specific psychosocial factors, such as self-efficacy, may be particularly amenable to change in cessation interventions and should be addressed with greater awareness of how cultural and social contextual factors impact treatment response among people living with HIV/AIDS. PMID:19537955
Riaz, Muhammad; Lewis, Sarah; Coleman, Tim; Aveyard, Paul; West, Robert; Naughton, Felix; Ussher, Michael
2016-09-01
To examine the ability of different common measures of cigarette dependence to predict smoking cessation during pregnancy. Secondary analysis of data from a parallel-group randomized controlled trial of physical activity for smoking cessation. The outcomes were biochemically validated smoking abstinence at 4 weeks post-quit and end-of-pregnancy. Women identified as smokers in antenatal clinics in 13 hospital trusts predominantly in southern England, who were recruited to a smoking cessation trial. Of 789 pregnant smokers recruited, 784 were included in the analysis. Using random-effect logistic regression models, we analysed the effects of baseline measures of cigarette dependence, including numbers of cigarettes smoked daily, Fagerström Test of Cigarette Dependence (FTCD) score, the two FTCD subscales of Heaviness of Smoking Index (HSI) and non-Heaviness of Smoking Index (non-HSI), expired carbon monoxide (CO) level and urges to smoke (strength and frequency) on smoking cessation. Associations were adjusted for significant socio-demographic/health behaviour predictors and trial variables, and area under the receiver operating characteristic (ROC) curve was used to determine the predictive ability of the model for each measure of dependence. All the dependence variables predicted abstinence at 4 weeks and end-of-pregnancy. At 4 weeks, the adjusted odds ratio (OR) (95% confidence interval) for a unit standard deviation increase in FTCD was 0.59 (0.47-0.74), expired CO = 0.54 (0.41-0.71), number of cigarettes smoked per day 0.65 (0.51-0.84) and frequency of urges to smoke 0.79 (0.63-0.98); at end-of-pregnancy they were: 0.60 (0.45-0.81), 0.55 (0.37-0.80), 0.70 (0.49-0.98) and 0.69 (0.51-0.94), respectively. HSI and non-HSI exhibited similar results to the full FTCD. Four common measures of dependence, including number of cigarettes smoked per day, scores for Fagerström Test of Cigarette Dependence and frequency of urges and level of expired CO, all
Factors Affecting Long-Term Abstinence from Substances Use
ERIC Educational Resources Information Center
Elsheikh, Salah Elgaily
2008-01-01
Objective: The purpose of this study is to explore the attitudes of abstainers from drug use that relate to the factors leading to long-term abstinence. Materials and Methods: Cross-sectional study was carried out in Al-Amal Hospital to examine, which attitudes of abstainers related to long-term abstinence. A random survey was conducted on 62…
Becoña, Elisardo; Martínez-Vispo, Carmela; Senra, Carmen; López-Durán, Ana; Rodríguez-Cano, Rubén; Fernández Del Río, Elena
2017-04-08
Smoking is an important risk factor for mental health-related problems. Numerous studies have supported a bi-directional association between cigarette smoking and depression. Despite the advances in understanding the comorbidity between both problems, the most effective psychological treatment that simultaneously targets smoking and depressive symptomatology remains unclear. The objective of this study is to assess the effectiveness of a cognitive-behavioral intervention for smoking cessation with components of behavioral activation for managing depressed mood. A single blind, three-arm, superiority randomized controlled trial is proposed. Participants will be smokers over 18 years old, who smoke at least 8 cigarettes per day. Participants will be randomized to one of three conditions, using a 2:2:1 allocation ratio: 1) standard cognitive-behavioral smoking cessation treatment; 2) standard cognitive-behavioral smoking cessation treatment plus behavioral activation; or 3) a three-month delayed treatment control group. The primary outcome measures will be biochemically verified point-prevalence abstinence (carbon monoxide in expired air) and significant change from baseline in depressive symptoms to the end of treatment, and at the 3-, 6-, and 12-month follow-up. This study aims to assess the efficacy of a cognitive-behavioral intervention with behavioral activation components for smoking cessation and depressive symptoms, compared to a standard cognitive-behavioral intervention to quit smoking. As the relation between depressive symptoms, even at subclinical levels, and quitting smoking difficulties is well known, we expect that such intervention will allow obtaining higher abstinence rates, lower relapse rates, and mood improvement. ClinicalTrials.gov : NCT02844595 . Retrospectively registered 19th July, 2016. The study started in January 2016, and the recruitment is ongoing.
Mooney, Marc E.; Schmitz, Joy M.; Allen, Sharon; Grabowski, John; Pentel, Paul; Oliver, Andrew; Hatsukami, Dorothy K.
2016-01-01
Combination of non-nicotine pharmacotherapies has been under-examined for cigarette smoking cessation. A randomized, double-blind, parallel-group double-dummy study evaluated two medications, bupropion (BUP) and naltrexone (NTX), in treatment-seeking cigarette smokers (N = 121) over a 7-week treatment intervention with 6-month follow-up. Smokers were randomized to either BUP (300 mg/day) + Placebo (PBO) or BUP (300 mg/day) + NTX (50 mg/day). The primary outcome was biochemically-verified (saliva cotinine, carbon monoxide) 7-day, point-prevalence abstinence. BUP+NTX was associated with significantly higher point-prevalence abstinence rates after 7-weeks of treatment (BUP+NTX, 54.1%; BUP+PBO, 33.3%), p = 0.0210, but not at 6-month follow-up (BUP+NTX, 27.9%; BUP+PBO, 15.0%), p = 0.09. Continuous abstinence rates did not differ, p = 0.0740 (BUP+NTX, 26.2%; BUP+PBO, 13.3%). Those receiving BUP+NTX reported reduced nicotine withdrawal, p = 0.0364. The BUP+NTX combination was associated with elevated rates of some side effects, but with no significant difference in retention between the groups. PMID:27213949
Piper, Megan E.; Vasilenko, Sara A.; Cook, Jessica W.; Lanza, Stephanie T.
2016-01-01
Aims To 1) identify distinct classes of smokers based on quit day withdrawal symptoms and 2) explore the relations between withdrawal classes and demographics, tobacco dependence, treatment, and smoking outcomes. Design Secondary data analysis of participants (N=1504) in a randomized double-blind placebo-controlled multi-site smoking cessation trial who provided ecological momentary assessments of withdrawal symptoms on their quit day. Participants received smoking cessation counseling and were randomized to receive placebo or one of five active pharmacotherapies. Setting Research offices in Madison and Milwaukee, Wisconsin, USA. Participants Adult smokers (N=1236; 58% female, 86% white), recruited from the community via advertisements, who abstained on their quit day. Measurements Demographics and tobacco dependence were assessed at baseline and participants carried palmtop computers to record withdrawal symptoms (craving, negative affect, difficulty concentrating, hunger, and anhedonia) on their quit day. Point-prevalence abstinence and latency to relapse were assessed at Weeks 8 and 26. Findings Latent class analysis identified four withdrawal classes (AIC=70.09): Moderate Withdrawal (64% of sample), High Craving-Anhedonia (8% of sample), Affective Withdrawal (13% of sample) and Hunger (15% of sample). The High Craving-Anhedonia class reported significantly higher dependence (p<0.01), were less likely to have received combination nicotine replacement, reported lower Week 8 abstinence rates, and relapsed sooner than those in the Moderate Withdrawal class (p<0.05). The Affective Withdrawal class reported higher levels of baseline negative affect and lifetime psychopathology (p<0.05) and relapsed more quickly than the Moderate Withdrawal class (p<0.01). Conclusions While the majority of smokers report typical levels of withdrawal symptoms on their quit day, more than one-third report extreme craving or extreme negative affective or extreme hunger responses to
Dallery, Jesse; Raiff, Bethany R.; Kim, Sunny Jung; Marsch, Lisa A.; Stitzer, Maxine; Grabinski, Michael J.
2016-01-01
Background and aims Contingency management (CM) is one of the most effective behavioral interventions to promote drug abstinence, but availability of this treatment is limited. We evaluated the efficacy and acceptability of Internet-based CM relative to an Internet-based monitoring and goal setting control group in a nationwide sample of cigarette smokers. Design Randomized controlled trial with 3- and 6-month follow ups. Setting USA. Participants Smokers (n=94) from 26 states were enrolled (mean age 36, 56% female). Intervention and comparator Participants were randomized to earn financial incentives (up to $480 over 7 weeks) based on video-verified abstinence using breath carbon monoxide (CO) output (n=48; Abstinent Contingent Group, AC), or based on submitting CO samples (n=46, Submission Contingent, SC). Both groups also received the same CO-based goals. A $50 deposit was required in both groups that could be recouped from initial earnings. Measures The primary outcome was point prevalence at week 4. Secondary outcomes were point prevalence at the 3- and 6-month follow-ups, percentages of negative CO samples, adherence to the CO sampling protocol, and treatment acceptability ratings on a 0–100mm visual analog scale. Findings Abstinence rates differed at 4 weeks between the AC (39.6%) and SC (13.0%) groups (odds ratio=4.4, 95% CI=1.6–12.3), but not at the 3- (29.2% AC and 19.6% SC, odds ratio=1.7, 95% CI=.6–4.4), or 6- (22.9% AC and 13.0% SC, odds ratio=2.0, 95% CI=.7–5.9) month follow-ups. During the two main treatment phases, there were significant differences in negative COs (53.9% AC and 24.8% SC, odds ratio = 3.5, 95% CI=3.1–4.0; 43.4% AC and 24.6% SC, odds ratio = 2.3, 95% CI=1.6–3.4). Adherence to the CO submission protocol was equivalent (78% AC and 85% SC, difference = 7.0%, 95% CI = −10.3%–23.8%, x2=.75, p = .39). The lowest acceptability ratings were for the items assessing the deposit, whereas the highest ratings concerned the ease of
Baskerville, Neill Bruce; Struik, Laura Louise; Hammond, David; Guindon, G Emmanuel; Norman, Cameron D; Whittaker, Robyn; Burns, Catherine M; Grindrod, Kelly A; Brown, K Stephen
2015-01-19
Tobacco use remains the number one cause of preventable chronic disease and death in developed countries worldwide. In North America, smoking rates are highest among young adults. Despite that the majority of young adult smokers indicate wanting to quit, smoking rates among this age demographic have yet to decline. Helping young adults quit smoking continues to be a public health priority. Digital mobile technology presents a promising medium for reaching this population with smoking cessation interventions, especially because young adults are the heaviest users of this technology. The primary aim of this trial is to determine the effectiveness of an evidence-informed mobile phone app for smoking cessation, Crush the Crave, on reducing smoking prevalence among young adult smokers. A parallel randomized controlled trial (RCT) with two arms will be conducted in Canada to evaluate Crush the Crave. In total, 1354 young adult smokers (19 to 29 years old) will be randomized to receive the evidence-informed mobile phone app, Crush the Crave, or an evidence-based self-help guide known as "On the Road to Quitting" (control) for a period of 6 months. The primary outcome measure is a 30-day point prevalence of abstinence at the 6-month follow-up. Secondary outcomes include a 7-day point prevalence of abstinence, number of quit attempts, reduction in consumption of cigarettes, self-efficacy, satisfaction, app utilization metrics, and use of smoking cessation services. A cost-effectiveness analysis is included. This trial is currently open for recruitment. The anticipated completion date for the study is April 2016. This randomized controlled trial will provide the evidence to move forward on decision making regarding the inclusion of technology-based mobile phone interventions as part of existing smoking cessation efforts made by health care providers. Evidence from the trial will also inform the development of future apps, provide a deeper understanding of the factors that
ERIC Educational Resources Information Center
Wong, Mee Lian; Ng, Junice Y. S.; Chan, Roy K. W.; Chio, Martin T. W.; Lim, Raymond B. T.; Koh, David
2017-01-01
We assessed the efficacy of an individual-based behavioral intervention on sexually transmitted infections' (STI) risk-reduction behaviors in Singapore. A randomized controlled trial of a behavioral intervention compared to usual care was conducted on sexually active heterosexual adolescents aged 16-19 years attending the only public STI clinic.…
Hicks, Terrell A; Thomas, Shaun P; Wilson, Sarah M; Calhoun, Patrick S; Kuhn, Eric R; Beckham, Jean C
2017-01-01
Smokers with posttraumatic stress disorder (PTSD) have increased difficulty achieving and maintaining abstinence. Contingency management approaches to smoking cessation interventions have demonstrated short-term efficacy but are limited by high rates of relapse. The goal of this pilot study was to evaluate the usability and feasibility of a smartphone-based smoking cessation application (Stay Quit Coach) designed to prevent relapse among individuals with PTSD. Smokers (N = 11) were randomized to (1) QUIT4EVER, an intervention combining mobile contingency management smoking cessation counseling and medications, and Stay Quit Coach or (2) a contact control condition that was identical to QUIT4EVER except Stay Quit Coach was not included. The primary outcome was prolonged smoking abstinence. Among those queried during the follow-up periods, average Stay Quit Coach helpfulness ratings were high and ranged from 7.25 to 10 on a 10-point Likert scale (with higher scores corresponding to greater helpfulness). The Stay Quit Coach was rated by participants as being most effective at helping to quit smoking, helping to remain quit, and providing support and relevant information about quitting. Among the three quitters in the QUIT4EVER group, all reported abstinence at 3 and 6 months; however, abstinence was only bioverified for one quitter at 6 months. Among the four quitters in the contact control condition group, three reported abstinence at 3 and 6 months, but abstinence was not confirmed by bioverification. Smokers with PTSD express interest in and helpfulness of Stay Quit Coach for remaining abstinent after a quit attempt. Combined use of mobile contingency management and Stay Quit Coach is a feasible and acceptable adjunctive smoking cessation treatment for reducing smoking among smokers with PTSD. Adequately powered clinical trials are needed to demonstrate the long-term efficacy of this combined approach to smoking cessation. This study [Use of Technological
Leggio, L.; Ferrulli, A.; Zambon, A.; Caputo, F.; Kenna, G.A.; Swift, R.M.; Addolorato, G.
2016-01-01
Hepatitis C virus (HCV) and alcoholic liver disease (ALD), either alone or in combination, count for more than two thirds of all liver diseases in the Western world. There is no safe level of drinking in HCV-infected patients and the most effective goal for these patients is total abstinence. Baclofen, a GABAB receptor agonist, represents a promising pharmacotherapy for alcohol dependence (AD). Previously, we performed a randomized clinical trial (RCT), which demonstrated the safety and efficacy of baclofen in patients affected by AD and cirrhosis. The goal of this post-hoc analysis was to explore baclofen's effect in a subgroup of alcohol-dependent HCV-infected cirrhotic patients. Any patient with HCV infection was selected for this analysis. Among the 84 subjects randomized in the main trial, 24 alcohol-dependent cirrhotic patients had a HCV infection; 12 received baclofen 10mg t.i.d. and 12 received placebo for 12-weeks. With respect to the placebo group (3/12, 25.0%), a significantly higher number of patients who achieved and maintained total alcohol abstinence was found in the baclofen group (10/12, 83.3%; p=0.0123). Furthermore, in the baclofen group, compared to placebo, there was a significantly higher increase in albumin values from baseline (p=0.0132) and a trend toward a significant reduction in INR levels from baseline (p=0.0716). In conclusion, baclofen was safe and significantly more effective than placebo in promoting alcohol abstinence, and improving some LFTs (i.e. albumin, INR) in alcohol-dependent HCV-infected cirrhotic patients. Baclofen may represent a clinically relevant alcohol pharmacotherapy for these patients. PMID:22244707
2012-01-01
Background Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA) interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP) trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date. Methods/design The LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy), and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation) or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations). The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome. Discussion This trial will assess whether a PA intervention is effective when used for smoking cessation during
Schuck, Kathrin; Bricker, Jonathan B; Otten, Roy; Kleinjan, Marloes; Brandon, Thomas H; Engels, Rutger C M E
2014-05-01
To test the effectiveness of tailored quitline (telephone) counselling among smoking parents recruited into cessation support through their children's primary schools. Two-arm randomized controlled trial with 3- and 12-month follow-up. Proactive telephone counselling was administered by the Dutch national quitline. Smoking parents were recruited through their children's primary schools and received either intensive quitline support in combination with tailored supplementary materials (n = 256) or a standard self-help brochure (n = 256). The primary outcome was 7-day point-prevalence abstinence at 12-month follow-up. Also measured were baseline characteristics, use of and adherence to nicotine replacement therapy and pharmacotherapy, smoking characteristics and implementation of a home smoking ban. Parents who received quitline counselling were more likely to report 7-day point-prevalence abstinence at 12-month assessment [34.0 versus 18.0%, odds ratio (OR) = 2.35, confidence interval (CI) = 1.56-3.54] than those who received a standard self-help brochure. Parents who received quitline counselling were more likely to use nicotine replacement therapy (P < 0.001) than those who received a standard self-help brochure. Among parents who did not achieve abstinence, those who received quitline counselling smoked fewer cigarettes at 3-month (P < 0.001) and 12-month assessment (P < 0.001), were more likely to make a quit attempt (P < 0.001), to achieve 24 hours' abstinence (P < 0.001) and to implement a complete home smoking ban (P < 0.01). Intensive quitline support tailored to smoking parents is an effective method for helping parents quit smoking and promoting parenting practices that protect their children from adverse effects of smoking. © 2014 Society for the Study of Addiction.
Kahler, Christopher W; Surace, Anthony; Rebecca, E F; Gordon, B A; Cioe, Patricia A; Spillane, Nichea S; Parks, Acacia; Bock, Beth C; Brown, Richard A
2018-06-21
Despite reductions in cigarette smoking in the U.S., improvements in the efficacy of smoking cessation treatments are needed, as rates of sustained abstinence remain disappointingly low. Both low positive affect and high negative affect contribute to smoking relapse and constitute viable targets for smoking cessation interventions. Although some clinical trials have evaluated interventions to address depression as a smoking relapse risk factor, very few have focused on positive affect. Recently, we developed and conducted a preliminary clinical trial of a smoking cessation treatment that targets positive affect and cognitions by incorporating interventions rooted in positive psychology. The current randomized controlled trial will expand upon this preliminary trial to test whether this positive psychology-informed approach results in higher smoking cessation rates compared to a time-matched standard smoking cessation treatment control. Three hundred and forty adult daily smokers will be randomly assigned to either positive psychotherapy for smoking cessation or standard behavioral smoking cessation counseling. Participants will meet weekly with a study counselor for 6 weeks and will receive transdermal nicotine patch and text messaging smoking cessation support. Additionally, text messaging in the positive psychotherapy condition will encourage engagement in positive psychology-specific strategies for boosting mood and staying smoke free. Smoking cessation outcomes will be measured at 12, 26, and 52 weeks following target quit date. Results from this study will provide evidence on whether incorporating positive psychology interventions into smoking cessation treatment can improve smoking cessation outcomes relative to standard behavioral counseling with nicotine patch and text messaging. Copyright © 2018. Published by Elsevier Inc.
Mackillop, James; Murphy, Cara M.; Martin, Rosemarie A.; Stojek, Monika; Tidey, Jennifer W.; Colby, Suzanne M.
2016-01-01
Abstract Introduction: A cigarette purchase task (CPT) is a behavioral economic measure of the reinforcing value of smoking in monetary terms (ie, cigarette demand). This study investigated whether cigarette demand predicted response to contingent monetary rewards for abstinence among individuals with substance use disorders. It also sought to replicate evidence for greater price sensitivity at whole-dollar pack price transitions (ie, left-digit effects). Methods: Participants ( N = 338) were individuals in residential substance use disorder treatment who participated in a randomized controlled trial that compared contingent vouchers to noncontingent vouchers for smoking abstinence. Baseline demand indices were used to predict number of abstinent days during the 14-day voucher period (after the reduction lead-in) and at 1 and 3 months afterward. Results: Demand indices correlated with measures of smoking and nicotine dependence. As measured by elasticity, intensity and Omax , higher demand significantly predicted fewer abstinent exhaled carbon monoxide readings during voucher period for individuals in the noncontingent vouchers condition. Breakpoint exhibited a trend-level association with abstinent exhaled carbon monoxide readings. Demand indices did not predict abstinence in the contingent vouchers group, and did not predict abstinence at 1- and 3-month follow-ups. Left-digit price transitions were associated with significantly greater reductions in consumption. Conclusions: The association of cigarette demand with smoking behavior only in the group for whom abstinence was not incentivized indicates that CPT assesses the value of smoking more than the value of money per se and that vouchers counteract the effects of the intrinsic reinforcing value of cigarettes. Results provide initial short-term evidence of predictive validity for the CPT indices. Implications: This study provides the first evidence of the validity of the CPT for predicting early response to
Abstinence and abstinence-only education.
Ott, Mary A; Santelli, John S
2007-10-01
To review recent literature on medical accuracy, program effectiveness, and ethical concerns related to abstinence-only policies for adolescent sexuality education. The federal government invests over 175 million dollars annually in 'abstinence-only-until-marriage' programs. These programs are required to withhold information on contraception and condom use, except for information on failure rates. Abstinence-only curricula have been found to contain scientifically inaccurate information, distorting data on topics such as condom efficacy, and promote gender stereotypes. An independent evaluation of the federal program, several systematic reviews, and cohort data from population-based surveys find little evidence of efficacy and evidence of possible harm. In contrast, comprehensive sexuality education programs have been found to help teens delay initiation of intercourse and reduce sexual risk behaviors. Abstinence-only policies violate the human rights of adolescents because they withhold potentially life-saving information on HIV and other sexually transmitted infections. Federal support of abstinence-only as an approach to adolescent sexuality education is of much concern due to medical inaccuracies, lack of effectiveness, and the withholding and distorting of health information.
Khan, Anam; Tansel, Aylin; White, Donna L; Kayani, Waleed Tallat; Bano, Shah; Lindsay, Jan; El-Serag, Hashem B; Kanwal, Fasiha
2016-02-01
We conducted a systematic review of efficacy of psychosocial interventions in inducing or maintaining alcohol abstinence in patients with chronic liver disease (CLD) and alcohol use disorder (AUD). We performed structured keyword searches in PubMed, PsychINFO, and MEDLINE for original research articles that were published from January 1983 through November 2014 that evaluated the use of psychosocial interventions to induce or maintain alcohol abstinence in patients with CLD and AUD. We identified 13 eligible studies that comprised 1945 patients; 5 were randomized controlled trials (RCTs). Delivered therapies included motivational enhancement therapy, cognitive behavioral therapy (CBT), motivational interviewing, supportive therapy, and psychoeducation either alone or in combination in the intervention group and general health education or treatment as usual in the control group. All studies of induction of abstinence (4 RCTs and 6 observational studies) reported an increase in abstinence among participants in the intervention and control groups. Only an integrated therapy that combined CBT and motivational enhancement therapy with comprehensive medical care, delivered during a period of 2 years, produced a significant increase in abstinence (74% increase in intervention group vs 48% increase in control group, P = .02), which was reported in 1 RCT. All studies of maintenance of abstinence (1 RCT and 2 observational studies) observed recidivism in the intervention and control groups. Only an integrated therapy that combined medical care with CBT produced a significantly smaller rate of recidivism (32.7% in integrated CBT group vs 75% in control group, P = .03), which was reported from 1 observational study. However, data were not collected for more than 2 years on outcomes of patients with CLD and AUD. In a systematic analysis of studies of interventions to induce or maintain alcohol abstinence in patients with CLD and AUD, integrated combination psychotherapy with
Khan, Anam; Tansel, Aylin; White, Donna L.; Kayani, Waleed Tallat; Bano, Shah; Lindsay, Jan; El-Serag, Hashem B.; Kanwal, Fasiha
2016-01-01
Background & Aims We conducted a systematic review of efficacy of psychosocial interventions in inducing or maintaining alcohol abstinence in patients with chronic liver disease (CLD) and alcohol use disorder (AUD). Methods We performed structured keyword searches in PubMed, PsychINFO, and MEDLINE for original research articles, published from January 1983 through November 2014, that evaluated the use of psychosocial interventions to induce or maintain alcohol abstinence in patients with CLD and AUD. Results We identified 13 eligible studies, comprising 1945 patients; 5 were randomized controlled trials (RCTs). Delivered therapies included motivational enhancement therapy (MET), cognitive behavioral therapy (CBT), motivational interviewing (MI), supportive therapy and psychoeducation either alone or in combination in the intervention group and general health education or treatment as usual in the control group. All studies of induction of abstinence (4 RCTs and 6 observational studies) reported an increase in abstinence among participants in the intervention and control groups. Only an integrated therapy that combined CBT and MET with comprehensive medical care, delivered over 2 years, produced a significant increase in abstinence (74% increase in intervention group versus 48% increase in control group; P=.02), reported in 1 RCT. All studies of maintenance of abstinence (1 RCT and 2 observational studies) observed recidivism in the intervention and control groups. Only an integrated therapy that combined medical care with CBT produced a significantly smaller rate of recidivism (32.7% in integrated CBT group versus 75% decrease in control group, P=.03), reported from 1 observational study. However, data were not collected for more than 2 y on outcomes of patients with CLD and AUD. Conclusion In a systematic analysis of studies of interventions to induce or maintain alcohol abstinence in patients with CLD and AUD, integrated combination psychotherapy with CBT
Levin, Frances R.; Mariani, John J.; Brooks, Daniel J.; Pavlicova, Martina; Cheng, Wendy; Nunes, Edward
2011-01-01
Cannabis dependence is a substantial public health problem. Behavioral treatments have shown promise, but there are no effective medications for cannabis dependence. The purpose of this study was to evaluate the safety and efficacy of dronabinol, a synthetic form of delta-9-tetrahydrocannabinol, a naturally occurring pharmacologically active component of marijuana, in treating cannabis dependence. 156 cannabis-dependent adults were enrolled in a randomized, double-blind, placebo-controlled, 12-week trial. After a 1-week placebo lead-in phase, participants were randomized to receive dronabinol 20 mg twice a day or placebo. Doses were maintained until the end of week 8 and then tapered off over 2 weeks. All participants received weekly motivational enhancement and relapse prevention therapy. Marijuana use was assessed using the timeline followback method. There was no significant difference between treatment groups in the proportion of participants who achieved 2 weeks of abstinence at the end of the maintenance phase (dronabinol: 17.7%; placebo: 15.6%). Although both groups showed a reduction in marijuana use over time, there were no differences between the groups. Treatment retention was significantly higher at the end of the maintenance phase on dronabinol (77%), compared to placebo (61%) (P = .02), and withdrawal symptoms were significantly lower on dronabinol than placebo (P= .02). This is the first trial using an agonist substitution strategy for treatment of cannabis dependence. Dronabinol showed promise, it was well-tolerated, and improved treatment retention and withdrawal symptoms. Future trials might test higher doses, combinations of dronabinol with other medications with complementary mechanisms, or with more potent behavioral interventions. PMID:21310551
A double-blind randomized controlled trial of N-acetylcysteine in cannabis-dependent adolescents
Gray, Kevin M.; Carpenter, Matthew J.; Baker, Nathaniel L.; DeSantis, Stacia M.; Kryway, Elisabeth; Hartwell, Karen J.; McRae-Clark, Aimee L.; Brady, Kathleen T.
2012-01-01
Objective Preclinical findings suggest that the over-the-counter supplement N-acetylcysteine, via glutamate modulation in the nucleus accumbens, holds promise as a pharmacotherapy targeting substance dependence. We sought to investigate N-acetylcysteine as a novel cannabis cessation treatment in adolescents, a vulnerable group for whom existing treatments have limited efficacy. Method In this 8-week double-blind randomized placebo-controlled trial, treatment-seeking cannabis-dependent adolescents (age 15-21, N = 116) received N-acetylcysteine (1200 mg) or placebo twice daily, each added to a contingency management intervention and brief (≤10 minute) weekly cessation counseling. The primary efficacy measure was the odds of negative weekly urine cannabinoid tests during treatment among participants receiving N-acetylcysteine versus placebo, via intent-to-treat analysis. The primary tolerability measure was frequency of adverse events, compared by treatment group. Results N-acetylcysteine was well tolerated with minimal adverse events. N-acetylcysteine participants had more than twice the odds, compared to placebo participants, of submitting negative urine cannabinoid tests during treatment (odds ratio = 2.4, [95% CI: 1.1-5.2], p = 0.029). Exploratory secondary abstinence outcomes numerically favored N-acetylcysteine, but were not statistically significant. Conclusions This is the first randomized trial of pharmacotherapy for cannabis dependence in any age group yielding a positive primary cessation outcome via intent-to-treat analysis. Findings support N-acetylcysteine as a pharmacotherapy to complement psychosocial treatment for cannabis dependence in adolescents. Further research is needed to replicate these findings and explore the efficacy of N-acetylcysteine across a variety of treatment contexts and outcomes. Trial Registration clinicaltrials.gov identifier: NCT 01005810 PMID:22706327
Petry, Nancy M; Roll, John M
2011-12-01
Contingency management (CM) treatments that provide patients with the opportunity to earn chances of winning prizes of varying magnitudes are becoming increasingly popular. In the CM literature, magnitude of reinforcement is linked with effect sizes, such that CM treatments that provide larger magnitude reinforcement are more efficacious than those that provide lower magnitude reinforcement. With prize CM, even when magnitudes of overall expected prize earnings are constant, some patients win more prizes than others. Thus, patients who win larger overall amounts of prizes during treatment may have better outcomes than those who win fewer prizes. This study evaluated the impact of overall amounts of prizes won on long-term abstinence outcomes. The dollar amount of prizes won during prize CM treatments was determined from 78 cocaine-abusing methadone-maintenance patients who were randomized to prize CM treatments in three clinical trials. Abstinence three months following the end of the CM intervention was the primary dependent variable. The dollar amount of prizes won during CM treatment was a significant predictor of submission of cocaine-negative urine samples and self-reports of cocaine abstinence at the follow-up evaluation, even after controlling for other variables associated with long-term abstinence, such as pretreatment urinalysis results and longest duration of abstinence achieved during treatment. These results suggest that magnitudes of earnings during prize CM may impact outcomes and call for further experimentation of parameters related to the efficacy of prize CM.
Does Motivation Matter? Analysis of a Randomized Trial of Proactive Outreach to VA Smokers.
Danan, Elisheva R; Joseph, Anne M; Sherman, Scott E; Burgess, Diana J; Noorbaloochi, Siamak; Clothier, Barbara; Japuntich, Sandra J; Taylor, Brent C; Fu, Steven S
2016-08-01
Current guidelines advise providers to assess smokers' readiness to quit, then offer cessation therapies to smokers planning to quit and motivational interventions to smokers not planning to quit. We examined the relationship between baseline stage of change (SOC), treatment utilization, and smoking cessation to determine whether the effect of a proactive smoking cessation intervention was dependent on smokers' level of motivation to quit. Secondary analysis of a multicenter randomized controlled trial. A total of 3006 current smokers, aged 18-80 years, at four Veterans Affairs (VA) medical centers. Proactive care included proactive outreach (mailed invitation followed by telephone outreach), offer of smoking cessation services (telephone or face-to-face), and access to pharmacotherapy. Usual care participants had access to VA smoking cessation services and state telephone quitlines. Baseline SOC measured with Readiness to Quit Ladder, and 6-month prolonged abstinence self-reported at 1 year. At baseline, 35.8 % of smokers were in preparation, 38.2 % in contemplation, and 26.0 % in precontemplation. The overall interaction between SOC and treatment arm was not statistically significant (p = 0.30). Among smokers in preparation, 21.1 % of proactive care participants achieved 6-month prolonged abstinence, compared to 13.1 % of usual care participants (OR, 1.8 [95 % CI, 1.2-2.6]). Similarly, proactive care increased abstinence among smokers in contemplation (11.0 % vs. 6.5 %; OR, 1.8 [95 % CI, 1.1-2.8]). Smokers in precontemplation quit smoking at similar rates (5.3 % vs. 5.6 %; OR, 0.9 [95 % CI, 0.5-1.9]). Within each stage, uptake of smoking cessation treatments increased with higher SOC and with proactive care as compared with usual care. Mostly male participants limits generalizability. Randomization was not stratified by SOC. Proactive care increased treatment uptake compared to usual care across all SOC. Proactive care increased smoking cessation
Hajek, P; West, R; Foulds, J; Nilsson, F; Burrows, S; Meadow, A
1999-09-27
There are several nicotine replacement products on the market, and physicians are likely to be asked with increasing frequency about which of these products their patients should use. To provide a basis for rational advice by comparing nicotine polacrilex (gum), a transdermal patch, nasal spray, and an inhaler. Randomized trial with assessments at the quit date and 1, 4, and 12 weeks later. Hospital smokers' clinic. Male and female community volunteers (N = 504) smoking 10 or more cigarettes per day and seeking help to stop smoking. Patients were given brief advice, and purchased their nicotine replacement treatment at approximately half the regular retail price. Nicotine replacement treatment use, ratings of withdrawal symptoms, ratings of product characteristics and helpfulness, and biochemically validated continuous lapse-free abstinence. The products did not differ in their effects on withdrawal discomfort, urges to smoke, or rates of abstinence. The continuous validated 12-week abstinence rates were 20%, 21%, 24%, and 24% in the gum, patch, spray, and inhaler groups, respectively. Compliance with recommended nicotine replacement treatment use was high for the patch, low for gum, and very low for the spray and the inhaler. The spray was underused because of adverse effects more often than the other products. In the subjects using the spray, the level of use among abstainers at week 1 predicted outcome at week 12. The inhaler was rated as more embarrassing to use than the other products, but provided at least as much nicotine as the gum. When asked about nicotine replacement treatment products available, physicians should note that, despite low compliance with the recommended dose of the spray and inhaler and differences in product ratings, overall, there are no notable differences between the products in their effects on withdrawal discomfort, perceived helpfulness, or general efficacy.
Wilson, Sarah M.; Hair, Lauren P.; Hertzberg, Jeffrey S.; Kirby, Angela C.; Olsen, Maren K.; Lindquist, Jennifer H.; Maciejewski, Matthew L.; Beckham, Jean C.; Calhoun, Patrick S.
2016-01-01
Introduction Smoking is the most preventable cause of morbidity and mortality in U.S. veterans. Rural veterans in particular have elevated risk for smoking and smoking-related illness. However, these veterans underutilize smoking cessation treatment, which suggests that interventions for rural veterans should optimize efficacy and reach. Objective The primary goal of the current study is to evaluate the effectiveness of an intervention that combines evidenced based treatment for smoking cessation with smart-phone based, portable contingency management on smoking rates compared to a contact control intervention in a randomized controlled trial among rural Veteran smokers. Specifically, Veterans will be randomized to receive Abstinence Reinforcement Therapy (ART) which combines evidenced based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM) or a control condition (i.e., TC and NRT alone) that will provide controls for therapist, medication, time and attention effects. Methods Smokers were identified using VHA electronic medical records and recruited proactively via telephone. Participants (N = 310) are randomized to either ART or a best practice control consisting of telephone counseling and telemedicine. Participating patients will be surveyed at 3-months, 6-months and 12-months post-randomization. The primary outcome measure is self-reported and biochemically validated prolonged abstinence at 6-month follow-up. Discussion This trial is designed to test the relative effectiveness of ART compared to a telehealth-only comparison group. Dissemination of this mHealth intervention for veterans in a variety of settings would be warranted if ART improves smoking outcomes for rural veterans and is cost-effective. PMID:27521811
Trigo, Jose M; Soliman, Alexandra; Quilty, Lena C; Fischer, Benedikt; Rehm, Jürgen; Selby, Peter; Barnes, Allan J; Huestis, Marilyn A; George, Tony P; Streiner, David L; Staios, Gregory; Le Foll, Bernard
2018-01-01
The current lack of pharmacological treatments for cannabis use disorder (CUD) warrants novel approaches and further investigation of promising pharmacotherapy. We previously showed that nabiximols (27 mg/ml Δ9-tetrahydrocannabinol (THC)/ 25 mg/ml cannabidiol (CBD), Sativex®) can decrease cannabis withdrawal symptoms. Here, we assessed in a pilot study the tolerability and safety of self-titrated nabiximols vs. placebo among 40 treatment-seeking cannabis-dependent participants. Subjects participated in a double blind randomized clinical trial, with as-needed nabiximols up to 113.4 mg THC/105 mg CBD or placebo daily for 12 weeks, concurrently with Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). Primary outcome measures were tolerability and abstinence, secondary outcome measures were days and amount of cannabis use, withdrawal, and craving scores. Participants received up to CDN$ 855 in compensation for their time. Medication was well tolerated and no serious adverse events (SAEs) were observed. Rates of adverse events did not differ between treatment arms (F1,39 = 0.205, NS). There was no significant change in abstinence rates at trial end. Participants were not able to differentiate between subjective effects associated with nabiximols or placebo treatments (F1,40 = 0.585, NS). Cannabis use was reduced in the nabiximols (70.5%) and placebo groups (42.6%). Nabiximols reduced cannabis craving but no significant differences between the nabiximols and placebo groups were observed on withdrawal scores. Nabiximols in combination with MET/CBT was well tolerated and allowed for reduction of cannabis use. Future clinical trials should explore the potential of high doses of nabiximols for cannabis dependence.
Cummins, Sharon; Zhu, Shu-Hong; Gamst, Anthony; Kirby, Carrie; Brandstein, Kendra; Klonoff-Cohen, Hillary; Chaplin, Edward; Morris, Timothy; Seymann, Gregory; Lee, Joshua
2012-08-01
Hospitalized smokers often quit smoking, voluntarily or involuntarily; most relapse soon after discharge. Extended follow-up counseling can help prevent relapse. However, it is difficult for hospitals to provide follow-up and smokers rarely leave the hospital with quitting aids (for example, nicotine patches). This study aims to test a practical model in which hospitals work with a state cessation quitline. Hospital staff briefly intervene with smokers at bedside and refer them to the quitline. Depending on assigned condition, smokers may receive nicotine patches at discharge or extended quitline telephone counseling post-discharge. This project establishes a practical model that lends itself to broader dissemination, while testing the effectiveness of the interventions in a rigorous randomized trial. This randomized clinical trial (N = 1,640) tests the effect of two interventions on long-term quit rates of hospitalized smokers in a 2 x 2 factorial design. The interventions are (1) nicotine patches (eight-week, step down program) dispensed at discharge and (2) proactive telephone counseling provided by the state quitline after discharge. Subjects are randomly assigned into: usual care, nicotine patches, telephone counseling, or both patches and counseling. It is hypothesized that patches and counseling have independent effects and their combined effect is greater than either alone. The primary outcome measure is thirty-day abstinence at six months; a secondary outcome is biochemically validated smoking status. Cost-effectiveness analysis is conducted to compare each intervention condition (patch alone, counseling alone, and combined interventions) against the usual care condition. Further, this study examines whether smokers' medical diagnosis is a moderator of treatment effect. Generalized linear (binomial) mixed models will be used to study the effect of treatment on abstinence rates. Clustering is accounted for with hospital-specific random effects. If this
Randomized open-label trial of baclofen for relapse prevention in alcohol dependence.
Gupta, Manushree; Verma, Pankaj; Rastogi, Rajesh; Arora, Sheetal; Elwadhi, Deeksha
2017-05-01
Alcohol dependence is a progressive chronic disorder characterized by narrowing of the drinking repertoire, salience of drinking, tolerance and withdrawal phenomenon, compulsion to drink, and frequent relapses. Baclofen has been shown to promote abstinence, to reduce craving, and to reduce anxiety in alcohol-dependent individuals, and it promises to be a useful agent, although clinical data are limited at present. The current study aimed to test the utility of baclofen, a GABA agonist, in improving the relapse rates in alcohol-dependent subjects. A total of 122 alcohol-dependent subjects were randomized into two groups. Groups were administered baclofen (30 mg/day) or benfothiamine (a nutritional supplement) using an open label design. Both groups received brief motivational intervention. Subjects were assessed at 0, 2, 4, 8, and 12 weeks for the primary outcome measures: time to first relapse, heavy drinking days, cumulative abstinence duration, and craving (measured by the Obsessive Compulsive Drinking Scale (OCDS)). Seventy-two participants received baclofen, and 50 received benfothiamine. Participants receiving baclofen remained abstinent for significantly more days than the benfothiamine group (p < 0.05). The percentage of heavy drinking days was significantly lower in the baclofen group (p = 0.001). Craving and anxiety scores (Hamilton Anxiety Rating Scale) were also significantly decreased in the baclofen group relative to the control group (p = 0.001). Time to first relapse was similar in both groups. In this open-label trial, alcohol-dependent participants receiving baclofen showed significant improvements in drinking outcomes compared with participants receiving benfothiamine. This study provides further evidence that baclofen is useful for the treatment of alcohol dependence.
Randomized Trial of Reduced-Nicotine Standards for Cigarettes.
Donny, Eric C; Denlinger, Rachel L; Tidey, Jennifer W; Koopmeiners, Joseph S; Benowitz, Neal L; Vandrey, Ryan G; al'Absi, Mustafa; Carmella, Steven G; Cinciripini, Paul M; Dermody, Sarah S; Drobes, David J; Hecht, Stephen S; Jensen, Joni; Lane, Tonya; Le, Chap T; McClernon, F Joseph; Montoya, Ivan D; Murphy, Sharon E; Robinson, Jason D; Stitzer, Maxine L; Strasser, Andrew A; Tindle, Hilary; Hatsukami, Dorothy K
2015-10-01
The Food and Drug Administration can set standards that reduce the nicotine content of cigarettes. We conducted a double-blind, parallel, randomized clinical trial between June 2013 and July 2014 at 10 sites. Eligibility criteria included an age of 18 years or older, smoking of five or more cigarettes per day, and no current interest in quitting smoking. Participants were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes, provided free. The investigational cigarettes had nicotine content ranging from 15.8 mg per gram of tobacco (typical of commercial brands) to 0.4 mg per gram. The primary outcome was the number of cigarettes smoked per day during week 6. A total of 840 participants underwent randomization, and 780 completed the 6-week study. During week 6, the average number of cigarettes smoked per day was lower for participants randomly assigned to cigarettes containing 2.4, 1.3, or 0.4 mg of nicotine per gram of tobacco (16.5, 16.3, and 14.9 cigarettes, respectively) than for participants randomly assigned to their usual brand or to cigarettes containing 15.8 mg per gram (22.2 and 21.3 cigarettes, respectively; P<0.001). Participants assigned to cigarettes with 5.2 mg per gram smoked an average of 20.8 cigarettes per day, which did not differ significantly from the average number among those who smoked control cigarettes. Cigarettes with lower nicotine content, as compared with control cigarettes, reduced exposure to and dependence on nicotine, as well as craving during abstinence from smoking, without significantly increasing the expired carbon monoxide level or total puff volume, suggesting minimal compensation. Adverse events were generally mild and similar among groups. In this 6-week study, reduced-nicotine cigarettes versus standard-nicotine cigarettes reduced nicotine exposure and dependence and the number of cigarettes smoked. (Funded by the National Institute on Drug Abuse
ERIC Educational Resources Information Center
Subramaniam, Geetha A.; Warden, Diane; Minhajuddin, Abu; Fishman, Marc J.; Stitzer, Maxine L.; Adinoff, Bryon; Trivedi, Madhukar; Weiss, Roger; Potter, Jennifer; Poole, Sabrina A.; Woody, George E.
2011-01-01
Objective: To examine predictors of opioid abstinence in buprenorphine/naloxone (Bup/Nal)-assisted psychosocial treatment for opioid-dependent youth. Method: Secondary analyses were performed of data from 152 youth (15-21 years old) randomly assigned to 12 weeks of extended Bup/Nal therapy or up to 2 weeks of Bup/Nal detoxification with weekly…
Randomized Trial of Nicotine Lozenges and Phone Counseling for Smokeless Tobacco Cessation
Danaher, Brian G.; Ebbert, Jon O.; van Meter, Nora; Lichtenstein, Edward; Widdop, Chris; Crowley, Ryann; Akers, Laura; Seeley, John R.
2015-01-01
Introduction: Relatively few treatment programs have been developed specifically for smokeless tobacco (ST) users who want to quit. Their results suggest that self-help materials, telephone counseling, and nicotine lozenges are efficacious. This study provides the first direct examination of the separate and combined effects of telephone counseling and lozenges. Methods: We recruited ST users online (N = 1067) and randomly assigned them to 1 of 3 conditions: (a) a lozenge group (n = 356), who were mailed 4-mg nicotine lozenges; (b) a coach calls group (n = 354), who were offered 3 coaching phone calls; or (c) a lozenge + coach calls group (N = 357), who received both lozenges and coaching calls. Additionally, all participants were mailed self-help materials. Self-reported tobacco abstinence was assessed at 3 and 6 months after randomization. Results: Complete-case and intention-to-treat (ITT) analyses for all tobacco abstinence were performed at 3 months, 6 months, and both 3 and 6 months (repeated point prevalence). ITT analyses revealed a highly similar result: the lozenge + coach calls condition was significantly more successful in encouraging tobacco abstinence than either the lozenge group or the coach calls group, which did not differ. Conclusions: Combining nicotine lozenges and phone counseling significantly increased tobacco abstinence rates compared with either intervention alone, whereas coach calls and lozenges were equivalent. The study confirms the high tobacco abstinence rates for self-help ST cessation interventions and offers guidance to providing tobacco treatment to ST users. PMID:25168034
A Pragmatic Trial of E-Cigarettes, Incentives, and Drugs for Smoking Cessation.
Halpern, Scott D; Harhay, Michael O; Saulsgiver, Kathryn; Brophy, Christine; Troxel, Andrea B; Volpp, Kevin G
2018-06-14
Whether financial incentives, pharmacologic therapies, and electronic cigarettes (e-cigarettes) promote smoking cessation among unselected smokers is unknown. We randomly assigned smokers employed by 54 companies to one of four smoking-cessation interventions or to usual care. Usual care consisted of access to information regarding the benefits of smoking cessation and to a motivational text-messaging service. The four interventions consisted of usual care plus one of the following: free cessation aids (nicotine-replacement therapy or pharmacotherapy, with e-cigarettes if standard therapies failed); free e-cigarettes, without a requirement that standard therapies had been tried; free cessation aids plus $600 in rewards for sustained abstinence; or free cessation aids plus $600 in redeemable funds, deposited in a separate account for each participant, with money removed from the account if cessation milestones were not met. The primary outcome was sustained smoking abstinence for 6 months after the target quit date. Among 6131 smokers who were invited to enroll, 125 opted out and 6006 underwent randomization. Sustained abstinence rates through 6 months were 0.1% in the usual-care group, 0.5% in the free cessation aids group, 1.0% in the free e-cigarettes group, 2.0% in the rewards group, and 2.9% in the redeemable deposit group. With respect to sustained abstinence rates, redeemable deposits and rewards were superior to free cessation aids (P<0.001 and P=0.006, respectively, with significance levels adjusted for multiple comparisons). Redeemable deposits were superior to free e-cigarettes (P=0.008). Free e-cigarettes were not superior to usual care (P=0.20) or to free cessation aids (P=0.43). Among the 1191 employees (19.8%) who actively participated in the trial (the "engaged" cohort), sustained abstinence rates were four to six times as high as those among participants who did not actively engage in the trial, with similar relative effectiveness. In this pragmatic
Dallery, Jesse; Raiff, Bethany R; Kim, Sunny Jung; Marsch, Lisa A; Stitzer, Maxine; Grabinski, Michael J
2017-05-01
Contingency management (CM) is one of the most effective behavioral interventions to promote drug abstinence, but availability of this treatment is limited. We evaluated the efficacy and acceptability of internet-based CM relative to an internet-based monitoring and goal-setting control group in a nationwide sample of cigarette smokers. Randomized controlled trial with 3- and 6-month follow-ups. United States. Smokers (n = 94) from 26 states were enrolled (mean age 36, 56% female). Participants were randomized to earn financial incentives (up to $480 over 7 weeks) based on video-verified abstinence using breath carbon monoxide (CO) output (n = 48; abstinent contingent group, AC), or based on submitting CO samples (n = 46, submission contingent, SC). Both groups also received the same CO-based goals. A $50 deposit was required in both groups that could be recouped from initial earnings. The primary outcome was point prevalence at week 4. Secondary outcomes were point prevalence at the 3- and 6-month follow-ups, percentages of negative CO samples, adherence to the CO sampling protocol, and treatment acceptability ratings on a 0-100-mm visual analog scale. Abstinence rates differed at 4 weeks between the AC (39.6%) and SC (13.0%) groups [odds ratio (OR) = 4.4, 95% confidence interval (CI) = 1.6-12.3], but not at the 3- (29.2% AC and 19.6% SC, OR = 1.7, 95% CI = 0.6-4.4) or 6- (22.9% AC and 13.0% SC, OR = 2.0, 95% CI = 0.7-5.9) month follow-ups. During the two main treatment phases, there were significant differences in negative COs (53.9% AC and 24.8% SC, OR = 3.5, 95% CI = 3.1-4.0; 43.4% AC and 24.6% SC, OR = 2.3, 95% CI = 1.6-3.4). Adherence to the CO submission protocol was equivalent (78% AC and 85% SC, difference = 7.0%, 95% CI = -10.3 to 23.8 %, F < 1, P = 0.39). The lowest acceptability ratings were for the items assessing the deposit, whereas the highest ratings concerned the ease of the intervention, the graph of CO
Klemperer, Elias M; Hughes, John R; Solomon, Laura J; Callas, Peter W; Fingar, James R
2017-01-01
To test whether, in comparison to usual care, brief motivational or reduction interventions increase quit attempts (QA) or abstinence among smokers who are not ready to quit. A parallel-group randomized controlled trial of brief motivational (n = 185), reduction (n = 186) or usual care (n = 189) telephone interventions delivered over the course of 4 weeks. Outcomes were assessed at 6- and 12-month follow-ups. No medication was provided. United States. A total of 560 adult smokers of ≥ 10 cigarettes per day who were not ready to quit in the next 30 days. The primary outcomes were whether participants made a QA that lasted ≥ 24 hours and whether they made a QA of any length between baseline and 6 months. Secondary outcomes included 7-day point-prevalence abstinence at 6 and 12 months. The 12-month follow-up was added after the study began. A priori-defined comparisons were between motivational versus usual care and reduction versus usual care conditions. The probability of making a QA that lasted ≥ 24 hours was not significantly different between the motivational (38%) or the reduction (31%) conditions and the usual care (34%) condition [motivational versus usual care odds ratio (OR) = 1.19, 95% confidence interval (CI) = 0.78-1.82; reduction versus usual care OR = 0.89, 95% CI = 0.57-1.36]. Bayes factors ranged from 0.13 to 0.18. Findings regarding a QA of any length were similar. At 6 months, the motivational condition had marginally more abstinence than usual care (11 versus 5%, OR = 2.17, 95% CI = 0.99-4.77), but the reduction condition was not significantly different from usual care (8 versus 5%, OR = 1.57, 95% CI = 0.69-3.59). At 12 months, the motivational condition had significantly more abstinence than usual care (10 versus 4%, OR = 2.80, 95% CI = 1.14-6.88) and the reduction condition had marginally more abstinence than usual care (9 versus 4%, OR = 2.45, 95% CI = 0.98-6.09). Among adult smokers who are not ready
Slimming World in Stop Smoking Services (SWISSS): study protocol for a randomized controlled trial.
Lycett, Deborah; Aveyard, Paul; Farmer, Andrew; Lewis, Amanda; Munafò, Marcus
2013-06-19
Quitting smokers gain weight. This deters some from trying to stop smoking and may explain the increased incidence of type 2 diabetes after cessation. Dieting when stopping smoking may be counterproductive. Hunger increases cravings for smoking and tackling two behaviours together may undermine quitting success. A meta-analysis of randomized controlled trials (RCTs) showed individualized dietary support may prevent weight gain, although there is insufficient evidence whether it undermines smoking cessation. Commercial weight management providers (CWMPs), such as Slimming World, provide individualized dietary support for National Health Service (NHS) patients; however, there is no evidence that they can prevent cessation-related weight gain.Our objective is to determine whether attending Slimming World from quit date, through referral from NHS Stop Smoking Services, is more effective than usual care at preventing cessation-related weight gain. This RCT will examine the effectiveness of usual cessation support plus referral to Slimming World compared to usual cessation support alone. Healthy weight, overweight and obese adult smokers attending Stop Smoking Services will be included. The primary outcome is weight change in quitters 12 weeks post-randomization. Multivariable linear regression analysis will compare weight change between trial arms and adjust for known predictors of cessation-related weight gain.We will recruit 320 participants, with 160 participants in each arm. An alpha error rate of 5% and 90% power will detect a 2 kg (SD = 2.5) difference in weight gain at 12 weeks, assuming 20% remain abstinent by then. This trial will establish whether referral to the 12-week Slimming World programme plus usual care is an effective intervention to prevent cessation-related weight gain. If so, we will seek to establish whether weight control comes at the expense of a successful quit attempt in a further non-inferiority trial.Positive results from both these trials
Reed, Elizabeth; Myers, Bronwyn; Novak, Scott P; Browne, Felicia A; Wechsberg, Wendee M
2015-01-01
Drug abuse is a contributing factor in women's HIV risk in low-income communities in Cape Town, South Africa. This study assessed whether experiencing violence is associated with reduced drug abstinence among adult women (n = 603) participating in a randomized field trial for an HIV prevention study in Cape Town. In relation to drug abstinence at 12-month follow-up, multivariable regression models were used to assess (1) baseline partner and non-partner victimization, and (2) victimization at 12-month follow-up among participants reporting baseline victimization. Baseline partner (AOR = 0.6; 95 % CI 0.4-0.9) and non-partner victimization (AOR = 0.6; 95 % CI 0.4-0.9) were associated with a reduced likelihood of drug abstinence at follow-up. Among participants who reported victimization at baseline, those no longer reporting victimization at follow-up did not differ significantly in drug abstinence compared with those who reported victimization at follow-up. The study findings highlight the lasting impact of victimization on women's drug use outcomes, persisting regardless of whether violence was no longer reported at follow-up. Overall, the findings support the need for the primary prevention of violence to address the cycle of violence, drug use, and HIV among women in this setting.
Mojarrad, Mohammadali; Samet, Jeffrey H; Cheng, Debbie M.; Winter, Michael R.; Saitz, Richard
2014-01-01
Background Many with alcohol and other drug dependence have concurrent marijuana use, yet it is not clear how to address it during addiction treatment. This is partially due to the lack of clarity about whether marijuana use impacts one’s ability to achieve abstinence from the target of addiction treatment. We examined the association between marijuana use and abstinence from other substances among individuals with substance dependence. Methods A secondary analysis of the Addiction Health Evaluation And Disease management study, a randomized trial testing the effectiveness of chronic disease management. Individuals met criteria for drug or alcohol dependence and reported recent drug (i.e. opioid or stimulant) or heavy alcohol use. Recruitment occurred at an inpatient detoxification unit, and all participants were referred to primary medical care. The association between marijuana use and later abstinence from drug and heavy alcohol use was assessed using longitudinal multivariable models. Results Of 563 study participants, 98% completed at least one follow-up assessment and 535 (95%) had at least one pair of consecutive assessments and were included. In adjusted analyses, marijuana use was associated with a 27% reduction in the odds of abstinence from drug and heavy alcohol use (adjusted odds ratio 0.73 [95% CI, 0.56–0.97], P=0.03). Conclusions Marijuana use among individuals with alcohol or other drug dependence is associated with a lower odds of achieving abstinence from drug and heavy alcohol use. These findings add evidence that suggests concomitant marijuana use among patients with addiction to other drugs merits attention from clinicians. PMID:24986785
Evins, A Eden; Hoeppner, Susanne S; Schoenfeld, David A; Hoeppner, Bettina B; Cather, Corinne; Pachas, Gladys N; Cieslak, Kristina M; Maravic, Melissa Culhane
2017-05-01
To compare the effect of maintenance pharmacotherapy on sustained abstinence rates between recently abstinent smokers with schizophrenia and bipolar disorder (SBD) and general population smokers without psychiatric illness. We performed a person-level, pooled analysis of two randomized controlled trials of maintenance varenicline, conducted in adult smokers with SBD and general population smokers, controlling for severity of dependence. Smokers abstinent after 12-weeks of open varenicline treatment were randomly assigned to ≥12-weeks maintenance varenicline or identical placebo. In those assigned to maintenance placebo, the abstinence rate at week-24 was lower in those with SBD than for those without psychiatric illness (29.4±1.1% vs. 61.8±0.4%, OR:0.26, 95% CI: 0.13, 0.52, p<0.001). In smokers assigned to maintenance pharmacotherapy, however, there was no effect of diagnosis on abstinence rates at week-24 (87.2±0.8% vs. 81.9±0.2%, OR: 1.68, 95% CI: 0.53, 5.32, p=0.38). Time to first lapse was shortest in those with SBD assigned to maintenance placebo (Q1=12days, 95%CI: 4, 16), longer in those without psychiatric illness assigned to maintenance placebo (Q1=17days, 95%CI: 17, 29), still longer in general-population smokers assigned to maintenance varenicline (Q1=88, 95% CI:58,91, and longest in those with SBD who received maintenance varenicline (Q1>95days, 95%CI:non-est), (Χ 2 3df =96.99, p<0.0001; all pairwise comparisons p<0.001). Following a standard 12-week course of pharmacotherapy, people with schizophrenia and bipolar disorder were more likely to relapse to smoking without maintenance varenicline treatment. Maintenance pharmacotherapy could improve longer-term tobacco abstinence rates and reduce known smoking-related health disparities in those with SMI. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.
Opiate v CNS depressant therapy in neonatal drug abstinence syndrome.
Kandall, S R; Doberczak, T M; Mauer, K R; Strashun, R H; Korts, D C
1983-04-01
Paregoric and phenobarbital, administered randomly in 153 passively addicted neonates, initially appeared to control neonatal abstinence signs equally well. However, seven of the 62 phenobarbital-treated newborns had abstinence-associated seizures within the first month of life, while none of 49 paregoric-treated neonates had seizures. Forty-two neonates initially requiring no specific pharmacotherapy for abstinence signs were born to mothers taking less methadone hydrochloride just before delivery. Five of those 42 neonates, however, had seizures within the first 14 days of life. Seizure occurrence could not be predicted from analysis of early abstinence patterns. We consider paregoric to be the treatment of choice for the neonatal abstinence syndrome. Phenobarbital use should be monitored with serum drug levels and modification of recommended dosage regimens considered.
Hallgren, Kevin A; McCrady, Barbara S; Epstein, Elizabeth E
2016-05-01
Drinking urges during treatment for alcohol use disorders (AUDs) are common, can cause distress and predict relapse. Clients may have little awareness of how their drinking urges might be expected to change during AUD treatment in general and in response to initiating abstinence. The aim of the present study was to test whether drinking urges change on a daily level during treatment and after initiating abstinence. Secondary data analysis was performed using daily drinking urge ratings from two randomized clinical trials. Women (n = 98) and men (n = 79) with AUDs in separate clinical trials of out-patient AUD-focused cognitive-behavioral therapy. Daily dichotomous indicators of any drinking urges or acute escalations in urges (i.e. at least two more urges compared with the previous day) were examined using generalized linear mixed growth-curve modeling. Participants who initiated abstinence reported reductions in urges immediately thereafter (log odds ratios: women B = -0.701, P < 0.001; men B = -0.628, P = 0.018), followed by additional, gradual reductions over time (women B = -0.118, P < 0.001; men B = -0.141, P < 0.001). Participants who entered treatment abstaining from alcohol also reported significant reductions in urges over time (women B = -0.147, P < 0.001; men B = -0.142, P < 0.001). Participants who drank throughout treatment had smaller (women B = -0.042, P = 0.012) or no reductions in urges (men B = 0.015, P = 0.545). There was no evidence that urges increased systematically in response to initiating abstinence. Drinking urges during out-patient behavioral treatment for alcohol use disorders may be maintained in part by alcohol consumption. Initiating abstinence is associated with reductions in drinking urges immediately and then more gradually over time. © 2015 Society for the Study of Addiction.
Stanczyk, Nicola E.; Smit, Eline S.; Schulz, Daniela N.; de Vries, Hein; Bolman, Catherine; Muris, Jean W. M.; Evers, Silvia M. A. A.
2014-01-01
Background Although evidence exists for the effectiveness of web-based smoking cessation interventions, information about the cost-effectiveness of these interventions is limited. Objective The study investigated the cost-effectiveness and cost-utility of two web-based computer-tailored (CT) smoking cessation interventions (video- vs. text-based CT) compared to a control condition that received general text-based advice. Methods In a randomized controlled trial, respondents were allocated to the video-based condition (N = 670), the text-based condition (N = 708) or the control condition (N = 721). Societal costs, smoking status, and quality-adjusted life years (QALYs; EQ-5D-3L) were assessed at baseline, six-and twelve-month follow-up. The incremental costs per abstinent respondent and per QALYs gained were calculated. To account for uncertainty, bootstrapping techniques and sensitivity analyses were carried out. Results No significant differences were found in the three conditions regarding demographics, baseline values of outcomes and societal costs over the three months prior to baseline. Analyses using prolonged abstinence as outcome measure indicated that from a willingness to pay of €1,500, the video-based intervention was likely to be the most cost-effective treatment, whereas from a willingness to pay of €50,400, the text-based intervention was likely to be the most cost-effective. With regard to cost-utilities, when quality of life was used as outcome measure, the control condition had the highest probability of being the most preferable treatment. Sensitivity analyses yielded comparable results. Conclusion The video-based CT smoking cessation intervention was the most cost-effective treatment for smoking abstinence after twelve months, varying the willingness to pay per abstinent respondent from €0 up to €80,000. With regard to cost-utility, the control condition seemed to be the most preferable treatment. Probably, more time will be
Smit, Eline Suzanne; de Vries, Hein; Hoving, Ciska
2012-06-11
Distributing a multiple computer-tailored smoking cessation intervention through the Internet has several advantages for both provider and receiver. Most important, a large audience of smokers can be reached while a highly individualized and personal form of feedback can be maintained. However, such a smoking cessation program has yet to be developed and implemented in The Netherlands. To investigate the effects of a Web-based multiple computer-tailored smoking cessation program on smoking cessation outcomes in a sample of Dutch adult smokers. Smokers were recruited from December 2009 to June 2010 by advertising our study in the mass media and on the Internet. Those interested and motivated to quit smoking within 6 months (N = 1123) were randomly assigned to either the experimental (n = 552) or control group (n = 571). Respondents in the experimental group received the fully automated Web-based smoking cessation program, while respondents in the control group received no intervention. After 6 weeks and after 6 months, we assessed the effect of the intervention on self-reported 24-hour point prevalence abstinence, 7-day point prevalence abstinence, and prolonged abstinence using logistic regression analyses. Of the 1123 respondents, 449 (40.0%) completed the 6-week follow-up questionnaire and 291 (25.9%) completed the 6-month follow-up questionnaire. We used a negative scenario to replace missing values. That is, we considered respondents lost to follow-up to still be smoking. The computer-tailored program appeared to have significantly increased 24-hour point prevalence abstinence (odds ratio [OR] 1.85, 95% confidence interval [CI] 1.30-2.65), 7-day point prevalence abstinence (OR 2.17, 95% CI 1.44-3.27), and prolonged abstinence (OR 1.99, 95% CI 1.28-3.09) rates reported after 6 weeks. After 6 months, however, no intervention effects could be identified. Results from complete-case analyses were similar. The results presented suggest that the Web-based computer
Catley, Delwyn; Goggin, Kathy; Harris, Kari Jo; Richter, Kimber P; Williams, Karen; Patten, Christi; Resnicow, Ken; Ellerbeck, Edward F; Bradley-Ewing, Andrea; Lee, Hyoung S; Moreno, Jose L; Grobe, James E
2016-05-01
Despite limitations in evidence, the current Clinical Practice Guideline advocates Motivational Interviewing for smokers not ready to quit. This study evaluated the efficacy of Motivational Interviewing for inducing cessation-related behaviors among smokers with low motivation to quit. Randomized clinical trial. Two-hundred fifty-five daily smokers reporting low desire to quit smoking were recruited from an urban community during 2010-2011 and randomly assigned to Motivational Interviewing, health education, or brief advice using a 2:2:1 allocation. Data were analyzed from 2012 to 2014. Four sessions of Motivational Interviewing utilized a patient-centered communication style that explored patients' own reasons for change. Four sessions of health education provided education related to smoking cessation while excluding elements characteristic of Motivational Interviewing. A single session of brief advice consisted of brief, personalized advice to quit. Self-reported quit attempts; smoking abstinence (biochemically verified); use of cessation pharmacotherapies; motivation; and confidence to quit were assessed at baseline and 3- and 6-month follow-ups. Unexpectedly, no significant differences emerged between groups in the proportion who made a quit attempt by 6-month follow-up (Motivational Interviewing, 52.0%; health education, 60.8%; brief advice, 45.1%; p=0.157). Health education had significantly higher biochemically verified abstinence rates at 6 months (7.8%) than brief advice (0.0%) (8% risk difference, 95% CI=3%, 13%, p=0.003), with the Motivational Interviewing group falling in between (2.9% abstinent, 3% risk difference, 95% CI=0%, 6%, p=0.079). Both Motivational Interviewing and health education groups showed greater increases in cessation medication use, motivation, and confidence to quit relative to brief advice (all p<0.05), and health education showed greater increases in motivation relative to Motivational Interviewing (Cohen's d=0.36, 95% CI=0.12, 0
Psycho-education for substance use and antisocial personality disorder: a randomized trial.
Thylstrup, Birgitte; Schrøder, Sidsel; Hesse, Morten
2015-11-14
Antisocial personality disorder often co-exists with drug and alcohol use disorders. This trial examined the effectiveness of offering psycho-education for antisocial personality disorder in community substance use disorder treatment centers in Denmark. A total of 176 patients were randomly allocated to treatment as usual (TAU, n = 80) or TAU plus a psycho-educative program, Impulsive Lifestyle Counselling (ILC, n = 96) delivered by site clinicians (n = 39). Using follow-up interviews 3 and 9 months after randomization, we examined changes in drug and alcohol use (Addiction Severity Index Composite Scores), percent days abstinent (PDA) within last month, and aggression as measured with the Buss-Perry Aggression Questionnaire-Short Form and the Self-Report of Aggression and Social Behavior Measure. Overall engagement in psychological interventions was modest: 71 (76 %) of participants randomized to psycho-education attended at least one counselling session, and 21 (23 %) attended all six sessions. The Median number of sessions was 2. All patients reduced drug and alcohol problems at 9 months with small within-group effect sizes. Intention-to-treat analyses indicated significant differences between ILC and TAU in mean drugs composite score (p = .018) and in PDA (p = .041) at 3 months. Aggression declined in both groups, but no differences between ILC and TAU were observed in terms of alcohol problems or aggression at any follow-up. Moderate short-term improvements in substance use were associated with randomization to Impulsive Lifestyle Counselling. The findings support the usefulness of providing psycho-education to outpatients with antisocial personality disorder. ISRCTN registry, ISRCTN67266318 , 17/7/2012.
Businelle, Michael S.; Costello, Tracy J.; Castro, Yessenia; Reitzel, Lorraine R.; Vidrine, Jennifer I.; Mullen, Patricia Dolan; Velasquez, Mary M.; Cinciripini, Paul M.; Cofta-Woerpel, Ludmila M.; Wetter, David W.
2010-01-01
Introduction: The purpose of this study was to characterize the relationship between breast feeding and postpartum smoking abstinence among women who quit smoking due to pregnancy and who were participating in a randomized clinical trial of an intervention designed to prevent postpartum relapse. Methods: A total of 251 women were enrolled in the intervention between 30 and 33 weeks postpartum and were followed through 26 weeks postpartum. Participant characteristics were assessed at the prepartum baseline visit, any breast feeding was assessed at 8 weeks postpartum, and smoking abstinence was assessed at 8 and 26 weeks postpartum. Results: Although 79.1% of participants intended to breast feed, only 40.2% reported breast feeding at 8 weeks postpartum. Characteristics associated with breast feeding at 8 weeks postpartum included Caucasian race/ethnicity, greater education, higher household income, and being married/living with a significant other. Logistic regression analysis indicated that breast feeding at 8 weeks postpartum was significantly associated with smoking abstinence at 8 weeks postpartum, odds ratio (OR) = 7.27 (95% CI = 3.27, 16.13), p < .001. Breast feeding at 8 weeks postpartum was also associated with abstinence at 26 weeks postpartum after controlling for smoking status at 8 weeks postpartum, OR = 2.64 (95% CI = 1.14, 6.10), p = .02. Discussion: Encouraging breast feeding among women who quit smoking due to pregnancy may facilitate postpartum smoking abstinence while increasing adherence to current infant feeding guidelines. PMID:20713441
Prah Ruger, Jennifer; Abdallah, Arbi Ben; Luekens, Craig; Cottler, Linda
2012-01-01
Aims To determine whether the additional interventions to standard care are cost-effective in addressing cocaine and alcohol abuse at 4 months (4 M) and 12 months (12 M) from baseline. Method We conducted a cost-effectiveness analysis of a randomized controlled trial with three arms: (1) NIDA's Standard intervention (SI); (2) SI plus a Well Woman Exam (WWE); and, (3) SI, WWE, plus four Educational Sessions (4ES). Results To obtain an additional cocaine abstainer, WWE compared to SI cost $7,223 at 4 M and $3,611 at 12 M. Per additional alcohol abstainer, WWE compared to SI cost $3,611 and $7,223 at 4 M and 12 M, respectively. At 12 M, 4ES was dominated (more costly and less effective) by WWE for abstinence outcomes. Conclusions To our knowledge, this is the first cost-effectiveness analysis simultaneously examining cocaine and alcohol abuse in women. Depending on primary outcomes sought and priorities of policy makers, peer-delivered interventions can be a cost-effective way to address the needs of this growing, underserved population. Trial Registration ClinicalTrials.gov NCT01235091 PMID:22448255
van der Meer, Regina M; Willemsen, Marc C; Smit, Filip; Cuijpers, Pim; Schippers, Gerard M
2010-11-01
To assess whether the addition of a mood management component to telephone counselling produces higher abstinence rates in smokers with past major depression and helps to prevent recurrence of depressive symptoms. Pragmatic randomized controlled trial with two conditions, with follow-up at 6 and 12 months. The control intervention consisted of eight sessions of proactive telephone counselling. The mood management intervention was an integration of the control intervention with a mood management component. This component consisted of a self-help mood management manual, two more preparatory proactive telephone counselling sessions and supplementary homework assignments and advice. Dutch national smoking cessation quitline. A total of 485 daily smokers with past major depression, according to the DSM-IV. The primary outcome measure was prolonged abstinence and secondary outcome measures were 7-day point prevalence abstinence and depressive symptoms. The mood management intervention resulted in significantly higher prolonged abstinence rates at 6- and 12-month follow-up (30.5% and 23.9% in experimental condition, 22.3% and 14.0% in the control condition). The odds ratios were 1.60 (95% CI 1.06-2.42) and 1.96 (95% CI 1.22-3.14) for both follow-ups. The mood management intervention did not seem to prevent recurrence of depressive symptoms. Adding a mood management component to telephone counselling for smoking cessation in smokers with a past major depression increases cessation rates without necessarily reducing depressive symptoms. © 2010 The Authors, Addiction © 2010 Society for the Study of Addiction.
Aveyard, Paul; Wang, Dechao; Connock, Martin; Fry-Smith, Anne; Barton, Pelham; Moore, David
2009-05-01
A Society for Research on Nicotine and Tobacco working group recommended outcome measures for cessation-induction trials and aid-to-cessation trials. Cessation-induction trials aim to motivate unwilling quitters to make a quit attempt. Aid-to-cessation trials give either medication or behavioral interventions to increase the rate at which willing quitters succeed in their attempts. Nicotine-assisted reduction programs combine features of both types of interventions by giving nicotine replacement to unwilling quitters. Treatment can be prolonged more than a year, quit attempts can occur and succeed early or late in the program, and renewed quit attempts are an inherent part of the program. Conventional outcome measures are tied to a fixed but arbitrary point in follow-up and cannot capture the true outcome: Prolonged cessation anchored to the point at which a person makes a successful quit attempt. We propose that the outcome should be counted from the successful quit attempt that began during the treatment period and continues for a defined period, ideally 6 months. In particular, if a trial compared a short reduction program with a long reduction program, it would not be possible to obtain an unbiased assessment of the outcome of such a trial using a measure tied to a fixed point in follow-up. Floating prolonged abstinence could provide such an assessment and is suitable for either prolonged cessation-induction trial or combined cessation-induction and aid-to-cessation trials.
Trigo, Jose M.; Soliman, Alexandra; Quilty, Lena C.; Fischer, Benedikt; Rehm, Jürgen; Selby, Peter; Barnes, Allan J.; Huestis, Marilyn A.; George, Tony P.; Streiner, David L.; Staios, Gregory
2018-01-01
Background The current lack of pharmacological treatments for cannabis use disorder (CUD) warrants novel approaches and further investigation of promising pharmacotherapy. We previously showed that nabiximols (27 mg/ml Δ9-tetrahydrocannabinol (THC)/ 25 mg/ml cannabidiol (CBD), Sativex®) can decrease cannabis withdrawal symptoms. Here, we assessed in a pilot study the tolerability and safety of self-titrated nabiximols vs. placebo among 40 treatment-seeking cannabis-dependent participants. Methods Subjects participated in a double blind randomized clinical trial, with as-needed nabiximols up to 113.4 mg THC/105 mg CBD or placebo daily for 12 weeks, concurrently with Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). Primary outcome measures were tolerability and abstinence, secondary outcome measures were days and amount of cannabis use, withdrawal, and craving scores. Participants received up to CDN$ 855 in compensation for their time. Results Medication was well tolerated and no serious adverse events (SAEs) were observed. Rates of adverse events did not differ between treatment arms (F1,39 = 0.205, NS). There was no significant change in abstinence rates at trial end. Participants were not able to differentiate between subjective effects associated with nabiximols or placebo treatments (F1,40 = 0.585, NS). Cannabis use was reduced in the nabiximols (70.5%) and placebo groups (42.6%). Nabiximols reduced cannabis craving but no significant differences between the nabiximols and placebo groups were observed on withdrawal scores. Conclusions Nabiximols in combination with MET/CBT was well tolerated and allowed for reduction of cannabis use. Future clinical trials should explore the potential of high doses of nabiximols for cannabis dependence. PMID:29385147
Stanczyk, Nicola E; Smit, Eline S; Schulz, Daniela N; de Vries, Hein; Bolman, Catherine; Muris, Jean W M; Evers, Silvia M A A
2014-01-01
Although evidence exists for the effectiveness of web-based smoking cessation interventions, information about the cost-effectiveness of these interventions is limited. The study investigated the cost-effectiveness and cost-utility of two web-based computer-tailored (CT) smoking cessation interventions (video- vs. text-based CT) compared to a control condition that received general text-based advice. In a randomized controlled trial, respondents were allocated to the video-based condition (N = 670), the text-based condition (N = 708) or the control condition (N = 721). Societal costs, smoking status, and quality-adjusted life years (QALYs; EQ-5D-3L) were assessed at baseline, six-and twelve-month follow-up. The incremental costs per abstinent respondent and per QALYs gained were calculated. To account for uncertainty, bootstrapping techniques and sensitivity analyses were carried out. No significant differences were found in the three conditions regarding demographics, baseline values of outcomes and societal costs over the three months prior to baseline. Analyses using prolonged abstinence as outcome measure indicated that from a willingness to pay of €1,500, the video-based intervention was likely to be the most cost-effective treatment, whereas from a willingness to pay of €50,400, the text-based intervention was likely to be the most cost-effective. With regard to cost-utilities, when quality of life was used as outcome measure, the control condition had the highest probability of being the most preferable treatment. Sensitivity analyses yielded comparable results. The video-based CT smoking cessation intervention was the most cost-effective treatment for smoking abstinence after twelve months, varying the willingness to pay per abstinent respondent from €0 up to €80,000. With regard to cost-utility, the control condition seemed to be the most preferable treatment. Probably, more time will be required to assess changes in quality of life
Jacobi, Corinna; Beintner, Ina; Fittig, Eike; Trockel, Mickey; Braks, Karsten; Schade-Brittinger, Carmen; Dempfle, Astrid
2017-09-22
Relapse rates in bulimia nervosa (BN) are high even after successful treatment, but patients often hesitate to take up further treatment. An easily accessible program might help maintain treatment gains. Encouraged by the effects of Web-based eating disorder prevention programs, we developed a manualized, Web-based aftercare program (IN@) for women with BN following inpatient treatment. The objective of this study was to determine the efficacy of the web-based guided, 9-month, cognitive-behavioral aftercare program IN@ for women with BN following inpatient treatment. We conducted a randomized controlled efficacy trial in 253 women with DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, fourth edition) BN and compared the results of IN@ with treatment as usual (TAU). Assessments were carried out at hospital admission (T0), hospital discharge/baseline (T1), postintervention (T2; 9 months after baseline), 9-month follow-up (T3; 18 months after baseline). The primary outcome, abstinence from binge eating and compensatory behaviors during the 2 months preceding T2, was analyzed by intention to treat, using logistic regression analyses. Frequencies of binge eating and vomiting episodes, and episodes of all compensatory behaviors were analyzed using mixed effects models. At T2, data from 167 women were available. There were no significant differences in abstinence rates between the TAU group (n=24, 18.9%) and the IN@ group (n=27, 21.4%; odds ratio, OR=1.29; P=.44). The frequency of vomiting episodes in the IN@ group was significantly (46%) lower than in the TAU group (P=.003). Moderator analyses revealed that both at T2 and T3, women of the intervention group who still reported binge eating and compensatory behaviors after inpatient treatment benefited from IN@, whereas women who were already abstinent after the inpatient treatment did not (P=.004; P=.002). Additional treatment utilization was high in both groups between baseline and follow-up. Overall, data
Hawkins, J. David; Kuklinski, Margaret R.; Fagan, Abigail A.; Fleming, Christopher; Rhew, Isaac C.; Brown, Eric C.; Abbott, Robert D.; Catalano, Richard F.
2016-01-01
This study tested sustained effects of the Communities That Care (CTC) prevention system on health-risking behaviors 9 years after baseline in a community-randomized trial involving 24 towns in seven states. Earlier analyses found sustained effects on abstinence from drug use and delinquency through Grade 12 in a panel of fifth graders. At age 19, 91 % (n = 3986) of the living panel completed the survey. Data were analyzed using generalized linear mixed models. The prevalence of lifetime and current substance use and delinquency were the primary outcomes. Secondary outcomes included substance use disorders, major depression, suicidality, educational attainment, and sexual risk behaviors. CTC had a significant overall effect across lifetime measures of the primary outcomes for males, but not for females or the full sample, although lifetime abstinence from delinquency in the full sample was significantly higher in CTC communities (ARR = 1.16). Males in CTC communities also continued to show greater lifetime abstinence from cigarette smoking (ARR = 1.22). CTC did not have a sustained effect on current substance use and delinquency nor did it improve the secondary outcomes at age 19 for either gender. Communities using CTC may need to extend their prevention planning to include the high school years to sustain effects on drug use and delinquency beyond high school for both genders. PMID:26377418
Effects of incentives for naltrexone adherence on opiate abstinence in heroin-dependent adults
Jarvis, Brantley P.; Holtyn, August F.; DeFulio, Anthony; Dunn, Kelly E.; Everly, Jeffrey J.; Leoutsakos, Jeannie-Marie S.; Umbricht, Annie; Fingerhood, Michael; Bigelow, George E.; Silverman, Kenneth
2017-01-01
Aim To test whether an incentive-based intervention that increased adherence to naltrexone also increased opiate abstinence. Design Post-hoc combined analysis of three earlier randomized controlled trials that individually showed that incentives for adherence to oral and to extended-release injection naltrexone dosing schedules increased naltrexone adherence but not opiate abstinence. Setting Outpatient therapeutic workplace in Baltimore, MD, USA. Participants 140 unemployed heroin-dependent adults participating from 2006–2010. Interventions Participants were hired in a model workplace for 26 weeks and randomized to a Contingency (n=72) or Prescription (n=68) group. Both groups were offered naltrexone. Contingency participants were required to take scheduled doses of naltrexone in order to work and earn wages. Prescription participants could earn wages independent of naltrexone adherence. Measures Thrice-weekly and monthly urine samples tested for opiates and cocaine and measures of naltrexone adherence (percentage of monthly urine samples positive for naltrexone or percentage of scheduled injections received). All analyses included prerandomization attendance, opiate use, and cocaine use as covariates. Additional analyses controlled for cocaine use and naltrexone adherence during the intervention. Findings Contingency participants had more opiate abstinence than Prescription participants (68.1% vs. 52.9% opiate-negative thrice-weekly urine samples, respectively; and 71.9% vs. 61.7% opiate-negative monthly urine samples, respectively) based on initial analyses (thrice-weekly samples, OR = 3.3, 95% CI = 1.7–6.5, p < .01; monthly samples, OR = 2.6, 95% CI = 1.0–7.1, p = .06) and on analyses that controlled for cocaine use (thrice-weekly samples, OR = 3.9, 95% CI = 3.3–4.5, p < .01; monthly samples, OR = 3.4, 95% CI = 1.1–11.1, p =.04), which was high and associated with opiate use. The difference in opiate abstinence rates between Contingency participants
Hoogsteder, Philippe H J; Kotz, Daniel; van Spiegel, Paul I; Viechtbauer, Wolfgang; van Schayck, Onno C P
2014-08-01
Nicotine vaccination has been proposed as a possible treatment to aid smoking cessation. First efficacy results of the nicotine vaccine 3'-AmNic-rEPA (NicVAX) showed that only a subgroup of the top 30% antibody responders achieved higher abstinence rates than placebo. The present study examined the efficacy of adding NicVAX versus placebo to varenicline and behavioural support as an aid in smoking cessation and relapse prevention. Randomized placebo-controlled trial. Two research centres (Maastricht University Medical Centre and Slotervaart Hospital) in the Netherlands. A total of 558 smokers were assigned randomly to six injections with NicVAX (n = 278) or placebo (n = 280) both co-administered with open label varenicline and behavioural support. Outcomes were prolonged carbon monoxide-validated abstinence from weeks 9 to 52 (primary) and weeks 37 to 52 (secondary). We also performed a pre-planned subgroup analysis in the top 30% antibody responders. There was no difference in abstinence rates between NicVAX and placebo from weeks 9 to 52 [27.7 versus 30.0%, odds ratio (OR) = 0.89, 95% confidence interval (CI) = 0.62-1.29] or weeks 37 to 52 (33.8 versus 33.2%, OR = 1.03, 95% CI = 0.73-1.46). The top 30% antibody responders, compared to the placebo group, showed a non-significant tendency towards higher abstinence rates from weeks 37 to 52 (42.2 versus 33.2%, OR = 1.47, 95% CI = 0.89-2.42). The nicotine vaccine, NicVAX, does not appear to improve the chances of stopping smoking when given in addition to varenicline and behavioural support. © 2014 Society for the Study of Addiction.
Tanum, Lars; Solli, Kristin Klemmetsby; Latif, Zill-E-Huma; Benth, Jurate Šaltyte; Opheim, Arild; Sharma-Haase, Kamni; Krajci, Peter; Kunøe, Nikolaj
2017-12-01
To date, extended-release naltrexone hydrochloride has not previously been compared directly with opioid medication treatment (OMT), currently the most commonly prescribed treatment for opioid dependence. To determine whether treatment with extended-release naltrexone will be as effective as daily buprenorphine hydrochloride with naloxone hydrochloride in maintaining abstinence from heroin and other illicit substances in newly detoxified individuals. A 12-week, multicenter, outpatient, open-label randomized clinical trial was conducted at 5 urban addiction clinics in Norway between November 1, 2012, and December 23, 2015; the last follow-up was performed on October 23, 2015. A total of 232 adult opioid-dependent (per DSM-IV criteria) individuals were recruited from outpatient addiction clinics and detoxification units and assessed for eligibility. Intention-to-treat analyses of efficacy end points were performed with all randomized participants. Randomization to either daily oral flexible dose buprenorphine-naloxone, 4 to 24 mg/d, or extended-release naltrexone hydrochloride, 380 mg, administered intramuscularly every fourth week for 12 weeks. Primary end points (protocol) were the randomized clinical trial completion rate, the proportion of opioid-negative urine drug tests, and number of days of use of heroin and other illicit opioids. Secondary end points included number of days of use of other illicit substances. Safety was assessed by adverse event reporting. Of 159 participants, mean (SD) age was 36 (8.6) years and 44 (27.7%) were women. Eighty individuals were randomized to extended-release naltrexone and 79 to buprenorphine-naloxone; 105 (66.0%) completed the trial. Retention in the extended-release naltrexone group was noninferior to the buprenorphine-naloxone group (difference, -0.1; with 95% CI, -0.2 to 0.1; P = .04), with mean (SD) time of 69.3 (25.9) and 63.7 (29.9) days, correspondingly (P = .33, log-rank test). Treatment with extended
Texas Abstinence Educators' Self-Efficacy to Motivate Youth Sexual Abstinence
ERIC Educational Resources Information Center
Rasberry, Catherine N.; Goodson, Patricia; Buhi, Eric R.; Pruitt, B. E.; Wilson, Kelly; Suther, Sandra
2007-01-01
Authors examined self-efficacy to motivate abstinent behavior (among youth) in a sample of instructors teaching abstinence-only-until-marriage education in Texas (N = 104). Sixty-one percent of the sample had been trained/certified to teach abstinence education. Instructors (mostly female and White) were more confident motivating students to…
Park, Elyse R.; Ostroff, Jamie S.; Perez, Giselle K.; Hyland, Kelly A.; Rigotti, Nancy A.; Borderud, Sarah; Regan, Susan; Muzikansky, Alona; Friedman, Emily R.; Levy, Douglas E.; Holland, Susan; Eusebio, Justin; Peterson, Lisa; Rabin, Julia; Miller-Sobel, Jacob; Gonzalez, Irina; Malloy, Laura; O’Brien, Maureen; de León-Sanchez, Suhana; Will Whitlock, C.
2016-01-01
Background Despite the well-established risks of persistent smoking, 10-30% of cancer patients continue to smoke after diagnosis. Evidence based tobacco treatment has yet to be integrated into routine oncology care. This paper describes the protocol, manualized treatment, evaluation plan, and overall study design of comparing the effectiveness and cost of two treatments across two major cancer centers. Methods/Design A two-arm, two-site randomized controlled comparative effectiveness trial is testing the hypothesis that an Intensive Treatment (IT) intervention is more effective than a Standard Treatment (ST) intervention in helping recently diagnosed cancer patients quit smoking. Both interventions include 4 weekly counseling sessions and FDA-approved smoking cessation medication advice. The IT includes an additional 4 biweekly and 3 monthly booster sessions as well as dispensal of the recommended FDA-approved smoking cessation medication at no cost. The trial is enrolling patients with suspected or newly diagnosed cancer who have smoked a cigarette in the past 30 days. Participants are randomly assigned to receive the ST or IT condition. Tobacco cessation outcomes are assessed at 3 and 6 months. The primary study outcome is 7-day point prevalence biochemically-validated tobacco abstinence. Secondary study outcomes include the incremental cost-effectiveness of the IT vs. ST. Discussion This trial will answer key questions about delivering tobacco treatment interventions to newly diagnosed cancer patients. If found to be efficacious and cost-effective, this treatment will serve as a model to be integrated into oncology care settings nation-wide, as we strive to improve treatment outcomes and quality of life for cancer patients. PMID:27444428
Analyzing Milestones in Smoking Cessation: Illustration in a Nicotine Patch Trial in Adult Smokers
ERIC Educational Resources Information Center
Shiffman, Saul; Scharf, Deborah M.; Shadel, William G.; Gwaltney, Chad J.; Dang, Qianyu; Paton, Stephanie M.; Clark, Duncan B.
2006-01-01
Tests of addiction treatments seldom reveal where treatment exercises its effect (i.e., promoting initial abstinence, preventing lapses, and/or impeding progression from lapse to relapse). The authors illustrate analyses distinguishing effects on these milestones in a randomized trial of high-dose nicotine patch (35 mg; n = 188) versus placebo (n…
Randomized trials published in some Chinese journals: how many are randomized?
Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David
2009-07-02
The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9-7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials
Randomized trials published in some Chinese journals: how many are randomized?
Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David
2009-01-01
Background The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. Methods The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. Results From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9–7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely
Sutton, Stephen; Gilbert, Hazel
2007-06-01
To evaluate the effectiveness of individually tailored smoking cessation advice letters as an adjunct to telephone counselling and generic self-help materials. Randomized controlled trial. The UK Quitline. A total of 1508 current smokers and recent ex-smokers. The control group received usual care (telephone counselling and an information pack sent through the post). The intervention group received in addition a computer-generated individually tailored advice letter. All outcomes were assessed at 6-month follow-up. The primary outcome measure was self-reported prolonged abstinence for at least 3 months. Secondary outcomes were self-reported prolonged abstinence for at least 1 month and 7-day and 24-hour point-prevalence abstinence. For the sample as a whole, quit rates did not differ significantly between the two conditions. However, among the majority (n = 1164) who were smokers at baseline, quit rates were consistently higher in the intervention group: prolonged abstinence for 3 months, 12.2% versus 9.0% [odds ratio (OR) = 1.40, 95% confidence interval (CI) = 0.96-2.04, P = 0.080); prolonged abstinence for 1 month, 16.4% versus 11.3% (OR = 1.53, 95% CI = 1.09-2.15, P = 0.013); 7-day point-prevalence abstinence, 18.9% versus 12.7% (OR = 1.59, 95% CI = 1.15-2.19, P = 0.004); 24-hour point-prevalence abstinence, 20.9% versus 15.4% (OR = 1.45, 95% CI = 1.07-1.96, P = 0.015). The results for the smokers are encouraging in showing a small but useful effect of the tailored letter on quit rate. Versions of the tailoring program could be used on the web and in general practices, pharmacies and primary care trusts.
Jones, Matthew; Lewis, Sarah; Parrott, Steve; Wormall, Stephen; Coleman, Tim
2016-06-01
In pregnant smoking cessation trial participants, to estimate (1) among women abstinent at the end of pregnancy, the proportion who re-start smoking at time-points afterwards (primary analysis) and (2) among all trial participants, the proportion smoking at the end of pregnancy and at selected time-points during the postpartum period (secondary analysis). Trials identified from two Cochrane reviews plus searches of Medline and EMBASE. Twenty-seven trials were included. The included trials were randomized or quasi-randomized trials of within-pregnancy cessation interventions given to smokers who reported abstinence both at end of pregnancy and at one or more defined time-points after birth. Outcomes were validated biochemically and self-reported continuous abstinence from smoking and 7-day point prevalence abstinence. The primary random-effects meta-analysis used longitudinal data to estimate mean pooled proportions of re-starting smoking; a secondary analysis used cross-sectional data to estimate the mean proportions smoking at different postpartum time-points. Subgroup analyses were performed on biochemically validated abstinence. The pooled mean proportion re-starting at 6 months postpartum was 43% [95% confidence interval (CI) = 16-72%, I(2) = 96.7%] (11 trials, 571 abstinent women). The pooled mean proportion smoking at the end of pregnancy was 87% (95% CI = 84-90%, I(2) = 93.2%) and 94% (95% CI = 92-96%, I(2) = 88%) at 6 months postpartum (23 trials, 9262 trial participants). Findings were similar when using biochemically validated abstinence. In clinical trials of smoking cessation interventions during pregnancy only 13% are abstinent at term. Of these, 43% re-start by 6 months postpartum. © 2016 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.
Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N
2012-07-01
Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.
Heterogeneity in pathways to abstinence among women in treatment for alcohol use disorder.
Holzhauer, Cathryn Glanton; Epstein, Elizabeth E; Cohn, Amy M; McCrady, Barbara S; Graff, Fiona S; Cook, Sharon
2017-04-01
Although many providers recommend alcohol abstinence as an initial step in the treatment of alcohol use disorders (AUD), there is a scarcity of research on specific behavioral strategies to achieve this step. The current study examined efficacy of a unique abstinence planning intervention for alcohol in a cognitive behavioral therapy (CBT) outpatient protocol. 128 women enrolled in a randomized controlled trial of CBT for AUD at a university-based clinic comprised the sample. Session 1 manual-guided interventions included an abstinence planning discussion in which each woman chose a specific plan for achieving initial abstinence in collaboration with her therapist. Drinking data were collected via participant logs during the 16week within-treatment period and via Timeline Follow-Back interview at 12month follow-up. For 32.8% (n=42) of women who stopped drinking during the pre-treatment assessment period, their abstinence plan was to maintain abstinence (MA). 18.0% (n=23) of women chose a "cold turkey" approach (CT, abrupt cessation without medical assistance), and 46.1% (n=59) chose a "winding down" approach (WD, systematic reduction of drinking toward a specified quit date). Generalized Estimating Equations (GEE) analyses showed that type of abstinence plan chosen was differentially associated with percent days drinking (PDD) in later treatment (weeks 7-16) (p<0.01) and during 12month follow-up (p<0.01). Women in the WD group had the highest PDD for both time frames and women in the CT group drank more frequently during later treatment compared to those in the MA group. The association between plan and PDD during follow-up was moderated by early treatment PDD (weeks 1-7; p<0.01), such that women in the MA and WD groups had lower follow-up PDD if they were able to decrease their drinking during early treatment. Women who were maintaining abstinence at treatment entry or had planned to stop using alcohol abruptly (i.e., "cold turkey") after starting treatment had
Methodological survey of designed uneven randomization trials (DU-RANDOM): a protocol.
Wu, Darong; Akl, Elie A; Guyatt, Gordon H; Devereaux, Philip J; Brignardello-Petersen, Romina; Prediger, Barbara; Patel, Krupesh; Patel, Namrata; Lu, Taoying; Zhang, Yuan; Falavigna, Maicon; Santesso, Nancy; Mustafa, Reem A; Zhou, Qi; Briel, Matthias; Schünemann, Holger J
2014-01-23
Although even randomization (that is, approximately 1:1 randomization ratio in study arms) provides the greatest statistical power, designed uneven randomization (DUR), (for example, 1:2 or 1:3) is used to increase participation rates. Until now, no convincing data exists addressing the impact of DUR on participation rates in trials. The objective of this study is to evaluate the epidemiology and to explore factors associated with DUR. We will search for reports of RCTs published within two years in 25 general medical journals with the highest impact factor according to the Journal Citation Report (JCR)-2010. Teams of two reviewers will determine eligibility and extract relevant information from eligible RCTs in duplicate and using standardized forms. We will report the prevalence of DUR trials, the reported reasons for using DUR, and perform a linear regression analysis to estimate the association between the randomization ratio and the associated factors, including participation rate, type of informed consent, clinical area, and so on. A clearer understanding of RCTs with DUR and its association with factors in trials, for example, participation rate, can optimize trial design and may have important implications for both researchers and users of the medical literature.
Chronic care management for dependence on alcohol and other drugs: the AHEAD randomized trial.
Saitz, Richard; Cheng, Debbie M; Winter, Michael; Kim, Theresa W; Meli, Seville M; Allensworth-Davies, Don; Lloyd-Travaglini, Christine A; Samet, Jeffrey H
2013-09-18
People with substance dependence have health consequences, high health care utilization, and frequent comorbidity but often receive poor-quality care. Chronic care management (CCM) has been proposed as an approach to improve care and outcomes. To determine whether CCM for alcohol and other drug dependence improves substance use outcomes compared with usual primary care. The AHEAD study, a randomized trial conducted among 563 people with alcohol and other drug dependence at a Boston, Massachusetts, hospital-based primary care practice. Participants were recruited from September 2006 to September 2008 from a freestanding residential detoxification unit and referrals from an urban teaching hospital and advertisements; 95% completed 12-month follow-up. Participants were randomized to receive CCM (n=282) or no CCM (n=281). Chronic care management included longitudinal care coordinated with a primary care clinician; motivational enhancement therapy; relapse prevention counseling; and on-site medical, addiction, and psychiatric treatment, social work assistance, and referrals (including mutual help). The no CCM (control) group received a primary care appointment and a list of treatment resources including a telephone number to arrange counseling. The primary outcome was self-reported abstinence from opioids, stimulants, or heavy drinking. Biomarkers were secondary outcomes. There was no significant difference in abstinence from opioids, stimulants, or heavy drinking between the CCM (44%) and control (42%) groups (adjusted odds ratio, 0.84; 95% CI, 0.65-1.10; P=.21). No significant differences were found for secondary outcomes of addiction severity, health-related quality of life, or drug problems. No subgroup effects were found except among those with alcohol dependence, in whom CCM was associated with fewer alcohol problems (mean score, 10 vs 13; incidence rate ratio, 0.85; 95% CI, 0.72-1.00; P=.048). Among persons with alcohol and other drug dependence, CCM compared
Ondersma, Steven J; Svikis, Dace S; Thacker, Leroy R; Beatty, Jessica R; Lockhart, Nancy
2014-01-01
Electronic screening and brief intervention (e-SBI) approaches for substance use have shown early promise. This trial was designed to replicate previous findings from a single 20-minute e-SBI for drug use among postpartum women. A total of 143 postpartum, primarily low-income African-American women meeting criteria for drug use, were randomly assigned to either a tailored e-SBI or a time-matched control condition. Blinded follow-up evaluation 3- and 6-months following childbirth revealed strong effects for confirmed illicit drug use abstinence at the 3-month observation (OR=3.3, p=.01), as did hair analysis at 6months (OR=4.8, p=.018). Additional primary outcomes suggested small to moderate effect sizes in favor of the e-SBI, but did not reach significance. This result replicates previous findings but fails to show durable effects. Assessment reactivity, e-SBI design, and possible extension of e-SBI via tailored messaging all merit careful consideration. © 2013 Elsevier Inc. All rights reserved.
Internet-delivered treatment for substance abuse: a multisite randomized controlled trial.
Campbell, Aimee N C; Nunes, Edward V; Matthews, Abigail G; Stitzer, Maxine; Miele, Gloria M; Polsky, Daniel; Turrigiano, Eva; Walters, Scott; McClure, Erin A; Kyle, Tiffany L; Wahle, Aimee; Van Veldhuisen, Paul; Goldman, Bruce; Babcock, Dean; Stabile, Patricia Quinn; Winhusen, Theresa; Ghitza, Udi E
2014-06-01
Computer-delivered interventions have the potential to improve access to quality addiction treatment care. The objective of this study was to evaluate the effectiveness of the Therapeutic Education System (TES), an Internet-delivered behavioral intervention that includes motivational incentives, as a clinician-extender in the treatment of substance use disorders. Adult men and women (N=507) entering 10 outpatient addiction treatment programs were randomly assigned to receive 12 weeks of either treatment as usual (N=252) or treatment as usual plus TES, with the intervention substituting for about 2 hours of standard care per week (N=255). TES consists of 62 computerized interactive modules covering skills for achieving and maintaining abstinence, plus prize-based motivational incentives contingent on abstinence and treatment adherence. Treatment as usual consisted of individual and group counseling at the participating programs. The primary outcome measures were abstinence from drugs and heavy drinking (measured by twice-weekly urine drug screens and self-report) and time to dropout from treatment. Compared with patients in the treatment-as-usual group, those in the TES group had a lower dropout rate (hazard ratio=0.72, 95% CI=0.57, 0.92) and a greater abstinence rate (odds ratio=1.62, 95% CI=1.12, 2.35). This effect was more pronounced among patients who had a positive urine drug or breath alcohol screen at study entry (N=228) (odds ratio=2.18, 95% CI=1.30, 3.68). Internet-delivered interventions such as TES have the potential to expand access and improve addiction treatment outcomes. Additional research is needed to assess effectiveness in non-specialty clinical settings and to differentiate the effects of the community reinforcement approach and contingency management components of TES.
Skov-Ettrup, Lise S; Dalum, Peter; Bech, Mickael; Tolstrup, Janne S
2016-07-01
To compare the effectiveness of proactive telephone counselling, reactive telephone counselling and an internet- and text-message-based intervention with a self-help booklet for smoking cessation. A randomized controlled trial with equal allocation to four conditions: (1) proactive telephone counselling (n = 452), (2) reactive telephone counselling (n = 453), (3) internet- and text-message-based intervention (n = 453) and (4) self-help booklet (control) (n = 452). Denmark. Smokers who had participated previously in two national health surveys were invited. Eligibility criteria were daily cigarette smoking, age ≥ 16 years, having a mobile phone and e-mail address. Primary outcome was prolonged abstinence to 12 months from the end of the intervention period. At 12-month follow-up, higher prolonged abstinence was found in the proactive telephone counselling group compared with the booklet group [7.3 versus 3.6%, odds ratio (OR) = 2.2, 95% confidence interval (CI) = 1.2-4.0]. There was no clear evidence of a difference in prolonged abstinence between the reactive telephone counselling group or the internet-based smoking cessation program and the booklet group: 1.8 versus 3.6%, OR = 0.8, 95% CI = 0.6-1.2 and 5.3 versus 3.6%, OR = 1.6, 95% CI = 0.8-3.0, respectively. In the proactive telephone counselling group, the cost per additional 12-month quitter compared with the booklet group was £644. Proactive telephone counselling was more effective than a self-help booklet in achieving prolonged abstinence for 12 months. No clear evidence of an effect of reactive telephone counselling or the internet- and text-message-based intervention was found compared with the self-help booklet. © 2016 Society for the Study of Addiction.
van Rossem, Carolien; Spigt, Mark; Viechtbauer, Wolfgang; Lucas, Annelies E M; van Schayck, Onno C P; Kotz, Daniel
2017-12-01
To study the effectiveness of intensive counselling by a practice nurse (PN) versus brief advice by a general practitioner (GP), each combined with pharmacotherapy, for 6 months' tobacco abstinence (primary outcome). Secondary outcomes included 12-month abstinence, medication adherence and incremental costs per life-year gained. A multi-site (n = 10), two-group, parallel, pragmatic randomized controlled trial. A network of primary health-care centres in the Netherlands. A total of 295 adult daily smokers (mean age = 48 years; mean cigarettes/day = 19). Patients were randomized to receive individual counselling by a practice nurse (PN) (n = 149) or brief advice by a general practitioner (GP) (146). All patients received 12 weeks of open-label varenicline. The primary outcome was prolonged biochemically validated abstinence from weeks 9 to 26 after treatment initiation. Secondary outcomes included abstinence from weeks 9 to 52, good dosing adherence (> 80% days taken) and incremental costs per life-year gained. Abstinence rates in the PN versus GP groups were 32.2% (n = 48) versus 39.0% [n = 57; odds ratio (OR) = 0.71; 95% confidence interval (CI) = 0.44-1.16] from weeks 9 to 26 and 25.5% (n = 38) versus 28.8% (n = 42; OR = 0.84, 95% CI = 0.50-1.43) from weeks 9 to 52, respectively. Values of the Bayes factor indicated that the PN and GP were equally effective. Good dosing adherence was significantly lower in the PN (45.5%, n = 56/123) than in the GP group (62.0%, n = 75/121; OR = 0.45, 95% CI = 0.26-0.77), and the incremental costs per life-year gained were -€416.10. Among people seeking help to stop smoking from their general practice, one-off brief advice from a general practitioner appears to be as effective as several sessions of behavioural support from a practice nurse when smoking cessation medication is provided. © 2017 Society for the Study of Addiction.
Graham, Amanda L; Papandonatos, George D; Erar, Bahar; Stanton, Cassandra A
2015-12-01
We estimated the causal effects of use of an online smoking cessation community on 30-day point prevalence abstinence at 3 months. Participants (N = 492) were adult current smokers in the enhanced Internet arm of The iQUITT Study, a randomized trial of Internet and telephone treatment for smoking cessation. All participants accessed a Web-based smoking-cessation program that included a large, established online community. Automated tracking metrics of passive (e.g., reading forum posts, viewing member profiles) and active (e.g., writing forum posts, sending private messages) community use were extracted from the site at 3 months. Self-selected community use defines the groups of interest: "None," "Passive," and "Both" (passive + active). Inverse probability of treatment weighting corrected for baseline imbalances on demographic, smoking, psychosocial, and medical history variables. Propensity weights estimated via generalized boosted models were used to calculate Average Treatment Effects (ATE) and Average Treatment effects on the Treated (ATT). Patterns of community use were: None = 198 (40.2%), Passive = 110 (22.4%), and Both = 184 (37.4%). ATE-weighted abstinence rates were: None = 4.2% (95% CI = 1.5-6.9); Passive = 15.1% (95% CI = 8.4-21.9); Both = 20.4% (95% CI = 13.9-26.8). ATT-weighted abstinence rates indicated even greater benefits of community use. Community users were more likely to quit smoking at 3 months than nonusers. The estimated benefit from use of online community resources was even larger among subjects with high propensity to use them. No differences in abstinence emerged between passive and passive/active users. Results suggest that lurking in online communities confers specific abstinence benefits. Implications of these findings for online cessation communities are discussed. (PsycINFO Database Record (c) 2015 APA, all rights reserved).
Wan, Li-Hong; Zhang, Xiao-Pei; Mo, Miao-Miao; Xiong, Xiao-Ni; Ou, Cui-Ling; You, Li-Ming; Chen, Shao-Xian; Zhang, Min
2016-09-01
Adopting healthy behaviors is critical for secondary stroke prevention, but many patients fail to follow national guidelines regarding diet, exercise, and abstinence from risk factors. Compliance often decreases with time after hospital discharge, yet few studies have examined programs promoting long-term adherence to health behaviors. Goal setting and telephone follow-up have been proven to be effective in other areas of medicine, so this study evaluated the effectiveness of a guideline-based, goal-setting telephone follow-up program for patients with ischemic stroke. This was a multicenter, assessor-blinded, parallel-group, randomized controlled trial. Ninety-one stroke patients were randomized to either a control group or an intervention group. Intervention consisted of predischarge education and 3 goal-setting follow-up sessions conducted by phone. Data were collected at baseline and during the third and sixth months after hospital discharge. Six months after discharge, patients in the intervention group exhibited significantly higher medication adherence than patients in the control group. There were no statistically significant differences in physical activity, nutrition, low-salt diet adherence, blood pressure monitoring, smoking abstinence, unhealthy use of alcohol, and modified Rankin Scale (mRS) scores between the 2 groups. Goal-setting telephone follow-up intervention for ischemic stroke patients is feasible and leads to improved medication adherence. However, the lack of group differences in other health behavior subcategories and in themRS score indicates a need for more effective intervention strategies to help patients reach guideline-recommended targets. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.
McGovern, Mark P; Lambert-Harris, Chantal; Xie, Haiyi; Meier, Andrea; McLeman, Bethany; Saunders, Elizabeth
2015-07-01
Post-traumatic stress disorder (PTSD) is common among people with substance use disorders, and the comorbidity is associated with negative outcomes. We report on a randomized controlled trial comparing the effect of integrated cognitive-behavioral therapy (ICBT) plus standard care, individual addiction counseling plus standard care and standard care alone on substance use and PTSD symptoms. Three-group, multi-site randomized controlled trial. Seven addiction treatment programs in Vermont and New Hampshire, USA. Recruitment took place between December 2010 and January 2013. In this single-blind study, 221 participants were randomized to one of three conditions: ICBT plus standard care (SC) (n = 73), individual addiction counseling (IAC) plus SC (n = 75) or SC only (n = 73). One hundred and seventy-two patients were assessed at 6-month follow-up (58 ICBT; 61 IAC; 53 SC). Intervention and comparators: ICBT is a manual-guided therapy focused on PTSD and substance use symptom reduction with three main components: patient education, mindful relaxation and flexible thinking. IAC is a manual-guided therapy focused exclusively on substance use and recovery with modules organized in a stage-based approach: treatment initiation, early abstinence, maintaining abstinence and recovery. SC are intensive out-patient program services that include 9-12 hours of face-to-face contact per week over 2-4 days of group and individual therapies plus medication management. Primary outcomes were PTSD severity and substance use severity at 6 months. Secondary outcomes were therapy retention. PTSD symptoms reduced in all conditions with no difference between them. In analyses of covariance, ICBT produced more favorable outcomes on toxicology than IAC or SC [comparison with IAC, parameter estimate: 1.10; confidence interval (CI) = 0.17-2.04; comparison with SC, parameter estimate: 1.13; CI = 0.18-2.08] and had a greater reduction in reported drug use than SC (parameter estimate: -9.92; CI =
Giovancarli, Camille; Malbos, Eric; Baumstarck, Karine; Parola, Nathalie; Pélissier, Marie-Florence; Lançon, Christophe; Auquier, Pascal; Boyer, Laurent
2016-02-19
Successful interventions have been developed for smoking cessation, but the success of smoking relapse prevention interventions has been limited. In particular, cognitive behavioural therapy (CBT) has been hampered by a high relapse rate. Because relapses can be due to the presence of conditions associated with tobacco consumption (such as drinking in bars with friends), virtual reality exposure therapy (VRET) can generate synthetic environments that represent risk situations for the patient in the context of relapse prevention. The primary objective of this study is to evaluate the effectiveness of CBT coupled with VRET, in comparison to CBT alone, in the prevention of smoking relapse. The secondary objectives are to assess the impact of CBT coupled with VRET on anxiety, depression, quality of life, self-esteem and addictive comorbidities (such as alcohol, cannabis, and gambling). A third objective examines the feasibility and acceptability of VR use considering elements such as presence, cybersickness and number of patients who complete the VRET program. The present study is a 14-month (2 months of therapy followed by 12 months of follow-up), prospective, comparative, randomized and open clinical trial, involving two parallel groups (CBT coupled with VRET versus CBT alone). The primary outcome is the proportion of individuals with tobacco abstinence at 6 months after the end of the therapy. Abstinence is defined by the total absence of tobacco consumption assessed during a post-test interview and with an apparatus that measures the carbon monoxide levels expired. A total of 60 individuals per group will be included. This study is the first to examine the efficacy of CBT coupled with VRET in the prevention of smoking relapse. Because VRET is simple to use and has a low cost, this interactive therapeutic method might be easily implemented in clinical practice if the study confirms its efficacy. ClinicalTrials.gov Identifier: NCT02205060 (registered 25 July 2014).
Glass, Joseph E; McKay, James R; Gustafson, David H; Kornfield, Rachel; Rathouz, Paul J; McTavish, Fiona M; Atwood, Amy K; Isham, Andrew; Quanbeck, Andrew; Shah, Dhavan
2017-06-01
We estimated the efficacy of the Addiction-Comprehensive Health Enhancement Support System (A-CHESS) in increasing the use of services for addiction and examined the extent to which this use of services mediated the effects of A-CHESS on risky drinking days and abstinence from drinking. We conducted secondary data analyses of the A-CHESS randomized controlled trial. Recruitment occurred in five residential treatment programs operated by two addiction treatment organizations. Participants were 349 adults with alcohol use disorders recruited two weeks before discharge from residential treatment. We provided intervention arm participants with a smartphone, the A-CHESS application, and an 8-month service plan. Control arm participants received treatment as usual. Telephone interviews at 4, 8, and 12-month follow-ups assessed past-month risky drinking days, past-month abstinence, and post-discharge service utilization (past-month outpatient addiction treatment and past-week mutual help including Alcoholics Anonymous and Narcotics Anonymous). Using mixed effects latent variable models, we estimated the indirect effects of A-CHESS on drinking outcomes, as mediated by post-discharge service utilization. Approximately 50.5% of participants reported outpatient addiction treatment and 75.5% reported mutual help at any follow-up interview in the year following randomization. Assignment to the A-CHESS intervention was associated with an increased odds of outpatient addiction treatment across follow-ups, but not mutual help. This use of outpatient addiction treatment mediated the effect of A-CHESS on risky drinking days, but not abstinence. The effect of A-CHESS through outpatient addiction treatment appeared to reduce the expected number of risky drinking days across follow-ups by 11%. The mobile health (mHealth) intervention promoted the use of outpatient addiction treatment, which appeared to contribute to its efficacy in reducing risky drinking. Future research should
Kelly, John F; Kaminer, Yifrah; Kahler, Christopher W; Hoeppner, Bettina; Yeterian, Julie; Cristello, Julie V; Timko, Christine
2017-12-01
The integration of 12-Step philosophy and practices is common in adolescent substance use disorder (SUD) treatment programs, particularly in North America. However, although numerous experimental studies have tested 12-Step facilitation (TSF) treatments among adults, no studies have tested TSF-specific treatments for adolescents. We tested the efficacy of a novel integrated TSF. Explanatory, parallel-group, randomized clinical trial comparing 10 sessions of either motivational enhancement therapy/cognitive-behavioral therapy (MET/CBT; n = 30) or a novel integrated TSF (iTSF; n = 29), with follow-up assessments at 3, 6 and 9 months following treatment entry. Out-patient addiction clinic in the United States. Adolescents [n = 59; mean age = 16.8 (1.7) years; range = 14-21; 27% female; 78% white]. The iTSF integrated 12-Step with motivational and cognitive-behavioral strategies, and was compared with state-of-the-art MET/CBT for SUD. Primary outcome: percentage days abstinent (PDA); secondary outcomes: 12-Step attendance, substance-related consequences, longest period of abstinence, proportion abstinent/mostly abstinent, psychiatric symptoms. Primary outcome: PDA was not significantly different across treatments [b = 0.08, 95% confidence interval (CI) = -0.08 to 0.24, P = 0.33; Bayes' factor = 0.28). during treatment, iTSF patients had substantially greater 12-Step attendance, but this advantage declined thereafter (b = -0.87; 95% CI = -1.67 to 0.07, P = 0.03). iTSF did show a significant advantage at all follow-up points for substance-related consequences (b = -0.42; 95% CI = -0.80 to -0.04, P < 0.05; effect size range d = 0.26-0.71). Other secondary outcomes did not differ significantly between treatments, but effect sizes tended to favor iTSF. Throughout the entire sample, greater 12-Step meeting attendance was associated significantly with longer abstinence during (r = 0.39, P = 0.008), and early following (r = 0.30, P = 0
Functional MRI of inhibitory processing in abstinent adolescent marijuana users.
Tapert, Susan F; Schweinsburg, Alecia D; Drummond, Sean P A; Paulus, Martin P; Brown, Sandra A; Yang, Tony T; Frank, Lawrence R
2007-10-01
Marijuana intoxication appears to impair response inhibition, but it is unclear if impaired inhibition and associated brain abnormalities persist after prolonged abstinence among adolescent users. We hypothesized that brain activation during a go/no-go task would show persistent abnormalities in adolescent marijuana users after 28 days of abstinence. Adolescents with (n = 16) and without (n = 17) histories of marijuana use were compared on blood oxygen level dependent (BOLD) response to a go/no-go task during functional magnetic resonance imaging (fMRI) after 28 days of monitored abstinence. Participants had no neurological problems or Axis I diagnoses other than cannabis abuse/dependence. Marijuana users did not differ from non-users on task performance but showed more BOLD response than non-users during inhibition trials in right dorsolateral prefrontal, bilateral medial frontal, bilateral inferior and superior parietal lobules, and right occipital gyri, as well as during "go" trials in right prefrontal, insular, and parietal cortices (p < 0.05, clusters > 943 microl). Differences remained significant even after controlling for lifetime and recent alcohol use. Adolescent marijuana users relative to non-users showed increased brain processing effort during an inhibition task in the presence of similar task performance, even after 28 days of abstinence. Thus, increased brain processing effort to achieve inhibition may predate the onset of regular use or result from it. Future investigations will need to determine whether increased brain processing effort is associated with risk to use.
Cunningham, John A; Leatherdale, Scott T; Selby, Peter L; Tyndale, Rachel F; Zawertailo, Laurie; Kushnir, Vladyslav
2011-09-28
Considerable public health efforts are ongoing Canada-wide to reduce the prevalence of smoking in the general population. From 1985 to 2005, smoking rates among adults decreased from 35% to 19%, however, since that time, the prevalence has plateaued at around 18-19%. To continue to reduce the number of smokers at the population level, one option has been to translate interventions that have demonstrated clinical efficacy into population level initiatives. Nicotine Replacement Therapy (NRT) has a considerable clinical research base demonstrating its efficacy and safety and thus public health initiatives in Canada and other countries are distributing NRT widely through the mail. However, one important question remains unanswered--do smoking cessation programs that involve mailed distribution of free NRT work? To answer this question, a randomized controlled trial is required. A single blinded, panel survey design with random assignment to an experimental and a control condition will be used in this study. A two-stage recruitment process will be employed, in the context of a general population survey with two follow-ups (8 weeks and 6 months). Random digit dialing of Canadian home telephone numbers will identify households with adult smokers (aged 18+ years) who are willing to take part in a smoking study that involves three interviews, with saliva collection for 3-HC/cotinine ratio measurement at baseline and saliva cotinine verification at 8-week and 6-month follow-ups (N = 3,000). Eligible subjects interested in free NRT will be determined at baseline (N = 1,000) and subsequently randomized into experimental and control conditions to receive versus not receive nicotine patches. The primary hypothesis is that subjects who receive nicotine patches will display significantly higher quit rates (as assessed by 30 day point prevalence of abstinence from tobacco) at 6-month follow-up as compared to subjects who do not receive nicotine patches at baseline. The findings
Manning, Victoria; Staiger, Petra K; Hall, Kate; Garfield, Joshua B B; Flaks, Gabriella; Leung, Daniel; Hughes, Laura K; Lum, Jarrad A G; Lubman, Dan I; Verdejo-Garcia, Antonio
2016-09-01
Relapse is common in alcohol-dependent individuals and can be triggered by alcohol-related cues in the environment. It has been suggested that these individuals develop cognitive biases, in which cues automatically capture attention and elicit an approach action tendency that promotes alcohol seeking. The study aim was to examine whether cognitive bias modification (CBM) training targeting approach bias could be delivered during residential alcohol detoxification and improve treatment outcomes. Using a 2-group parallel-block (ratio 1:1) randomized controlled trial with allocation concealed to the outcome assessor, 83 alcohol-dependent inpatients received either 4 sessions of CBM training where participants were implicitly trained to make avoidance movements in response to pictures of alcoholic beverages and approach movements in response to pictures of nonalcoholic beverages, or 4 sessions of sham training (controls) delivered over 4 consecutive days during the 7-day detoxification program. The primary outcome measure was continuous abstinence at 2 weeks postdischarge. Secondary outcomes included time to relapse, frequency and quantity of alcohol consumption, and craving. Outcomes were assessed in a telephonic follow-up interview. Seventy-one (85%) participants were successfully followed up, of whom 61 completed all 4 training sessions. With an intention-to-treat approach, there was a trend for higher abstinence rates in the CBM group relative to controls (69 vs. 47%, p = 0.07); however, a per-protocol analysis revealed significantly higher abstinence rates among participants completing 4 sessions of CBM relative to controls (75 vs. 45%, p = 0.02). Craving score, time to relapse, mean drinking days, and mean standard drinks per drinking day did not differ significantly between the groups. This is the first trial demonstrating the feasibility of CBM delivered during alcohol detoxification and supports earlier research suggesting it may be a useful, low
Roberts, Vaughan; Gant, Nicholas; Sollers, John J; Bullen, Chris; Jiang, Yannan; Maddison, Ralph
2015-03-01
Exercise has been shown to attenuate cigarette cravings during temporary smoking abstinence; however, the mechanisms of action are not clearly understood. The objectives of the study were to compare the effects of three exercise intensities on desire to smoke and explore potential neurobiological mediators of desire to smoke. Following overnight abstinence, 40 participants (25 males, 18-59 years) completed three 15 min sessions of light-, moderate-, or vigorous-intensity exercise on a cycle ergometer in a randomized crossover design. Ratings of desire to smoke were self-reported pre- and post-exercise and heart rate variability was measured throughout. Saliva and blood were analyzed for cortisol and noradrenaline in a sub-sample. Exercise influenced desire to smoke (F [2, 91] = 7.94, p < 0.01), with reductions greatest immediately after vigorous exercise. There were also significant time x exercise intensity interaction effects for heart rate variability and plasma noradrenaline (F [8, 72] = 2.23, p = 0.03), with a bias in noradrenaline occurring between light and vigorous conditions (adjusted mean difference [SE] = 2850 ng/ml [592], p < 0.01) at 5 min post-exercise. There was no interaction of time x exercise intensity for plasma and salivary cortisol levels. These findings support the use of vigorous exercise to reduce cigarette cravings, showing potential alterations in a noradrenergic marker.
Cooney, Ned L; Cooney, Judith L; Perry, Bridget L; Carbone, Michael; Cohen, Emily H; Steinberg, Howard R; Pilkey, David T; Sevarino, Kevin; Oncken, Cheryl A; Litt, Mark D
2009-09-01
The primary aim was to compare the efficacy of smoking cessation treatment using a combination of active nicotine patch plus active nicotine gum versus therapy consisting of active nicotine patch plus placebo gum in a sample of alcohol-dependent tobacco smokers in an early phase of out-patient alcohol treatment. A secondary aim was to determine whether or not there were any carry-over effects of combination nicotine replacement on drinking outcomes. Small-scale randomized double-blind placebo-controlled clinical trial with 1-year smoking and drinking outcome assessment. Two out-patient substance abuse clinics provided a treatment platform of behavioral alcohol and smoking treatment delivered in 3 months of weekly sessions followed by three monthly booster sessions. Participants were 96 men and women with a diagnosis of alcohol abuse or dependence and smoking 15 or more cigarettes per day. All participants received open-label transdermal nicotine patches and were randomized to receive either 2 mg nicotine gum or placebo gum under double-blind conditions. Analysis of 1-year follow-up data revealed that patients receiving nicotine patch plus active gum had better smoking outcomes than those receiving patch plus placebo gum on measures of time to smoking relapse and prolonged abstinence at 12 months. Alcohol outcomes were not significantly different across medication conditions. Results of this study were consistent with results of larger trials of smokers without alcohol problems, showing that combination therapy (nicotine patch plus gum) is more effective than monotherapy (nicotine patch) for smoking cessation.
A pilot randomized controlled trial of deprescribing.
Beer, Christopher; Loh, Poh-Kooi; Peng, Yan Gee; Potter, Kathleen; Millar, Alasdair
2011-04-01
Polypharmacy and adverse drug reactions are frequent and important among older people. Few clinical trials have evaluated systematic withdrawal of medications among older people. This small, open, study was conducted to determine the feasibility of a randomized controlled deprescribing trial. Ten volunteers living in the community (recruited by media advertising) and 25 volunteers living in residential aged-care facilities (RCFs) were randomized to intervention or control groups. The intervention was gradual withdrawal of one target medication. The primary outcome was the number of intervention participants in whom medication withdrawal could be achieved. Other outcomes measures were quality of life, medication adherence, sleep quality, and cognitive impairment. Participants were aged 80 ± 11 years and were taking 9 ± 2 medications. Fifteen participants commenced medication withdrawal and all ceased or reduced the dose of their target medication. Two subjects withdrew; one was referred for clinical review, and one participant declined further dose reductions. A randomized controlled trial of deprescribing was acceptable to participants. Recruitment in RCFs is feasible. Definitive trials of deprescribing are required.
Abstinence versus Moderation Goals in Brief Motivational Treatment for Pathological Gambling.
Stea, Jonathan N; Hodgins, David C; Fung, Tak
2015-09-01
The present study examined the nature and impact of participant goal selection (abstinence versus moderation) in brief motivational treatment for pathological gambling via secondary analyses from a randomized controlled trial. The results demonstrated that the pattern of goal selection over time could be characterized by both fluidity and stability, whereby almost half of participants switched their goal at least one time, over 25% of participants selected an unchanging goal of 'quit most problematic type of gambling', almost 20% selected an unchanging goal of 'quit all types of gambling', and approximately 10% selected an unchanging goal of 'gamble in a controlled manner.' The results also demonstrated that pretreatment goal selection was uniquely associated with three variables, whereby compared to participants who selected the goal to 'cut back on problem gambling', those who selected the goal to 'quit problem gambling' were more likely to have greater gambling problem severity, to have identified video lottery terminal play as problematic, and to have greater motivation to overcome their gambling problem. Finally, the results demonstrated that goal selection over time had an impact on the average number of days gambled over the course of treatment, whereby those with abstinence-based goals gambled significantly fewer days than those with moderation-based goals. Nevertheless, goal selection over time was not related to dollars gambled, dollars per day gambled, or perceived goal achievement. The findings do not support the contention that abstinence-based goals are more advantageous than moderation goals and are discussed in relation to the broader alcohol treatment literature.
A Deposit Contract Method to Deliver Abstinence Reinforcement for Cigarette Smoking
ERIC Educational Resources Information Center
Dallery, Jesse; Meredith, Steven; Glenn, Irene M.
2008-01-01
Eight smokers were randomly assigned to a deposit contract ($50.00) or to a no-deposit group. Using a reversal design, participants could recoup their deposit (deposit group) or earn vouchers (no-deposit group) for smoking reductions and abstinence (breath carbon monoxide [CO] less than or equal to 4 parts per million) during treatment phases.…
Lycett, Deborah; Hajek, Peter; Aveyard, Paul
2010-10-07
Weight gain accompanies smoking cessation, but dieting during quitting is controversial as hunger may increase urges to smoke. This is a feasibility trial for the investigation of a very low calorie diet (VLCD), individual modest energy restriction, and usual advice on hunger, ketosis, urges to smoke, abstinence and weight gain in overweight smokers trying to quit. This is a 3 armed, unblinded, randomized controlled trial in overweight (BMI > 25 kg/m2), daily smokers (CO > 10 ppm); with at least 30 participants in each group. Each group receives identical behavioural support and NRT patches (25 mg(8 weeks),15 mg(2 weeks),10 mg(2 weeks)). The VLCD group receive a 429-559 kcal/day liquid formula beginning 1 week before quitting and continuing for 4 weeks afterwards. The modest energy restricted group (termed individual dietary and activity planning(IDAP)) engage in goal-setting and receive an energy prescription based on individual basal metabolic rate(BMR) aiming for daily reduction of 600 kcal. The control group receive usual dietary advice that accompanies smoking cessation i.e. avoiding feeling hungry but eating healthy snacks. After this, the VLCD participants receive IDAP to provide support for changing eating habits in the longer term; the IDAP group continues receiving this support. The control group receive IDAP 8 weeks after quitting. This allows us to compare IDAP following a successful quit attempt with dieting concurrently during quitting. It also aims to prevent attrition in the unblinded, control group by meeting their need for weight management. Follow-up occurs at 6 and 12 months.Outcome measures include participant acceptability, measured qualitatively by semi-structured interviewing and quantitatively by recruitment and attrition rates. Feasibility of running the trial within primary care is measured by interview and questionnaire of the treatment providers. Adherence to the VLCD is verified by the presence of urinary ketones measured weekly. Daily
ERIC Educational Resources Information Center
Williams, Geoffrey C.; Niemiec, Christopher P.; Patrick, Heather; Ryan, Richard M.; Deci, Edward L.
2016-01-01
A pragmatic comparative effectiveness trial examined whether extending the duration of a cost-effective, intensive tobacco-dependence intervention designed to support autonomy will facilitate long-term tobacco abstinence. Participants were randomly assigned to one of three tobacco-dependence interventions based on self-determination theory,…
El Hajj, Maguy Saffouh; Kheir, Nadir; Al Mulla, Ahmad Mohd; Shami, Rula; Fanous, Nadia; Mahfoud, Ziyad R
2017-02-20
Cigarette smoking is one of the major preventable causes of death and diseases in Qatar. The study objective was to test the effect of a structured smoking cessation program delivered by trained pharmacists on smoking cessation rates in Qatar. A prospective randomized controlled trial was conducted in eight ambulatory pharmacies in Qatar. Eligible participants were smokers 18 years and older who smoked one or more cigarettes daily for 7 days, were motivated to quit, able to communicate in Arabic or English, and attend the program sessions. Intervention group participants met with the pharmacists four times at 2 to 4 week intervals. Participants in the control group received unstructured brief smoking cessation counseling. The primary study outcome was self-reported continuous abstinence at 12 months. Analysis was made utilizing data from only those who responded and also using intent-to-treat principle. A multinomial logistic regression model was fitted to assess the predictors of smoking at 12 months. Analysis was conducted using IBM-SPSS® version 23 and STATA® version 12. A total of 314 smokers were randomized into two groups: intervention (n = 167) and control (n = 147). Smoking cessation rates were higher in the intervention group at 12 months; however this difference was not statistically significant (23.9% vs. 16.9% p = 0.257). Similar results were observed but with smaller differences in the intent to treat analysis (12.6% vs. 9.5%, p = 0.391). Nevertheless, the daily number of cigarettes smoked for those who relapsed was significantly lower (by 4.7 and 5.6 cigarettes at 3 and 6 months respectively) in the intervention group as compared to the control group (p = 0.041 and p = 0.018 respectively). At 12 months, the difference was 3.2 cigarettes in favor of the intervention group but was not statistically significant (p = 0.246). Years of smoking and daily number of cigarettes were the only predictors of smoking as opposed
Hickman, Norval J; Delucchi, Kevin L; Prochaska, Judith J
2015-08-01
In an ethnically-diverse, uninsured psychiatric sample with co-occurring drug/alcohol addiction, we evaluated the feasibility and reproducibility of a tobacco treatment intervention. The intervention previously demonstrated efficacy in insured psychiatric and nonpsychiatric samples with 20.0%-25.0% abstinence at 18 months. Daily smokers, recruited in 2009-2010 from psychiatric units at an urban public hospital, were randomized to usual care (on-unit nicotine replacement plus quit advice) or intervention, which added a Transtheoretical-model tailored, computer-assisted intervention, stage-matched manual, brief counseling, and 10-week post-hospitalization nicotine replacement. The sample (N = 100, 69% recruitment rate, age M = 40) was 56% racial/ethnic minority, 65% male, 79% unemployed, and 48% unstably housed, diagnosed with unipolar (54%) and bipolar (14%) depression and psychotic disorders (46%); 77% reported past-month illicit drug use. Prior to hospitalization, participants averaged 19 (SD = 11) cigarettes/day for 23 (SD = 13) years; 80% smoked within 30 minutes of awakening; 25% were preparing to quit. Encouraging and comparable to effects in the general population, 7-day point prevalence abstinence for intervention versus control was 12.5% versus 7.3% at 3 months, 17.5% versus 8.5% at 6 months, and 26.2% versus 16.7% at 12 months. Retention exceeded 80% over 12 months. The odds of abstinence increased over time, predicted by higher self-efficacy, greater perceived social status, and diagnosis of psychotic disorder compared to unipolar depression. Findings indicate uninsured smokers with serious mental illness can engage in tobacco treatment research with quit rates comparable to the general population. A larger investigation is warranted. Inclusion of diverse smokers with mental illness in clinical trials is supported and encouraged. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All
Hassandra, Mary; Lintunen, Taru; Kettunen, Tarja; Vanhala, Mauno; Toivonen, Hanna-Mari; Kinnunen, Kimmo; Heikkinen, Risto
2015-10-22
Results from studies on the effects of exercise on smoking-related variables have provided strong evidence that physical activity acutely reduces cigarette cravings. Mobile technology may provide some valuable tools to move from explanatory randomized controlled trials to pragmatic randomized controlled trials by testing the acute effectiveness of exercise on quitters under real-life conditions. An mHealth app was developed to be used as a support tool for quitters to manage their cigarette cravings. The primary aim of this paper is to present the protocol of a study examining the effectiveness of the Physical over smoking app (Ph.o.S) by comparing the point prevalence abstinence rate of a group of users to a comparator group during a 6-month follow-up period. After initial Web-based screening, eligible participants are recruited to attend a smoking cessation program for 3 weeks to set a quit smoking date. Fifty participants who succeed in quitting will be randomly allocated to the comparator and experimental groups. Both groups will separately have 1 more counseling session on how to manage cravings. In this fourth session, the only difference in treatment between the groups is that the experimental group will have an extra 10-15 minutes of guidance on how to use the fully automated Ph.o.S app to manage cravings during the follow-up period. Data will be collected at baseline, as well as before and after the quit day, and follow-up Web-based measures will be collected for a period of 6 months. The primary efficacy outcome is the 7-day point prevalence abstinence rate, and secondary efficacy outcomes are number of relapses and cravings, self-efficacy of being aware of craving experience, self-efficacy in managing cravings, and power of control in managing cravings. Recruitment for this project commenced in December 2014, and proceeded until May 2015. Follow-up data collection has commenced and will be completed by the end of December 2015. If the Ph.o.S app is shown
Sarkar, Bidyut K; Shahab, Lion; Arora, Monika; Lorencatto, Fabiana; Reddy, K Srinath; West, Robert
2014-03-01
India has 275 million adult tobacco users and tobacco use is estimated to contribute to more than a million deaths in the country each year. There is an urgent need to develop and evaluate affordable, practicable and scalable interventions to promote cessation of tobacco use. Because tobacco use is so harmful, an increase of as little as 1 percentage point in long-term quit success rates can have an important public health impact. This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of a brief scalable smoking cessation intervention delivered by trained health professionals as an outreach programme in poor urban communities in India. This is a pragmatic, two-arm, community-based cluster randomized controlled trial focused on tobacco users in low-income communities. The treatment arm is a brief intervention comprising brief advice including training in craving control using simple yogic breathing exercises (BA-YBA) and the control arm is very brief advice (VBA). Of a total of 32 clusters, 16 will be allocated to the intervention arm and 16 to the control arm. Each cluster will have 31 participants, making a total of 992 participants. The primary outcome measure will follow the Russell Standard: self-report of sustained abstinence for at least 6 months following the intervention confirmed at the final follow-up by salivary cotinine. This trial will inform national and international policy on delivery of scalable and affordable brief outreach interventions to promote tobacco use cessation in low resource settings where tobacco users have limited access to physicians and medications. © 2014 Society for the Study of Addiction.
Smits, Jasper A J; Zvolensky, Michael J; Davis, Michelle L; Rosenfield, David; Marcus, Bess H; Church, Timothy S; Powers, Mark B; Frierson, Georita M; Otto, Michael W; Hopkins, Lindsey B; Brown, Richard A; Baird, Scarlett O
2016-04-01
High anxiety sensitivity predicts poor smoking cessation outcomes. Aerobic exercise reduces anxiety sensitivity and aspects of the risk conferred by anxiety sensitivity. In the current study, we examined whether exercise can aid smoking cessation in adults with high anxiety sensitivity. Participants were sedentary and low-activity adult daily smokers (n = 136) with elevated prescreen anxiety sensitivity. Participants received 15 weeks of standard smoking cessation treatment (ST; cognitive behavioral therapy plus nicotine replacement therapy). In addition, participants were simultaneously randomized to 15 weeks of either an exercise intervention (ST + EX; n = 72) or a wellness education control condition (ST + CTRL; n = 64). Self-reported smoking abstinence was assessed weekly during the intervention, at the end of treatment (10 weeks after the target quit date), and at 4 and 6 months after the target quit date. Abstinence was verified by expired carbon monoxide readings and saliva cotinine. Results indicated that point prevalence abstinence (PPA) and prolonged abstinence (PA) rates were significantly higher for ST + EX than for ST + CTRL at each of the major end points among persons with high anxiety sensitivity (PPA: b = -0.91, standard error [SE] = 0.393, t(1171) = -2.33, p = .020; PA: b = -0.98, SE = 0.346, t(132) = -2.84, p = .005), but not among those with low anxiety sensitivity (PPA: b = -0.23, SE = 0.218, t(1171) = -1.06, p = .29; PA: b = -0.31, SE = 0.306, t(132) = -1.01, p = .32). The present results suggest that exercise facilitates the odds of quit success for smokers with high levels of anxiety sensitivity and therefore may be a useful therapeutic tactic for this high-risk segment of the smoking population. ClinicalTrials.gov, NCT01065506.
A Monte Carlo analysis of breast screening randomized trials.
Zamora, Luis I; Forastero, Cristina; Guirado, Damián; Lallena, Antonio M
2016-12-01
To analyze breast screening randomized trials with a Monte Carlo simulation tool. A simulation tool previously developed to simulate breast screening programmes was adapted for that purpose. The history of women participating in the trials was simulated, including a model for survival after local treatment of invasive cancers. Distributions of time gained due to screening detection against symptomatic detection and the overall screening sensitivity were used as inputs. Several randomized controlled trials were simulated. Except for the age range of women involved, all simulations used the same population characteristics and this permitted to analyze their external validity. The relative risks obtained were compared to those quoted for the trials, whose internal validity was addressed by further investigating the reasons of the disagreements observed. The Monte Carlo simulations produce results that are in good agreement with most of the randomized trials analyzed, thus indicating their methodological quality and external validity. A reduction of the breast cancer mortality around 20% appears to be a reasonable value according to the results of the trials that are methodologically correct. Discrepancies observed with Canada I and II trials may be attributed to a low mammography quality and some methodological problems. Kopparberg trial appears to show a low methodological quality. Monte Carlo simulations are a powerful tool to investigate breast screening controlled randomized trials, helping to establish those whose results are reliable enough to be extrapolated to other populations and to design the trial strategies and, eventually, adapting them during their development. Copyright © 2016 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.
DeFulio, Anthony; Silverman, Kenneth
2011-05-01
Due to the chronicity of cocaine dependence, practical and effective maintenance interventions are needed to sustain long-term abstinence. We sought to assess the effects of long-term employment-based reinforcement of cocaine abstinence after discontinuation of the intervention. Participants who initiated sustained opiate and cocaine abstinence during a 6-month abstinence reinforcement and training program worked as data entry operators and were randomly assigned to a group that could work independently of drug use (control, n = 24), or an abstinence-contingent employment (n = 27) group that was required to provide cocaine- and opiate-negative urine samples to work and maintain maximum rate of pay. A non-profit data entry business. Unemployed welfare recipients who persistently used cocaine while in methadone treatment. Urine samples and self-reports were collected every 6 months for 30 months. During the employment year, abstinence-contingent employment participants provided significantly more cocaine-negative samples than controls (82.7% and 54.2%; P = 0.01, OR = 4.61). During the follow-up year, the groups had similar rates of cocaine-negative samples (44.2% and 50.0%; P = 0.93) and human immunodeficiency virus risk behaviors. Participants' social, employment, economic and legal conditions were similar in the two groups across all phases of the study. Employment-based reinforcement effectively maintains long-term cocaine abstinence, but many patients relapse to use when the abstinence contingency is discontinued, even after a year of abstinence-contingent employment. Relapse could be prevented in many patients by leaving employment-based abstinence reinforcement in place indefinitely, which could be facilitated by integrating it into typical workplaces. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.
Lopez, Alexa A; Cobb, Caroline O; Yingst, Jessica M; Veldheer, Susan; Hrabovsky, Shari; Yen, Miao-Shan; Foulds, Jonathan; Eissenberg, Thomas
2016-03-03
This study is a systematic evaluation of a novel tobacco product, electronic cigarettes (ECIGs) using a two-site, four-arm, 6-month, parallel-group randomized controlled trial (RCT) with a follow-up to 9 months. Virginia Commonwealth University is the primary site and Penn State University is the secondary site. This RCT design is important because it is informed by analytical work, clinical laboratory results, and qualitative/quantitative findings regarding the specific ECIG products used. Participants (N = 520) will be randomized across sites and must be healthy smokers of >9 cigarettes for at least one year, who have not had a quit attempt in the prior month, are not planning to quit in the next 6 months, and are interested in reducing cigarette intake. Participants will be randomized into one of four 24-week conditions: a cigarette substitute that does not produce an inhalable aerosol; or one of three ECIG conditions that differ by nicotine concentration 0, 8, or 36 mg/ml. Blocked randomization will be accomplished with a 1:1:1:1 ratio of condition assignments at each site. Specific aims are to: characterize ECIG influence on toxicants, biomarkers, health indicators, and disease risk; determine tobacco abstinence symptom and adverse event profile associated with real-world ECIG use; and examine the influence of ECIG use on conventional tobacco product use. Liquid nicotine concentration-related differences on these study outcomes are predicted. Participants and research staff in contact with participants will be blinded to the nicotine concentration in the ECIG conditions. Results from this study will inform knowledge concerning ECIG use as well as demonstrate a model that may be applied to other novel tobacco products. The model of using prior empirical testing of ECIG devices should be considered in other RCT evaluations. TRN: NCT02342795 , registered December 16, 2014.
Bricker, Jonathan B; Mull, Kristin E; McClure, Jennifer B; Watson, Noreen L; Heffner, Jaimee L
2018-05-01
Millions of people world-wide use websites to help them quit smoking, but effectiveness trials have an average 34% follow-up data retention rate and an average 9% quit rate. We compared the quit rates of a website using a new behavioral approach called Acceptance and Commitment Therapy (ACT; WebQuit.org) with the current standard of the National Cancer Institute's (NCI) Smokefree.gov website. A two-arm stratified double-blind individually randomized trial (n = 1319 for WebQuit; n = 1318 for Smokefree.gov) with 12-month follow-up. United States. Adults (n = 2637) who currently smoked at least five cigarettes per day were recruited from March 2014 to August 2015. At baseline, participants were mean [standard deviation (SD)] age 46.2 years (13.4), 79% women and 73% white. WebQuit.org website (experimental) provided ACT for smoking cessation; Smokefree.gov website (comparison) followed US Clinical Practice Guidelines for smoking cessation. The primary outcome was self-reported 30-day point prevalence abstinence at 12 months. The 12-month follow-up data retention rate was 88% (2309 of 2637). The 30-day point prevalence abstinence rates at the 12-month follow-up were 24% (278 of 1141) for WebQuit.org and 26% (305 of 1168) for Smokefree.gov [odds ratio (OR) = 0.91; 95% confidence interval (CI) = 0.76, 1.10; P = 0.334] in the a priori complete case analysis. Abstinence rates were 21% (278 of 1319) for WebQuit.org and 23% (305 of 1318) for Smokefree.gov (OR = 0.89 (0.74, 1.07; P = 0.200) when missing cases were imputed as smokers. The Bayes factor comparing the primary abstinence outcome was 0.17, indicating 'substantial' evidence of no difference between groups. WebQuit.org and Smokefree.gov had similar 30-day point prevalence abstinence rates at 12 months that were descriptively higher than those of prior published website-delivered interventions and telephone counselor-delivered interventions. © 2017 Society for the Study of Addiction.
2010-01-01
Background Weight gain accompanies smoking cessation, but dieting during quitting is controversial as hunger may increase urges to smoke. This is a feasibility trial for the investigation of a very low calorie diet (VLCD), individual modest energy restriction, and usual advice on hunger, ketosis, urges to smoke, abstinence and weight gain in overweight smokers trying to quit. Methods This is a 3 armed, unblinded, randomized controlled trial in overweight (BMI > 25 kg/m2), daily smokers (CO > 10 ppm); with at least 30 participants in each group. Each group receives identical behavioural support and NRT patches (25 mg(8 weeks),15 mg(2 weeks),10 mg(2 weeks)). The VLCD group receive a 429-559 kcal/day liquid formula beginning 1 week before quitting and continuing for 4 weeks afterwards. The modest energy restricted group (termed individual dietary and activity planning(IDAP)) engage in goal-setting and receive an energy prescription based on individual basal metabolic rate(BMR) aiming for daily reduction of 600 kcal. The control group receive usual dietary advice that accompanies smoking cessation i.e. avoiding feeling hungry but eating healthy snacks. After this, the VLCD participants receive IDAP to provide support for changing eating habits in the longer term; the IDAP group continues receiving this support. The control group receive IDAP 8 weeks after quitting. This allows us to compare IDAP following a successful quit attempt with dieting concurrently during quitting. It also aims to prevent attrition in the unblinded, control group by meeting their need for weight management. Follow-up occurs at 6 and 12 months. Outcome measures include participant acceptability, measured qualitatively by semi-structured interviewing and quantitatively by recruitment and attrition rates. Feasibility of running the trial within primary care is measured by interview and questionnaire of the treatment providers. Adherence to the VLCD is verified by the presence of urinary ketones
Ramo, Danielle E; Kaur, Manpreet; Corpuz, Ella S; Satre, Derek D; Delucchi, Kevin; Brown, Sandra A; Prochaska, Judith J
2018-05-01
Tobacco and alcohol often are used simultaneously by young adults, and their co-use is associated with greater health consequences than from single use. Social media platforms offer low cost and highly accessible channels to reach and engage young people in substance use interventions. The current trial seeks to compare the Facebook Tobacco Status Project (TSP) smoking cessation intervention to an intervention targeting both tobacco use and heavy episodic drinking (TSP + ALC) among young adults who use both substances. This randomized clinical trial will evaluate the feasibility and initial efficacy of TSP + ALC compared to TSP with 225 US young adult smokers reporting heavy drinking. Participants will be recruited online and randomized to one of two conditions (TSP or TSP + ALC), both with assignment to a Facebook group tailored to readiness to quit smoking. Groups will receive a 90-day intervention including daily Facebook postings and weekly live counseling sessions. The TSP + ALC group will include content related to alcohol use. All participants will be offered a 2-week introductory supply of nicotine patch. Participants will complete baseline, 3-, 6-, and 12-month online assessments of substance use and other health risk behaviors. The primary efficacy outcome is biochemically-verified 7-day point prevalence abstinence. Secondary outcomes include alcohol and tobacco use, combined use, and thoughts about each substance. This trial examines an innovative and scalable approach to engaging young adults online in tobacco and alcohol use treatment. Study findings will inform digital health interventions and best practices for treating multiple substance use in young adults. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.
Ramo, Danielle E; Thrul, Johannes; Delucchi, Kevin L; Hall, Sharon; Ling, Pamela M; Belohlavek, Alina; Prochaska, Judith J
2018-05-24
To test the efficacy of the Tobacco Status Project (TSP) Facebook smoking cessation intervention for young adults relative to referral to an on-line program on biochemically verified 7-day abstinence from smoking. Two-group parallel randomized controlled trial, comparing TSP (n = 251) to on-line control (n = 249) with follow-up to 12 months. On-line, throughout the United States. Young adult cigarette smokers (mean age 21 years; 73% white, 55% female, 87% daily smokers). TSP provided private Facebook groups tailored to stage of change to quit smoking, daily contacts, weekly live counseling sessions, and for those ready to quit, six cognitive behavioral therapy counseling sessions. Some TSP groups were assigned randomly to receive a monetary incentive for engagement. Control provided referral to the National Cancer Institute Smokefree.gov website. PRIMARY OUTCOME: Biochemically verified 7-day abstinence over 12 months. Post-treatment (3-month) abstinence; reported abstinence, quit attempt, reduction in smoking, readiness to quit smoking over 12 months. Verified 7-day abstinence was not significantly different for intervention compared with control over 1 year: month 3 (8.3 versus 3.2%), 6 (6.2 versus 6.0%), and 12 (5.9 versus 10.0%); odds ratio (OR) = 1.07; 95% confidence interval (CI) = 0.23, 4.97; retention = 71%. There was an effect at 3 months (OR = 2.52; CI = 1.56, 4.04; P < 0.0001). There were no 12-month treatment effects for reported abstinence (P = 0.746), reduction in smoking by 50% or more (P = 0.533), likelihood of having made a quit attempt (P = 0.387) or stage of change over time (0.968). Participants in TSP engaged more and rated the intervention more favorably than those in the control condition. Compared with referral to a smoking cessation website, a novel USA-focused Facebook smoking cessation intervention did not improve abstinence from smoking over 1 year, but increased abstinence at the end of treatment and was
2012-01-01
Background A hospital admission offers smokers an opportunity to quit. Smoking cessation counseling provided in the hospital is effective, but only if it continues for more than one month after discharge. Providing smoking cessation medication at discharge may add benefit to counseling. A major barrier to translating this research into clinical practice is sustaining treatment during the transition to outpatient care. An evidence-based, practical, cost-effective model that facilitates the continuation of tobacco treatment after discharge is needed. This paper describes the design of a comparative effectiveness trial testing a hospital-initiated intervention against standard care. Methods/design A two-arm randomized controlled trial compares the effectiveness of standard post-discharge care with a multi-component smoking cessation intervention provided for three months after discharge. Current smokers admitted to Massachusetts General Hospital who receive bedside smoking cessation counseling, intend to quit after discharge and are willing to consider smoking cessation medication are eligible. Study participants are recruited following the hospital counseling visit and randomly assigned to receive Standard Care or Extended Care after hospital discharge. Standard Care includes a recommendation for a smoking cessation medication and information about community resources. Extended Care includes up to three months of free FDA-approved smoking cessation medication and five proactive computerized telephone calls that use interactive voice response technology to provide tailored motivational messages, offer additional live telephone counseling calls from a smoking cessation counselor, and facilitate medication refills. Outcomes are assessed at one, three, and six months after hospital discharge. The primary outcomes are self-reported and validated seven-day point prevalence tobacco abstinence at six months. Other outcomes include short-term and sustained smoking cessation
Ward, Kenneth D; Asfar, Taghrid; Al Ali, Radwan; Rastam, Samer; Weg, Mark W Vander; Eissenberg, Thomas; Maziak, Wasim
2013-02-01
Effectiveness of nicotine replacement therapy (NRT) for smoking cessation has not been evaluated in low income countries, such as Syria, where it is expensive and not widely available. We evaluated whether nicotine patch boosts smoking cessation rates when used in conjunction with behavioral support in primary care clinics in Aleppo, Syria. Two arm, parallel group, randomized, placebo controlled, double-blinded multi-site trial. Four primary care clinics in Aleppo, Syria. Two hundred and sixty-nine adult primary care patients received behavioral cessation counseling from a trained primary care physician and were randomized to receive six weeks of treatment with nicotine versus placebo patch. Primary end-points were prolonged abstinence (no smoking after a 2-week grace period) at end of treatment, and 6 and 12 months post-quit day, assessed by self-report and exhaled carbon monoxide levels of <10 p.p.m. Treatment adherence was excellent and nicotine patch produced expected reductions in urges to smoke and withdrawal symptoms, but no treatment effect was observed. The proportion of patients in the nicotine and placebo groups with prolonged abstinence was 21.6% and 20.0%, respectively, at end of treatment, 13.4% and 14.1% at 6 months, and 12.7% and 11.9% at 12 months. Nicotine patches may not be effective in helping smokers in low-income countries to stop when given as an adjunct to behavioural support. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.
Wong, Jean; Abrishami, Amir; Riazi, Sheila; Siddiqui, Naveed; You-Ten, Eric; Korman, Jennifer; Islam, Sazzadul; Chen, Xin; Andrawes, Maged S M; Selby, Peter; Wong, David T; Chung, Frances
2017-08-01
The effectiveness of perioperative interventions to quit smoking with varenicline has not been compared with brief interventions. Our objective was to determine the efficacy of a comprehensive smoking cessation program versus a brief intervention for smoking cessation. In this prospective, multicenter study, 296 patients were randomized to participate in a smoking cessation program (one 10- to 15-minute counseling session, pharmacotherapy with varenicline, an educational pamphlet, and a fax referral to a telephone quitline); or brief advice and self-referral to a telephone quitline. The primary outcome was the 7-day point prevalence (PP) abstinence at 12 months after surgery. Secondary outcomes included abstinence at 1, 3, and 6 months. Multivariable generalized linear regression was used to identify independent variables related to abstinence. The 7-day PP abstinence for the smoking cessation program versus brief advice group was 42.4% vs 26.2% (relative risk [RR], 1.62; 95% confidence interval [CI], 1.16-2.25; P = .003) at 12 months. The 7-day PP abstinence at 1, 3, and 6 months was higher in the smoking cessation group versus the brief advice group: 45.7% vs 25.5% (RR, 1.79; 95% CI, 1.29-2.49; P < .001), 46.4% vs 26.9% (RR, 1.72; 95% CI, 1.25-2.37; P< .001), and 45.0% vs 26.2% (RR, 1.72; 95% CI, 1.24-2.38; P < .001), respectively. Participating in the smoking cessation group predicted abstinence at 12 months (RR, 1.58; 95% CI, 1.12-2.21; P = .0087). A perioperative smoking cessation program with counseling, pharmacotherapy with varenicline, an educational pamphlet, and a fax referral to a quitline increased abstinence from smoking 1, 3, 6, and 12 months after surgery versus a brief intervention.
Morrison, Deborah; Wyke, Sally; Thomson, Neil C; McConnachie, Alex; Agur, Karolina; Saunderson, Kathryn; Chaudhuri, Rekha; Mair, Frances S
2014-05-24
The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of
Bloom, Erika Litvin; Strong, David R.; Riebe, Deborah; Marcus, Bess H.; Desaulniers, Julie; Fokas, Kathryn; Brown, Richard A.
2014-01-01
Introduction: Previous exercise intervention studies for smoking cessation have been challenged by a number of methodological limitations that confound the potential efficacy of aerobic exercise for smoking cessation. Methods: The preliminary efficacy of a behavioral exercise intervention that incorporated features designed to address prior limitations was tested in a randomized controlled trial (RCT). Sixty-one smokers (65.6% female, mean age = 47.3 years, smoked a mean of 19.7 cigarettes/day) were randomized to receive either a 12-week exercise intervention or a 12-week health education contact control. Participants in both conditions received an 8-week telephone-delivered, standard smoking cessation protocol (with the transdermal nicotine patch). Follow-ups were conducted at the end of treatment (EOT), 6- and 12-month timepoints. Results: There were no differences between conditions with respect to the number of weekly exercise or health education sessions attended (9.3±2.8 vs. 9.3±3.0, respectively). While not statistically significant, participants in the exercise condition demonstrated higher verified abstinence rates (EOT: 40% vs. 22.6%, odds ratio [OR] = 2.28; 6- and 12-month follow-ups: 26.7% vs. 12.9%, OR = 2.46). Irrespective of treatment condition, higher levels of moderate-to-vigorous exercise were associated with lower levels of depressive symptoms during the intervention. Conclusions: The results of this small RCT point toward the benefit of a behavioral exercise intervention designed to address previous methodological limitations for smoking cessation. Given the potential public health impact of the demonstrated efficacy of exercise for smoking cessation, the continued development and optimization of exercise interventions for smokers through larger RCTs merits pursuit. PMID:24812023
Gratitude, abstinence, and alcohol use disorders: Report of a preliminary finding.
Krentzman, Amy R
2017-07-01
Gratitude is a central component of addiction recovery for many, yet it has received scant attention in addiction research. In a sample of 67 individuals entering abstinence-based alcohol-use-disorder treatment, this study employed gratitude and abstinence variables from sequential assessments (baseline, 6months, 12months) to model theorized causal relationships: gratitude would increase pre-post treatment and gratitude after treatment would predict greater percent days abstinent 6months later. Neither hypothesis was supported. This unexpected result led to the theory that gratitude for sobriety was the construct of interest; therefore, the association between gratitude and future abstinence would be positive among those already abstinent. Thus, post-treatment abstinence was tested as a moderator of the effect of gratitude on future abstinence: this effect was statistically significant. For those who were abstinent after treatment, the relationship between gratitude and future abstinence was positive; for those drinking most frequently after treatment, the relationship between gratitude and future abstinence was negative. In this preliminary study, dispositional tendency to affirm that there is much to be thankful for appeared to perpetuate the status quo-frequent drinkers with high gratitude were drinking frequently 6months later; abstinent individuals with high gratitude were abstinent 6months later. Gratitude exercises might be contraindicated for clients who are drinking frequently and have abstinence as their treatment goal. Copyright © 2017 Elsevier Inc. All rights reserved.
Hasan, Faysal M; Zagarins, Sofija E; Pischke, Karen M; Saiyed, Shamila; Bettencourt, Ann Marie; Beal, Laura; Macys, Diane; Aurora, Sanjay; McCleary, Nancy
2014-02-01
The efficacy of pharmacotherapy for smoking cessation is well documented. However, due to relapse rates and side effects, hypnotherapy is gaining attention as an alternative treatment option. The aim of this one-center randomized study was to compare the efficacy of hypnotherapy alone, as well as hypnotherapy with nicotine replacement therapy (NRT), to conventional NRT in patients hospitalized with a cardiac or pulmonary illness. We evaluated self-reported and biochemically verified 7-day prevalence smoking abstinence rates at 12 and 26 weeks post-hospitalization. Patients (n=164) were randomized into one of three counseling-based treatment groups: NRT for 30 days (NRT; n=41), a 90-min hypnotherapy session (H; n=39), and NRT with hypnotherapy (HNRT; n=37). Treatment groups were compared to a "self-quit" group of 35 patients who refused intervention. Hypnotherapy patients were more likely than NRT patients to be nonsmokers at 12 weeks (43.9% vs. 28.2%; p=0.14) and 26 weeks after hospitalization (36.6% vs. 18.0%; p=0.06). Smoking abstinence rates in the HNRT group were similar to the H group. There was no difference in smoking abstinence rates at 26 weeks between "self quit" and participants in any of the treatment groups. In multivariable regression analysis adjusting for diagnosis and demographic characteristics, H and HNRT were over three times more likely than NRT participants to abstain at 26-weeks post-discharge (RR=3.6; p=0.03 and RR=3.2; p=0.04, respectively). Hypnotherapy is more effective than NRT in improving smoking abstinence in patients hospitalized for a smoking-related illness, and could be an asset to post-discharge smoking cessation programs. Copyright © 2014 Elsevier Ltd. All rights reserved.
Carroll, Kathleen M; Nich, Charla; Petry, Nancy M; Eagan, Dorothy A; Shi, Julia M; Ball, Samuel A
2016-03-01
This study evaluated the extent to which the addition of disulfiram and contingency management for adherence and abstinence (CM), alone and in combination, might enhance the effects of cognitive behavioral therapy (CBT) for cocaine use disorders. Factorial randomized double blind (for medication condition) clinical trial where CBT served as the platform and was delivered in weekly individual sessions in a community-based outpatient clinic. 99 outpatients who met DSM-IV criteria for current cocaine dependence were assigned to receive either disulfiram or placebo, and either CM or no CM. Cocaine and other substance use was assessed via a daily calendar with thrice weekly urine sample testing for 12 weeks with a one-year follow-up (80% interviewed at one year). The primary hypothesis that CM and disulfiram would produce the best cocaine outcomes was not confirmed, nor was there a main effect for disulfiram. For the primary outcome (percent days of abstinence, self report), there was a significant interaction, with the best cocaine outcomes were seen for the combination of CM and placebo, with the two groups assigned to disulfiram associated with intermediate outcomes, and poorest cocaine outcome among those assigned to placebo and no CM. The secondary outcome (urinalysis) indicated a significant effect favoring CM over no CM but the interaction effect was not significant. One year follow-up data indicated sustained treatment effects across conditions. CM enhances outcomes for CBT treatment of cocaine dependence, but disulfiram provided no added benefit to the combination of CM and CBT. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
Internet-delivered Treatment for Substance Abuse: A Multi-site Randomized Controlled Clinical Trial
Campbell, Aimee N. C.; Nunes, Edward V.; Matthews, Abigail G.; Stitzer, Maxine; Miele, Gloria M.; Polsky, Daniel; Turrigiano, Eva; Walters, Scott; McClure, Erin A.; Kyle, Tiffany L.; Wahle, Aimee; Van Veldhuisen, Paul; Goldman, Bruce; Babcock, Dean; Stabile, Patricia Quinn; Winhusen, Theresa; Ghitza, Udi E.
2014-01-01
Objective Drug and alcohol abuse constitutes a major public health problem. Computer-delivered interventions have potential to improve access to quality care. The objective of this study was to evaluate the effectiveness of the Therapeutic Education System, an internet-delivered behavioral intervention that includes motivational incentives, as a clinician-extender in the treatment of substance use disorders. Method Adult men and women (N=507) entering 10 outpatient addiction treatment programs were randomly assigned to 12-weeks of treatment-as-usual (n=252) or treatment-as-usual + Therapeutic Education System, whereby the intervention substituted for 2 hours of standard care per week (n=255). Therapeutic Education System consists of 62 computer-interactive modules covering skills for achieving and maintaining abstinence, plus prize-based motivational incentives contingent on abstinence and treatment adherence. Treatment-as-usual consisted of individual and group counseling at the participating programs. Primary outcomes were (1) abstinence from drugs and heavy drinking measured by twice weekly urine drug screens and self-report, and (2) time to drop-out from treatment. Results Compared to treatment-as-usual, those receiving Therapeutic Education System reduced dropout from treatment (Hazard Ratio=0.72 [95% CI, 0.57-0.92], P=.010), and increased abstinence (Odds Ratio=1.62 [95% CI: 1.12-2.35], P=.010), an effect that was more pronounced among patients with a positive urine drug and/or breath alcohol screen at the point of study entry (n=228) (Odds Ratio=2.18 [95% CI: 1.30-3.68], P=.003). Conclusion Internet-delivered interventions, such as Therapeutic Education System, have the potential to expand access and improve addiction treatment outcomes; additional research is needed to assess effectiveness in non-specialty clinical systems and to differentiate the effect of Community Reinforcement Approach and Contingency Management. PMID:24700332
2010-01-01
Background It is a priority to achieve smoking cessation in diabetic smokers, given that this is a group of patients with elevated cardiovascular risk. Furthermore, tobacco has a multiplying effect on micro and macro vascular complications. Smoking abstinence rates increase as the intensity of the intervention, length of the intervention and number and diversity of contacts with the healthcare professional during the intervention increases. However, there are few published studies about smoking cessation in diabetics in primary care, a level of healthcare that plays an essential role in these patients. Therefore, the aim of the present study is to evaluate the effectiveness of an intensive smoking cessation intervention in diabetic patients in primary care. Methods/Design Cluster randomized trial, controlled and multicentric. Randomization unit: Primary Care Team. Study population: 546 diabetic smokers older than 14 years of age whose disease is controlled by one of the primary care teams in the study. Outcome Measures: Continuous tobacco abstinence (a person who has not smoked for at least six months and with a CO level of less than 6 ppm measured by a cooximeter) , evolution in the Prochaska and DiClemente's Transtheoretical Model of Change, number of cigarettes/day, length of the visit. Point of assessment: one- year post- inclusion in the study. Intervention: Brief motivational interview for diabetic smokers at the pre-contemplation and contemplation stage, intensive motivational interview with pharmacotherapy for diabetic smokers in the preparation-action stage and reinforcing intevention in the maintenance stage. Statistical Analysis: A descriptive analysis of all variables will be done, as well as a multilevel logistic regression and a Poisson regression. All analyses will be done with an intention to treatment basis and will be fitted for potential confounding factors and variables of clinical importance. Statistical packages: SPSS15, STATA10 y HLM6
Tobacco Cessation via Public Dental Clinics: Results of a Randomized Trial
Andrews, Judy A.; Albert, David A.; Crews, Karen M.; Payne, Thomas J.; Severson, Herbert H.
2010-01-01
Objectives. We sought to compare the effectiveness of a dental practitioner advice and brief counseling intervention to quit tobacco use versus usual care for patients in community health centers on tobacco cessation, reduction in tobacco use, number of quit attempts, and change in readiness to quit. Methods. We randomized 14 federally funded community health center dental clinics that serve diverse racial/ethnic groups in 3 states (Mississippi, New York, and Oregon) to the intervention (brief advice and assistance, including nicotine replacement therapy) or usual care group. Results. We enrolled 2549 smokers. Participants in the intervention group reported significantly higher abstinence rates at the 7.5-month follow-up, for both point prevalence (F1,12 = 6.84; P < .05) and prolonged abstinence (F1,12 = 14.62; P < .01) than did those in the usual care group. Conclusions. The results of our study suggest the viability and effectiveness of tobacco cessation services delivered to low-income smokers via their dental health care practitioner in community health centers. Tobacco cessation services delivered in public dental clinics have the potential to improve the health and well-being of millions of Americans. PMID:20466951
Chan, Sophia S C; Leung, Doris Y P; Wong, David C N; Lau, Chu-Pak; Wong, Vivian T; Lam, Tai-Hing
2012-04-01
To examine the effectiveness of a stage-matched smoking cessation counselling intervention for smokers who had cardiac diseases. A total of 1860 Chinese cardiac patients who smoked at least one cigarette in the past 7 days and aged 18 years or above recruited from cardiac out-patient clinics in Hong Kong hospitals were allocated randomly to an intervention group or control group. The intervention group (n = 938) received counselling matched with their stage of readiness to quit by trained counsellors at baseline, 1 week and 1 month. The control group (n = 922) received brief counselling on healthy diet at baseline. The primary outcomes were self-reported 7-day and 30-day point prevalence (PP) of tobacco abstinence at 12 months after baseline. The secondary outcome measures included biochemically validated abstinence at 12-month follow-up, self-reported 7-day and 30-day PP abstinence and reduction of cigarette consumption by 50% at 3 and 6 months. By intention-to-treat analysis, the intervention and control groups showed no significant difference in self-reported 7-day PP abstinence (intervention: 26.5% versus control: 25.5%; P = 0.60) and 30-day PP (intervention: 25.4% versus control: 24.2%; P = 0.55), biochemically validated abstinence (intervention: 6.6% versus control: 4.9%; P = 0.14) and overall quit attempts of least 24 hours (intervention: 40.3% versus control: 34.3%; P = 0.007) at the 12-month follow-up, adjusted for the baseline stage of readiness to quit smoking. An intervention, based on the Stages of Change model, to promote smoking cessation in cardiac patients in China failed to find any long-term benefit. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.
Martino, Steve; Paris, Manuel; Añez, Luis; Nich, Charla; Canning-Ball, Monica; Hunkele, Karen; Olmstead, Todd A.; Carroll, Kathleen M.
2016-01-01
The effectiveness of a competency-based supervision approach called Motivational Interviewing Assessment: Supervisory Tools for Enhancing Proficiency (MIA: STEP) was compared to Supervision-As-Usual (SAU) for increasing clinicians’ motivational interviewing (MI) adherence and competence and client retention and primary substance abstinence in a multisite Hybrid Type 2 effectiveness-implementation randomized controlled trial. Participants were 66 clinicians and 450 clients within one of eleven outpatient substance abuse programs. An independent evaluation of audio recorded supervision sessions indicated that MIA: STEP and SAU were highly and comparably discriminable across sites. While clinicians in both supervision conditions improved their MI performance, clinician supervised with MIA: STEP, compared to those in SAU, showed significantly greater increases in the competency in which they used fundamental and advanced MI strategies when using MI across seven intakes through a 16-week follow-up. There were no retention or substance use differences among the clients seen by clinicians in MIA: STEP or SAU. MIA: STEP was substantially more expensive to deliver than SAU. Innovative alternatives to resource-intensive competency-based supervision approaches such as MIA: STEP are needed to promote the implementation of evidence-based practices. PMID:27431042
A web application for moderation training: Initial results of a randomized clinical trial1
Hester, Reid K.; Delaney, Harold D.; Campbell, William; Handmaker, Nancy
2009-01-01
Eighty four heavy drinkers who responded to a newspaper recruitment ad were randomly assigned to receive either: a) training in a moderate drinking protocol via an Internet-based program (www.moderatedrinking.com) and use of the online resources of Moderation Management (MM) (www.moderation.org) or b) use of the online resources of MM alone. Follow-ups are being conducted at 3, 6, and 12 months. Results of the recently completed 3 month follow-up (86% follow-up) indicated both groups significantly reduced their drinking based on these variables: standard drinks per week; percent days abstinent; and mean BAC per drinking day. Both groups also significantly reduced their alcohol-related problems. Relative to the control group the experimental group had better outcomes on percent days abstinent and log Drinks per Drinking Day. These short-term outcome data provide evidence for the effectiveness of both the moderate drinking web application and of the resources available online at MM in helping heavy drinkers reduce their drinking and alcohol-related problems. PMID:19339137
Yip, Sarah W; DeVito, Elise E; Kober, Hedy; Worhunsky, Patrick D; Carroll, Kathleen M; Potenza, Marc N
2014-07-01
Cannabis is widely abused, and efficacies of therapeutics for cannabis dependence remain suboptimal. Magnetic resonance imaging (MRI) may aid in the identification of biological markers for successful treatment outcomes (i.e., abstinence). Twenty men with cannabis dependence and twenty non-substance-using healthy comparison (HC) men underwent MRI scanning. Cannabis-dependent individuals then participated in a 12-week randomized clinical trial of behavioral treatments (contingency management (CM), cognitive behavioral therapy (CBT) or both). Pretreatment functional and structural data were compared between the cannabis-dependent and HC participants. In addition, individuals with cannabis dependence were subdivided based on the successful achievement of 21 days of consecutive abstinence during treatment to assess whether abstinent versus non-abstinent cannabis-dependent participants displayed different pretreatment functional and structural characteristics when compared to HC participants. In comparison to HC participants, cannabis-dependent participants demonstrated greater ventral striatal activation during the receipt of losing outcomes and smaller putamenal volumes. Cannabis-dependent participants who did not subsequently achieve 21 days of consecutive abstinence had increased activity within the striatum during the receipt of losing outcomes, relative to HC participants. Cannabis-dependent participants who did not achieve 21 days of abstinence had decreased bilateral putamen volumes prior to treatment, relative to HC participants. Individual differences in pretreatment striatal function and structure may relate to individual differences in treatment responses for cannabis dependence. While mechanisms underlying these associations require further exploration, the striatum might mediate treatment responses via its role in associative reward-learning (e.g., through skills training in CBT or reinforcement of abstinence in CM). Copyright © 2014 Elsevier Ireland Ltd
Perceptions of Massage Therapists Participating in a Randomized Controlled Trial
Perlman, Adam; Dreusicke, Mark; Keever, Teresa; Ali, Ather
2015-01-01
Background Clinical practice and randomized trials often have disparate aims, despite involving similar interventions. Attitudes and expectancies of practitioners influence patient outcomes, and there is growing emphasis on optimizing provider–patient relationships. In this study, we evaluated the experiences of licensed massage therapists involved in a randomized controlled clinical trial using qualitative methodology. Methods Seven massage therapists who were interventionists in a randomized controlled trial participated in structured interviews approximately 30 minutes in length. Interviews focused on their experiences and perceptions regarding aspects of the clinical trial, as well as recommendations for future trials. Transcribed interviews were analyzed for emergent topics and themes using standard qualitative methods. Results Six themes emerged. Therapists discussed 1) promoting the profession of massage therapy through research, 2) mixed views on using standardized protocols, 3) challenges of sham interventions, 4) participant response to the sham intervention, 5) views on scheduling and compensation, and 6) unanticipated benefits of participating in research. Conclusions Therapists largely appreciated the opportunity to promote massage through research. They demonstrated insight and understanding of the rationale for a clinical trial adhering to a standardized protocol. Evaluating the experiences and ideas of complementary and alternative medicine practitioners provides valuable insight that is relevant for the implementation and design of randomized trials. PMID:26388961
ERIC Educational Resources Information Center
Dunn, Kelly E.; Sigmon, Stacey C.; Thomas, Colleen S.; Heil, Sarah H.; Higgins, Stephen T.
2008-01-01
This study evaluated the efficacy of a contingency management (CM) intervention to promote smoking cessation in methadone-maintained patients. Twenty participants, randomized into contingent (n = 10) or noncontingent (n = 10) experimental conditions, completed the 14-day study. Abstinence was determined using breath carbon monoxide and urine…
Silverman, K; Svikis, D; Robles, E; Stitzer, M L; Bigelow, G E
2001-02-01
This study evaluated a novel drug abuse treatment, the Therapeutic Workplace. In this treatment, patients are paid to perform jobs or to participate in job training. Salary is linked to abstinence by requiring patients to provide drug-free urine samples to gain access to the workplace. Pregnant and postpartum drug abuse patients (N = 40) were randomly assigned to a Therapeutic Workplace or usual care control group. Therapeutic Workplace participants were invited to work 3 hr every weekday for 6 months and could earn up to $4,030 in vouchers for abstinence, workplace attendance, and performance. On average, 45% of participants attended the workplace per day. Relative to controls, the Therapeutic Workplace nearly doubled patients' abstinence from opiates and cocaine (33% vs. 59% of thrice-weekly urine samples drug negative, respectively, p < .05). The Therapeutic Workplace can effectively treat heroin and cocaine abuse in pregnant and postpartum women.
Ho, Jen-Yu; Kraemer, William J; Volek, Jeff S; Vingren, Jakob L; Fragala, Maren S; Flanagan, Shawn D; Maladouangdock, Jesse; Szivak, Tunde K; Hatfield, Disa L; Comstock, Brett A; Dunn-Lewis, Courtenay; Ciccolo, Joseph T; Maresh, Carl M
2014-03-01
The purpose of this study was to examine the effects of resistance exercise on the hypothalamic-pituitary-adrenal axis (HPA) response to mental challenge, withdrawal symptoms, urge to smoke, and cognitive stress during 24-hour smoking abstinence. 8 sedentary smokers (mean±SD age: 20.1±1.7y; height: 171.6±10.8cm; body mass: 70.4±12.0kg; smoking history: 2.9±0.8y) completed a 24-hour ad libitum smoking trial (SMO) followed by two 24-hour smoking abstinence trials. During abstinence trials, participants performed six whole body resistance exercises (EX) or a control condition (CON) in the morning, followed by mental challenge tasks in the afternoon. Plasma adrenocorticotropin hormone (ACTH), and salivary and serum cortisol were measured during each visit at rest (REST), and then before (PRE-EX), immediately after (IP-EX), and 30min after exercise (30-EX); and before (PRE-MC), immediately after (IP-MC), and 30min after mental challenge (30-MC). Resistance exercise significantly (p≤0.05) elevated plasma ACTH and serum cortisol at IP-EX during EX compared with SMO and CON trials. Resting ACTH, salivary and serum cortisol concentrations at Pre-MC did not differ between EX and CON trials. The HPA axis response to mental challenge was similar after EX and CON trials. Finally, resistance exercise did not reduce withdrawal symptoms, urge to smoke, or stress. Resistance exercise did not substantially alter resting HPA hormones or the HPA response to mental challenge tasks during 24h of smoking abstinence. © 2013.
Yip, Sarah W.; DeVito, Elise E.; Kober, Hedy; Worhunsky, Patrick D.; Carroll, Kathleen M.; Potenza, Marc N.
2014-01-01
Background Cannabis is widely abused, and efficacies of therapeutics for cannabis dependence remain suboptimal. Magnetic resonance imaging (MRI) may aid in the identification of biological markers for successful treatment outcomes (i.e., abstinence). Methods Twenty men with cannabis dependence and twenty non-substance-using healthy comparison (HC) men underwent MRI scanning. Cannabis-dependent individuals then participated in a 12-week randomized clinical trial of behavioral treatments (contingency management (CM), cognitive behavioral therapy (CBT) or both). Pretreatment functional and structural data were compared between the cannabis-dependent and HC participants. In addition, individuals with cannabis dependence were subdivided based on the successful achievement of 21 days of consecutive abstinence during treatment to assess whether abstinent versus nonabstinent cannabis-dependent participants displayed different pretreatment functional and structural characteristics when compared to HC participants. Results In comparison to HC participants, cannabis-dependent participants demonstrated greater ventral striatal activation during the receipt of losing outcomes and smaller putamenal volumes. Cannabis-dependent participants who did not subsequently achieved 21 days of consecutive abstinence had increased activity within the striatum during the receipt of losing outcomes, relative to HC participants. Cannabis-dependent participants who did not achieve 21 days of abstinence had decreased bilateral putamen volumes prior to treatment, relative to HC participants. Conclusions Individual differences in pretreatment striatal function and structure may relate to individual differences in treatment responses for cannabis dependence. While mechanisms underlying these associations require further exploration, the striatum might mediate treatment responses via its role in associative reward-learning (e.g., through skills training in CBT or reinforcement of abstinence in CM
Hillmer, Ansel T; Kloczynski, Tracy; Sandiego, Christine M; Pittman, Brian; Anderson, Jon M; Labaree, David; Gao, Hong; Huang, Yiyun; Deluliis, Giuseppe; O'Malley, Stephanie S; Carson, Richard E; Cosgrove, Kelly P
2016-04-01
Alcohol dependence and tobacco smoking are highly comorbid, and treating both conditions simultaneously is controversial. Previously, we showed that tobacco smoking interferes with GABAA receptor neuroadaptations during alcohol withdrawal in humans, while this effect did not occur with continued nicotine use during alcohol abstinence in nonhuman primates. Here, we extend our previous work by measuring GABAA receptor availability with positron emission tomography (PET) during drug abstinence in nonhuman primates exposed to alcohol alone, nicotine and alcohol together, and alcohol abstinence with continued nicotine exposure. Twenty-four adolescent male rhesus macaques orally self-administered alcohol and nicotine, available separately in water and saccharin, over 20 weeks. The groups included alcohol alone (n = 8); nicotine and alcohol with simultaneous abstinence (n = 8); nicotine and alcohol with alcohol abstinence while nicotine was still available (n = 8); and a pilot group of animals consuming nicotine alone (n = 6). Animals were imaged with [(11)C]flumazenil PET to measure binding potential (BPND), an index of GABAA receptor availability. Imaging occurred at baseline (drug-naíve), and following alcohol and/or nicotine cessation at 1 day, 8 days, and 12 weeks of abstinence. Generalized linear mixed models were used to examine the time course of [(11)C]flumazenil BPND during alcohol abstinence across groups. Animals consumed 3.95 ± 1.22 g/kg/d alcohol and 55.4 ± 35.1 mg/kg/d nicotine. No significant group effects were observed in [(11)C]flumazenil BPND during alcohol abstinence; however, a main effect of time was detected. Post hoc analyses indicated that all groups abstaining from alcohol exhibited significantly increased GABAA receptor availability at 1 day and 8 days (but not 12 weeks) of abstinence relative to baseline, while no changes in [(11)C]flumazenil BPND during nicotine abstinence alone were observed. These data indicate that neither nicotine nor
Safety of Reiki Therapy for Newborns at Risk for Neonatal Abstinence Syndrome
Wright-Esber, Sandra; Zupancic, Julie; Gargiulo, Deb; Woodall, Patricia
2018-01-01
The incidence of opioid abuse and subsequent drug withdrawal is exponentially on the rise in the United States for many populations including newborns who are born to drug-addicted mothers. These newborns often exhibit symptoms of neonatal abstinence syndrome (NAS) within 24 to 72 hours of birth. Treatment of NAS includes monitoring of withdrawal symptoms, managing physiological parameters, and the use of supportive and pharmacologic treatments. Although a few randomized controlled trials exist, studies on supportive intervention are generally limited by small sample sizes, case study reports, expert opinions, and descriptive design. Few studies address the safety of Reiki for newborns at risk for NAS using neonatal parameters. This pilot study addresses feasibility and demonstrates that Reiki is safe when administered to this high-risk population. Considerations for future studies are discussed. PMID:29315084
Mobile access to virtual randomization for investigator-initiated trials.
Deserno, Thomas M; Keszei, András P
2017-08-01
Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization
Venniro, Marco; Zhang, Michelle; Shaham, Yavin; Caprioli, Daniele
2017-04-01
We recently introduced an animal model of incubation of methamphetamine craving after choice-based voluntary abstinence in male rats. Here we studied the generality of this phenomenon to (1) female rats, and (2) male and female rats with a history of heroin self-administration. We first trained rats to self-administer palatable food pellets for 6 days (6 h per day) for either methamphetamine (0.1 mg/kg/infusion) or heroin (0.1 mg/kg/infusion) for 12 days (6 h/day). We then assessed relapse to drug seeking under extinction conditions after 1 and 21 abstinence days. Between tests, the rats underwent either voluntary abstinence (achieved via a discrete choice procedure between drug and palatable food; 20 trials/day) or home-cage forced abstinence. We found no sex differences in methamphetamine self-administration or in the strong preference for the palatable food over methamphetamine during the choice-based voluntary abstinence. In both sexes, methamphetamine seeking in the relapse tests was higher after 21 days of either voluntary or forced abstinence than after 1 day (incubation of methamphetamine craving). We also found no sex differences in heroin self-administration or the strong preference for the palatable food over heroin during the choice-based voluntary abstinence. However, male and female rats with a history of heroin self-administration showed incubation of heroin craving after forced but not voluntary abstinence. Our results show that incubation of methamphetamine craving after voluntary abstinence generalizes to female rats. Unexpectedly, prolonged voluntary abstinence prevented the emergence of incubation of heroin craving in both sexes.
Hauser, Peter; Fuller, Bret; Ho, Samuel B; Thuras, Paul; Kern, Shira; Dieperink, Eric
2017-07-01
Alcohol use disorders (AUDs) are common among people with chronic hepatitis C (HCV) and accelerate the development of fibrosis and cirrhosis caused by HCV. Baclofen, a gamma-aminobutyric acid (GABA) beta-receptor agonist, differs from medications for AUDs currently approved by the United States Food and Drug Administration (FDA), as it is metabolized primarily through the kidneys. The primary outcome of this study was to compare baclofen with a placebo in the percentage of days abstinent from alcohol. A double-blind, placebo-controlled randomized trial. Hepatology clinics in four separate US Veteran Affairs Medical Centers in the United States. One hundred and eighty Veteran men and women older than 18 years with chronic HCV, a comorbid AUD and current alcohol use. Oral baclofen was given at dosages of 0 (placebo) or 30 mg/day over 12 weeks with concomitant manual-guided counseling. The primary measurement was percentage of days abstinent during the 12-week study period between the baclofen and placebo groups [measured by time-line follow-back (TLFB)]. Secondary measurements were the percentage of Veterans who achieved complete abstinence, the percentage of Veterans who achieved no heavy drinking between weeks 4 and 12 of the study, alcohol craving, anxiety, depression and post-traumatic stress disorder (PTSD). Primary outcome: compared with placebo, baclofen did not improve the percentage of days abstinent. For all subjects there were significant reductions from baseline to 12 weeks in percentage of days abstinent from 37.0% [standard error (SE) = 2.7] to 68.6% (SE = 2.8, F (1151.1) = 66.1, P < 0.001). However, there was no statistically significant difference between groups for change in percentage of days abstinent over the 12-week study period [absolute difference 1.3% (-9.1 to 1.7%), F (1152.6) = 0.005, P = 0.95]. Of subjects who completed the first 4 weeks of the study, 8.9% (15 of 168) achieved complete abstinence; 10.1% (nine of 89) in
Roig, Lydia; Perez, Santiago; Prieto, Gemma; Martin, Carlos; Advani, Mamta; Armengol, Angelina; Roura, Pilar; Manresa, Josep Maria; Briones, Elena
2010-02-04
It is a priority to achieve smoking cessation in diabetic smokers, given that this is a group of patients with elevated cardiovascular risk. Furthermore, tobacco has a multiplying effect on micro and macro vascular complications. Smoking abstinence rates increase as the intensity of the intervention, length of the intervention and number and diversity of contacts with the healthcare professional during the intervention increases. However, there are few published studies about smoking cessation in diabetics in primary care, a level of healthcare that plays an essential role in these patients. Therefore, the aim of the present study is to evaluate the effectiveness of an intensive smoking cessation intervention in diabetic patients in primary care. Cluster randomized trial, controlled and multicentric. Randomization unit: Primary Care Team. 546 diabetic smokers older than 14 years of age whose disease is controlled by one of the primary care teams in the study. Continuous tobacco abstinence (a person who has not smoked for at least six months and with a CO level of less than 6 ppm measured by a cooximeter) , evolution in the Prochaska and DiClemente's Transtheoretical Model of Change, number of cigarettes/day, length of the visit. Point of assessment: one- year post- inclusion in the study. Brief motivational interview for diabetic smokers at the pre-contemplation and contemplation stage, intensive motivational interview with pharmacotherapy for diabetic smokers in the preparation-action stage and reinforcing intevention in the maintenance stage. A descriptive analysis of all variables will be done, as well as a multilevel logistic regression and a Poisson regression. All analyses will be done with an intention to treatment basis and will be fitted for potential confounding factors and variables of clinical importance. Statistical packages: SPSS15, STATA10 y HLM6. The present study will try to describe the profile of a diabetic smoker who receives the most benefit
ERIC Educational Resources Information Center
Jeffries, William L., IV; Dodge, Brian; Bandiera, Frank C.; Reece, Michael
2010-01-01
In the United States, a debate exists as to whether abstinence-only or comprehensive sexuality education strategies are most beneficial for school-age youth. Despite abstinence being a fundamental component of comprehensive education, the two are often characterized as polar opposites. Few studies have examined overlaps between the approaches. The…
Garrison, Kathleen A; Pal, Prasanta; Rojiani, Rahil; Dallery, Jesse; O'Malley, Stephanie S; Brewer, Judson A
2015-04-14
Tobacco use is responsible for the death of about 1 in 10 individuals worldwide. Mindfulness training has shown preliminary efficacy as a behavioral treatment for smoking cessation. Recent advances in mobile health suggest advantages to smartphone-based smoking cessation treatment including smartphone-based mindfulness training. This study evaluates the efficacy of a smartphone app-based mindfulness training program for improving smoking cessation rates at 6-months follow-up. A two-group parallel-randomized clinical trial with allocation concealment will be conducted. Group assignment will be concealed from study researchers through to follow-up. The study will be conducted by smartphone and online. Daily smokers who are interested in quitting smoking and own a smartphone (n = 140) will be recruited through study advertisements posted online. After completion of a baseline survey, participants will be allocated randomly to the control or intervention group. Participants in both groups will receive a 22-day smartphone-based treatment program for smoking. Participants in the intervention group will receive mobile mindfulness training plus experience sampling. Participants in the control group will receive experience sampling-only. The primary outcome measure will be one-week point prevalence abstinence from smoking (at 6-months follow-up) assessed using carbon monoxide breath monitoring, which will be validated through smartphone-based video chat. This is the first intervention study to evaluate smartphone-based delivery of mindfulness training for smoking cessation. Such an intervention may provide treatment in-hand, in real-world contexts, to help individuals quit smoking. Clinicaltrials.gov NCT02134509 . Registered 7 May 2014.
2014-01-01
Background There is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of esophageal cancer, but randomized controlled trials in surgery are often difficult to conduct. The ROMIO (Randomized Open or Minimally Invasive Oesophagectomy) study will establish the feasibility of a main trial which will examine the clinical and cost-effectiveness of minimally invasive and open surgical procedures for the treatment of esophageal cancer. Methods/Design A pilot randomized controlled trial (RCT), in two centers (University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust) will examine numbers of incident and eligible patients who consent to participate in the ROMIO study. Interventions will include esophagectomy by: (1) open gastric mobilization and right thoracotomy, (2) laparoscopic gastric mobilization and right thoracotomy, and (3) totally minimally invasive surgery (in the Bristol center only). The primary outcomes of the feasibility study will be measures of recruitment, successful development of methods to monitor quality of surgery and fidelity to a surgical protocol, and development of a core outcome set to evaluate esophageal cancer surgery. The study will test patient-reported outcomes measures to assess recovery, methods to blind participants, assessments of surgical morbidity, and methods to capture cost and resource use. ROMIO will integrate methods to monitor and improve recruitment using audio recordings of consultations between recruiting surgeons, nurses, and patients to provide feedback for recruiting staff. Discussion The ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for esophageal cancer. Trial registration The pilot trial has Current Controlled Trials registration number ISRCTN59036820(25/02/2013) at http://www.controlled-trials.com; the ROMIO trial record at that site gives a link to the original version of
Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials.
Meropol, Neal J; Wong, Yu-Ning; Albrecht, Terrance; Manne, Sharon; Miller, Suzanne M; Flamm, Anne Lederman; Benson, Al Bowen; Buzaglo, Joanne; Collins, Michael; Egleston, Brian; Fleisher, Linda; Katz, Michael; Kinzy, Tyler G; Liu, Tasnuva M; Margevicius, Seunghee; Miller, Dawn M; Poole, David; Roach, Nancy; Ross, Eric; Schluchter, Mark D
2016-02-10
Lack of knowledge and negative attitudes have been identified as barriers to participation in clinical trials by patients with cancer. We developed Preparatory Education About Clinical Trials (PRE-ACT), a theory-guided, Web-based, interactive computer program, to deliver tailored video educational content to patients in an effort to overcome barriers to considering clinical trials as a treatment option. A prospective, randomized clinical trial compared PRE-ACT with a control condition that provided general clinical trials information produced by the National Cancer Institute (NCI) in text format. One thousand two hundred fifty-five patients with cancer were randomly allocated before their initial visit with an oncologist to PRE-ACT (n = 623) or control (n = 632). PRE-ACT had three main components: assessment of clinical trials knowledge and attitudinal barriers, values assessment with clarification back to patients, and provision of a video library tailored to address each patient's barriers. Outcomes included knowledge and attitudes and preparation for decision making about clinical trials. Both PRE-ACT and control interventions improved knowledge and attitudes (all P < .001) compared with baseline. Patients randomly allocated to PRE-ACT showed a significantly greater increase in knowledge (P < .001) and a significantly greater decrease in attitudinal barriers (P < .001) than did their control (text-only) counterparts. Participants in both arms significantly increased their preparedness to consider clinical trials (P < .001), and there was a trend favoring the PRE-ACT group (P < .09). PRE-ACT was also associated with greater patient satisfaction than was NCI text alone. These data show that patient education before the first oncologist visit improves knowledge, attitudes, and preparation for decision making about clinical trials. Both text and tailored video were effective. The PRE-ACT interactive video program was more effective than NCI text in improving
The Smoking Abstinence Questionnaire: Measurement of smokers’ abstinence-related expectancies
Hendricks, Peter S.; Wood, Sabrina B.; Baker, Majel R.; Delucchi, Kevin L.; Hall, Sharon M.
2011-01-01
AIM To develop and validate a measure of smokers’ expectancies for the abstinence process upon quitting smoking: the Smoking Abstinence Questionnaire (SAQ). DESIGN Principal component analysis and other psychometric analyses of self-report data. SETTING San Francisco, California. PARTICIPANTS 507 adult smokers of at least 10 cigarettes per day diverse in gender, sexual orientation, and ethnoracial status. MEASUREMENTS The primary measure was a draft version of the SAQ. Additional measures assessed a variety of other smoking-related constructs. FINDINGS Principal component analyses revealed 10 factors of the SAQ: Withdrawal, Social Improvement/Nonsmoker Identity, Adverse Outcomes, Treatment Effectiveness, Common Reasons, Barriers to Treatment, Social Support, Optimistic Outcomes, Coffee Use, and Weight Gain. The SAQ factors demonstrated internal consistencies ranging from .62 to .85 and were associated with tobacco dependence, motivation to quit, abstinence self-efficacy, withdrawal symptoms, dietary restraint, shape and weight concern, and tobacco use expectancies. The SAQ predicted smoking-related constructs above and beyond tobacco use expectancies, suggesting that abstinence-related expectancies and tobacco use expectancies are distinct from one another. CONCLUSIONS A newly developed questionnaire, the SAQ, appears to reliably capture smokers’ expectancies for abstinence (Withdrawal, Social Improvement/Nonsmoker Identity, Adverse Outcomes, Common Reasons, Optimistic Outcomes, Coffee Use, and Weight Gain) and expectancies related to the success of a quit attempt (Treatment Effectiveness, Barriers to Treatment, and Social Support). It remains to be seen how far any of these expectancies predict attempts to quit, withdrawal, treatment utilization and response, and quitting success above and beyond existing measures. PMID:21205053
Bujarski, Spencer; Roche, Daniel J O; Sheets, Erin S; Krull, Jennifer L; Guzman, Iris; Ray, Lara A
2015-04-01
Despite the critical role of withdrawal, craving, and positive affect (PA) and negative affect (NA) in smoking relapse, relatively little is known about the temporal and predictive relationship between these constructs within the first day of abstinence. This pilot study aims to characterize dynamic changes in withdrawal, craving, and affect over the course of early abstinence using ecological momentary assessment. Beginning immediately after smoking, moderate and heavy smoking participants (n = 15 per group) responded to hourly surveys assessing craving, withdrawal, NA, and PA. Univariate and multivariate multilevel random coefficient modeling was used to describe the progression of craving, withdrawal/NA, and PA and to test correlations between these constructs at the subject level over the course of early abstinence. Heavy smokers reported greater craving from 1-4 hr of abstinence and greater withdrawal/NA after 3 or more hours as compared with moderate smokers. Level of withdrawal/NA was strongly positively associated with craving, and PA was negatively correlated with craving; however, the temporal dynamics of these correlations differed substantially. The association between withdrawal/NA and craving decreased over early abstinence, whereas the reverse was observed for PA. These findings can inform experimental studies of nicotine abstinence as well as their clinical applications to smoking cessation efforts. In particular, these results help to elucidate the role of PA in nicotine abstinence by demonstrating its independent association with nicotine craving over and above withdrawal/NA. If supported by future studies, these findings can refine experimental methods and clinical approaches for smoking cessation. (c) 2015 APA, all rights reserved).
Unrod, Marina; Simmons, Vani N; Sutton, Steven K; Meltzer, Lauren R; Harrell, Paul T; Meade, Cathy D; Craig, Benjamin M; Lee, Ji-Hyun; Brandon, Thomas H
2014-07-01
Tobacco smoking is the leading preventable cause of mortality and morbidity. Although behavioral counseling combined with pharmacotherapy is the most effective approach to aiding smoking cessation, intensive treatments are rarely chosen by smokers, citing inconvenience. In contrast, minimal self-help interventions have the potential for greater reach, with demonstrated efficacy for relapse prevention, but not for smoking cessation. This paper summarizes the design and methods used for a randomized controlled trial to assess the efficacy of a minimal self-help smoking cessation intervention that consists of a set of booklets delivered across time. Baseline participant recruitment data are also presented. Daily smokers were recruited nationally via multimedia advertisements and randomized to one of three conditions. The Usual Care (UC) group received a standard smoking-cessation booklet. The Standard Repeated Mailings (SRM) group received 8 booklets mailed over a 12-month period. The Intensive Repeated Mailings (IRM) group received 10 booklets and additional supplemental materials mailed monthly over 18months. A total of 2641 smokers were screened, 2349 were randomized, and 1874 provided data for analyses. Primary outcomes will be self-reported abstinence at 6-month intervals up to 30months. If the self-help booklets are efficacious, this minimal, low cost intervention can be widely disseminated and, hence, has the potential for significant public health impact with respect to reduction in smoking-related illness and mortality. Copyright © 2014 Elsevier Inc. All rights reserved.
Goldade, Kate; Whembolua, Guy-Lucien; Thomas, Janet; Eischen, Sara; Guo, Hongfei; Connett, John; Des Jarlais, Don; Resnicow, Ken; Gelberg, Lillian; Owen, Greg; Grant, Jon; Ahluwalia, Jasjit S; Okuyemi, Kolawole S
2011-12-01
Although smoking prevalence remains strikingly high in homeless populations (~70% and three times the US national average), smoking cessation studies usually exclude homeless persons. Novel evidence-based interventions are needed for this high-risk subpopulation of smokers. To describe the aims and design of a first-ever smoking cessation clinical trial in the homeless population. The study was a two-group randomized community-based trial that enrolled participants (n = 430) residing across eight homeless shelters and transitional housing units in Minnesota. The study objective was to test the efficacy of motivational interviewing (MI) for enhancing adherence to nicotine replacement therapy (NRT; nicotine patch) and smoking cessation outcomes. Participants were randomized to one of the two groups: active (8 weeks of NRT + 6 sessions of MI) or control (NRT + standard care). Participants attended six in-person assessment sessions and eight retention visits at a location of their choice over 6 months. Nicotine patch in 2-week doses was administered at four visits over the first 8 weeks of the 26-week trial. The primary outcome was cotinine-verified 7-day point-prevalence abstinence at 6 months. Secondary outcomes included adherence to nicotine patch assessed through direct observation and patch counts. Other outcomes included the mediating and/or moderating effects of comorbid psychiatric and substance abuse disorders. Lessons learned from the community-based cessation randomized trial for improving recruitment and retention in a mobile and vulnerable population included: (1) the importance of engaging the perspectives of shelter leadership by forming and convening a Community Advisory Board; (2) locating the study at the shelters for more visibility and easier access for participants; (3) minimizing exclusion criteria to allow enrollment of participants with stable psychiatric comorbid conditions; (4) delaying the baseline visit from the eligibility visit by a week
Müssener, Ulrika; Bendtsen, Marcus; Karlsson, Nadine; White, Ian R.; McCambridge, Jim; Bendtsen, Preben
2018-01-01
Importance Smoking is globally the most important preventable cause of ill health and death. Mobile telephone interventions and, in particular, short message service (SMS) text messaging, have the potential to overcome access barriers to traditional health services, not least among young people. Objective To determine the effectiveness of a text-based smoking cessation intervention among young people. Design, Setting, and Participants A single-blind, 2-arm, randomized clinical trial (Nicotine Exit [NEXit]) was conducted from October 23, 2014, to April 17, 2015; data analysis was performed from April 23, 2014, to May 22, 2015. Participants included daily or weekly smokers willing to set a quit date within 1 month of enrollment. The study used email to invite all college and university students throughout Sweden to participate. Interventions The NEXit core program is initiated with a 1- to 4-week motivational phase during which participants can choose to set a stop date. The intervention group then received 157 text messages based on components of effective smoking cessation interventions for 12 weeks. The control group received 1 text every 2 weeks thanking them for participating in the study, with delayed access to the intervention. Main Outcomes and Measures The primary outcomes were self-reported prolonged abstinence (not having smoked >5 cigarettes over the past 8 weeks) and 4-week point prevalence of complete smoking cessation shortly after the completion of the intervention (approximately 4 months after the quit date). Results A total of 1590 participants, mainly between 21 and 30 years of age, were randomized into the study; 827 (573 [69.3%] women) were allocated to the intervention group and 763 (522 [68.4%] women) were included in the control group. Primary outcome data were available for 783 (94.7%) of the intervention group and 719 (94.2%) of the control group. At baseline, participants were smoking a median (range) of 63 (1-238) and 70 (2-280) cigarettes
Abrantes, Ana M; Bloom, Erika Litvin; Strong, David R; Riebe, Deborah; Marcus, Bess H; Desaulniers, Julie; Fokas, Kathryn; Brown, Richard A
2014-08-01
Previous exercise intervention studies for smoking cessation have been challenged by a number of methodological limitations that confound the potential efficacy of aerobic exercise for smoking cessation. The preliminary efficacy of a behavioral exercise intervention that incorporated features designed to address prior limitations was tested in a randomized controlled trial (RCT). Sixty-one smokers (65.6% female, mean age = 47.3 years, smoked a mean of 19.7 cigarettes/day) were randomized to receive either a 12-week exercise intervention or a 12-week health education contact control. Participants in both conditions received an 8-week telephone-delivered, standard smoking cessation protocol (with the transdermal nicotine patch). Follow-ups were conducted at the end of treatment (EOT), 6- and 12-month timepoints. There were no differences between conditions with respect to the number of weekly exercise or health education sessions attended (9.3±2.8 vs. 9.3±3.0, respectively). While not statistically significant, participants in the exercise condition demonstrated higher verified abstinence rates (EOT: 40% vs. 22.6%, odds ratio [OR] = 2.28; 6- and 12-month follow-ups: 26.7% vs. 12.9%, OR = 2.46). Irrespective of treatment condition, higher levels of moderate-to-vigorous exercise were associated with lower levels of depressive symptoms during the intervention. The results of this small RCT point toward the benefit of a behavioral exercise intervention designed to address previous methodological limitations for smoking cessation. Given the potential public health impact of the demonstrated efficacy of exercise for smoking cessation, the continued development and optimization of exercise interventions for smokers through larger RCTs merits pursuit. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
Dorey, Enid; Bramley, Dale; Bullen, Chris; Denny, Simon; Elley, C Raina; Maddison, Ralph; McRobbie, Hayden; Parag, Varsha; Rodgers, Anthony; Salmon, Penny
2011-01-01
Background Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones. This social cognitive theory-based intervention (called “STUB IT”) used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques. Objective The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation. Methods A randomized controlled trial was conducted with 6-month follow-up. Participants had to be 16 years of age or over, be current daily smokers, be ready to quit, and have a video message-capable phone. Recruitment targeted younger adults predominantly through radio and online advertising. Registration and data collection were completed online, prompted by text messages. The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date, role model, and timing of messages. Extra messages were available on demand to beat cravings and address lapses. The control group also set a quit date and received a general health video message sent to their phone every 2 weeks. Results The target sample size was not achieved due to difficulty recruiting young adult quitters. Of the 226 randomized participants, 47% (107/226) were female and 24% (54/226) were Maori (indigenous population of New Zealand). Their mean age was 27 years (SD 8.7), and there was a high level of nicotine addiction. Continuous abstinence at 6 months was 26.4% (29/110) in the intervention group and 27.6% (32/116) in the control group (P = .8). Feedback from participants indicated that the support provided by the video role models was important and appreciated. Conclusions This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health
Clark, Vanessa; Baker, Amanda; Lewin, Terry; Richmond, Robyn; Kay-Lambkin, Frances; Filia, Sacha; Castle, David; Williams, Jill; Todd, Juanita
2017-01-01
People living with a psychotic illness have higher rates of cigarette smoking and face unique barriers to quitting compared to the general population. We examined whether self-reported reasons for smoking are useful predictors of successful quit attempts among people with psychosis. As part of a randomized controlled trial addressing smoking and cardiovascular disease risk behaviors among people with psychosis, self-reported reasons for smoking were assessed at baseline (n = 235), 15 weeks (n = 151), and 12 months (n = 139). Three factors from the Reasons for Smoking Questionnaire (Coping, Physiological, and Stimulation/Activation) were entered into a model to predict short- and long-term abstinence. The relationship between these factors and mental health symptoms were also assessed. Participants scoring higher on the Stimulation/Activation factor (control of weight, enjoyment, concentration, and "peps me up") at baseline were just less than half as likely to be abstinent at 15 weeks. Female participants were five times more likely to abstinent at 15 weeks, and those with a higher global functioning at baseline were 5% more likely to be abstinent. There was a positive correlation between changes over time in the Stimulation/Activation factor from baseline to 12-month follow-up and the Brief Psychiatric Rating Scale total score at 12-month follow-up. This indicates that increasingly higher endorsement of the factor was associated with more psychological symptoms. There was also a negative correlation between the change over time in the Stimulation/Activation factor and global functioning at 12 months, indicating that increasingly higher endorsement of the factor led to lower global assessment of functioning. The Stimulation/Activation factor may be particularly important to assess and address among smokers with psychosis. It is recommended that further research use the Reasons for Smoking Questionnaire among smokers with psychosis as a clinical tool to identify
Evaluating the Flipped Classroom: A Randomized Controlled Trial
ERIC Educational Resources Information Center
Wozny, Nathan; Balser, Cary; Ives, Drew
2018-01-01
Despite recent interest in flipped classrooms, rigorous research evaluating their effectiveness is sparse. In this study, the authors implement a randomized controlled trial to evaluate the effect of a flipped classroom technique relative to a traditional lecture in an introductory undergraduate econometrics course. Random assignment enables the…
Design of a cluster-randomized minority recruitment trial: RECRUIT.
Tilley, Barbara C; Mainous, Arch G; Smith, Daniel W; McKee, M Diane; Amorrortu, Rossybelle P; Alvidrez, Jennifer; Diaz, Vanessa; Ford, Marvella E; Fernandez, Maria E; Hauser, Robert A; Singer, Carlos; Landa, Veronica; Trevino, Aron; DeSantis, Stacia M; Zhang, Yefei; Daniels, Elvan; Tabor, Derrick; Vernon, Sally W
2017-06-01
Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or
Subramaniam, Geetha A.; Warden, Diane; Minhajuddin, Abu; Fishman, Marc J.; Stitzer, Maxine L.; Adinoff, Bryon; Trivedi, Madhukar; Weiss, Roger; Potter, Jennifer; Poole, Sabrina A.; Woody, George E.
2013-01-01
Objective To examine predictors of opioid abstinence in buprenorphine/naloxone (Bup/Nal) assisted psychosocial treatment for opioid dependent youth Method Secondary analyses of data from 152 youth (ages 15–21) randomly assigned to 12 weeks of extended Bup/Nal therapy or up to 2 weeks of Bup/Nal detoxification, both with weekly individual and group drug counseling. Logistic regression models were constructed to identify baseline and during-treatment predictors of opioid positive urines (OPU) at week-12. Predictors were selected based on significance or trend toward significance (i.e. p<0.1) and backward stepwise selection was used, controlling for treatment group, to produce final independent predictors at p ≤ 0.05. Results Youth presenting to treatment with past 30-day injection drug use (IDU) and more active medical/psychiatric problems were less likely to have a week-12 OPU. Those with early treatment opioid abstinence (i.e. weeks 1 and 2); and those who received additional non-study treatments during the study were less likely to have a week-12 OPU; and those not completing 12 weeks of treatment were more likely to have an OPU. Conclusions Youth with advanced illness (i.e. reporting IDU and additional health problems), and those receiving ancillary treatments to augment study treatment were more likely to have lower opioid use. Treatment success in the first 2 weeks and completion of 12 weeks of treatment were associated with lower rates of OPU. These findings suggest that youth with advanced illness respond well to Bup/Nal treatment, and identify options for tailoring treatment for opioid-dependent youth presenting at community-based settings. PMID:22024000
Treatment of neonatal abstinence syndrome.
Johnson, K; Gerada, C; Greenough, A
2003-01-01
Neonatal abstinence syndrome (NAS) is suffered by infants withdrawing from substances on which they have become physically dependent after in utero exposure. They may require prolonged treatment and spend weeks or even months in hospital. A wide range of drugs have been used to treat NAS. The efficacy of few, however, have been adequately investigated. Evidence suggests that opioids are the most appropriate, at least in infants exposed to diamorphine or methadone. In all "head to head" trials, diazepam has been shown to be ineffective. Morphine and methadone are currently the most commonly prescribed opioids to treat NAS, but randomised trials have not been undertaken to determine which is the more beneficial. Many infants with NAS have been exposed to multiple substances in utero. Further research is required into whether a single opiate or a multiple drug regimen is the best option for such patients.
Wilson, Kelly L; Smith, Matthew Lee; Menn, Mindy
2013-11-01
The ways in which adolescents define and view sex, abstinence, and virginity impact the efforts of sexuality educators and sexual health professionals. This study examined terminology used by nonsexually active high school students to define abstinence and virginity and identified words students associate with these terms. Purposes included (1) describing words/phrases associated with abstinence; (2) describing phrases for "being abstinent until marriage" and "being a virgin;" (3) assessing concordance between word dyads associated with abstinence; and (4) assessing concordance between phrases defining "abstinent until marriage" and "a virgin." In this study, 216 freshmen provided information about beliefs, behaviors, and perceptions. Pearson chi-square tests and Wilcoxon sign-rank tests assessed sex-based differences, definitions, and levels of concordance were conducted. Girls' friends took an abstinence pledge (p = .004) and their parents (p = .025) and best friends (p < .001) think they should abstain. Male counterparts reported being dissatisfied with current sex status (p = .002) and high acceptance of sex before marriage (p = .011). Boys were more likely to endorse "negative" words than girls. Professionals need to use relevant materials incorporating terminology that resonates with adolescents and programs that engage coherent participant discussions. © 2013, American School Health Association.
Initial abstinence status and contingency management treatment outcomes: does race matter?
Montgomery, LaTrice; Carroll, Kathleen M; Petry, Nancy M
2015-06-01
Limited research has evaluated African American substance users' response to evidence-based treatments. This study examined the efficacy of contingency management (CM) in African American and White cocaine users. A secondary analysis evaluated effects of race, treatment condition, and baseline cocaine urine sample results on treatment outcomes of African American (n = 444) and White (n = 403) cocaine abusers participating in one of six randomized clinical trials comparing CM to standard care. African American and White patients who initiated treatment with a cocaine-negative urine sample remained in treatment for similar durations and submitted a comparable proportion of negative samples during treatment regardless of treatment type; CM was efficacious in both races in terms of engendering longer durations of abstinence in patients who began treatment abstinent. Whites who began treatment with a cocaine positive sample remained in treatment longer and submitted a higher proportion of negative samples when assigned to CM than standard care. African Americans who initiated treatment with a cocaine positive sample, however, did not remain in treatment longer with CM compared with standard care, and gains in terms of drug use outcomes were muted in nature relative to Whites. This interaction effect persisted through the 9-month follow-up period. CM is not equally effective in reducing drug use among all subgroups, specifically African American patients who are using cocaine upon treatment entry. Future research on improving treatment outcomes in this population is needed. (c) 2015 APA, all rights reserved).
An Overview of Randomization and Minimization Programs for Randomized Clinical Trials
Saghaei, Mahmoud
2011-01-01
Randomization is an essential component of sound clinical trials, which prevents selection biases and helps in blinding the allocations. Randomization is a process by which subsequent subjects are enrolled into trial groups only by chance, which essentially eliminates selection biases. A serious consequence of randomization is severe imbalance among the treatment groups with respect to some prognostic factors, which invalidate the trial results or necessitate complex and usually unreliable secondary analysis to eradicate the source of imbalances. Minimization on the other hand tends to allocate in such a way as to minimize the differences among groups, with respect to prognostic factors. Pure minimization is therefore completely deterministic, that is, one can predict the allocation of the next subject by knowing the factor levels of a previously enrolled subject and having the properties of the next subject. To eliminate the predictability of randomization, it is necessary to include some elements of randomness in the minimization algorithms. In this article brief descriptions of randomization and minimization are presented followed by introducing selected randomization and minimization programs. PMID:22606659
Bergen, Andrew W.; Michel, Martha; Nishita, Denise; Krasnow, Ruth; Javitz, Harold S.; Conneely, Karen N.; Lessov-Schlaggar, Christina N.; Hops, Hyman; Zhu, Andy Z. X.; Baurley, James W.; McClure, Jennifer B.; Hall, Sharon M.; Baker, Timothy B.; Conti, David V.; Benowitz, Neal L.; Lerman, Caryn; Tyndale, Rachel F.; Swan, Gary E.
2015-01-01
The Nicotine Metabolite Ratio (NMR, ratio of trans-3’-hydroxycotinine and cotinine), has previously been associated with CYP2A6 activity, response to smoking cessation treatments, and cigarette consumption. We searched for drug metabolizing enzyme and transporter (DMET) gene variation associated with the NMR and prospective abstinence in 2,946 participants of laboratory studies of nicotine metabolism and of clinical trials of smoking cessation therapies. Stage I was a meta-analysis of the association of 507 common single nucleotide polymorphisms (SNPs) at 173 DMET genes with the NMR in 449 participants of two laboratory studies. Nominally significant associations were identified in ten genes after adjustment for intragenic SNPs; CYP2A6 and two CYP2A6 SNPs attained experiment-wide significance adjusted for correlated SNPs (CYP2A6 P ACT=4.1E-7, rs4803381 P ACT=4.5E-5, rs1137115, P ACT=1.2E-3). Stage II was mega-regression analyses of 10 DMET SNPs with pretreatment NMR and prospective abstinence in up to 2,497 participants from eight trials. rs4803381 and rs1137115 SNPs were associated with pretreatment NMR at genome-wide significance. In post-hoc analyses of CYP2A6 SNPs, we observed nominally significant association with: abstinence in one pharmacotherapy arm; cigarette consumption among all trial participants; and lung cancer in four case:control studies. CYP2A6 minor alleles were associated with reduced NMR, CPD, and lung cancer risk. We confirmed the major role that CYP2A6 plays in nicotine metabolism, and made novel findings with respect to genome-wide significance and associations with CPD, abstinence and lung cancer risk. Additional multivariate analyses with patient variables and genetic modeling will improve prediction of nicotine metabolism, disease risk and smoking cessation treatment prognosis. PMID:26132489
Bergen, Andrew W; Michel, Martha; Nishita, Denise; Krasnow, Ruth; Javitz, Harold S; Conneely, Karen N; Lessov-Schlaggar, Christina N; Hops, Hyman; Zhu, Andy Z X; Baurley, James W; McClure, Jennifer B; Hall, Sharon M; Baker, Timothy B; Conti, David V; Benowitz, Neal L; Lerman, Caryn; Tyndale, Rachel F; Swan, Gary E
2015-01-01
The Nicotine Metabolite Ratio (NMR, ratio of trans-3'-hydroxycotinine and cotinine), has previously been associated with CYP2A6 activity, response to smoking cessation treatments, and cigarette consumption. We searched for drug metabolizing enzyme and transporter (DMET) gene variation associated with the NMR and prospective abstinence in 2,946 participants of laboratory studies of nicotine metabolism and of clinical trials of smoking cessation therapies. Stage I was a meta-analysis of the association of 507 common single nucleotide polymorphisms (SNPs) at 173 DMET genes with the NMR in 449 participants of two laboratory studies. Nominally significant associations were identified in ten genes after adjustment for intragenic SNPs; CYP2A6 and two CYP2A6 SNPs attained experiment-wide significance adjusted for correlated SNPs (CYP2A6 PACT=4.1E-7, rs4803381 PACT=4.5E-5, rs1137115, PACT=1.2E-3). Stage II was mega-regression analyses of 10 DMET SNPs with pretreatment NMR and prospective abstinence in up to 2,497 participants from eight trials. rs4803381 and rs1137115 SNPs were associated with pretreatment NMR at genome-wide significance. In post-hoc analyses of CYP2A6 SNPs, we observed nominally significant association with: abstinence in one pharmacotherapy arm; cigarette consumption among all trial participants; and lung cancer in four case:control studies. CYP2A6 minor alleles were associated with reduced NMR, CPD, and lung cancer risk. We confirmed the major role that CYP2A6 plays in nicotine metabolism, and made novel findings with respect to genome-wide significance and associations with CPD, abstinence and lung cancer risk. Additional multivariate analyses with patient variables and genetic modeling will improve prediction of nicotine metabolism, disease risk and smoking cessation treatment prognosis.
Run-Reversal Equilibrium for Clinical Trial Randomization
Grant, William C.
2015-01-01
In this paper, we describe a new restricted randomization method called run-reversal equilibrium (RRE), which is a Nash equilibrium of a game where (1) the clinical trial statistician chooses a sequence of medical treatments, and (2) clinical investigators make treatment predictions. RRE randomization counteracts how each investigator could observe treatment histories in order to forecast upcoming treatments. Computation of a run-reversal equilibrium reflects how the treatment history at a particular site is imperfectly correlated with the treatment imbalance for the overall trial. An attractive feature of RRE randomization is that treatment imbalance follows a random walk at each site, while treatment balance is tightly constrained and regularly restored for the overall trial. Less predictable and therefore more scientifically valid experiments can be facilitated by run-reversal equilibrium for multi-site clinical trials. PMID:26079608
A Framework for Designing Cluster Randomized Trials with Binary Outcomes
ERIC Educational Resources Information Center
Spybrook, Jessaca; Martinez, Andres
2011-01-01
The purpose of this paper is to provide a frame work for approaching a power analysis for a CRT (cluster randomized trial) with a binary outcome. The authors suggest a framework in the context of a simple CRT and then extend it to a blocked design, or a multi-site cluster randomized trial (MSCRT). The framework is based on proportions, an…
Smoking abstinence and reinstatement effects in adolescent cigarette smokers.
Colby, Suzanne M; Leventhal, Adam M; Brazil, Linda; Lewis-Esquerre, Johanna; Stein, L A R; Rohsenow, Damaris J; Monti, Peter M; Niaura, Raymond S
2010-01-01
The study objectives were to examine smoking abstinence and reinstatement effects on subjective experience and cognitive performance among adolescent smokers. Adolescents (aged 14-17 years, 60 daily smokers and 32 nonsmokers) participated. Participants completed baseline assessments (Session 1) and returned to the laboratory 1-3 days later to repeat assessments (Session 2); half of the smokers were randomly assigned to 15-17 hr tobacco abstinence preceding Session 2. During Session 2, abstaining smokers reported significantly greater increases in withdrawal symptoms, smoking urges, and negative affect compared with smokers who did not abstain and compared with nonsmokers. Smoking reinstatement reversed abstinence effects, returning to baseline levels for smoking urges and negative affect. Abstaining smokers showed significantly enhanced cognitive performance on two of six tasks (two-letter search compared with nonabstaining smokers; serial reaction time compared with nonsmokers); smoking reinstatement resulted in significant decrements on these two tasks relative to nonabstaining smokers. Effects of smoking abstinence and reinstatement on self-report measures are consistent with earlier research with adolescent as well as adult smokers and may help to elucidate the motivational underpinnings of smoking maintenance among adolescent smokers. Effects found on cognitive performance were contrary to hypotheses; further research is needed to understand better the role of cognitive performance effects in smoking maintenance among adolescents.
Predictors of Smokeless Tobacco Abstinence
Ebbert, Jon O.; Glover, Elbert; Shinozaki, Eri; Schroeder, Darrell R.; Dale, Lowell C.
2010-01-01
Objectives To investigate predictors of tobacco abstinence among smokeless tobacco (ST) users. Methods Logistic regression analyses assessed characteristics associated with tobacco abstinence among ST users receiving bupropion SR. Results Older age was associated with increased tobacco abstinence in both placebo and bupropion SR groups at end of treatment and one year. Abstinence was lower at one year for subjects with a history of major depression. At end of treatment, a 2-way interaction was detected suggesting bupropion SR may be efficacious for subjects with other household tobacco users. Conclusions Younger ST users and those with a history of depression are less likely to quit ST use. PMID:18442352
A self-determination multiple risk intervention trial to improve smokers' health.
Williams, Geoffrey C; McGregor, Holly; Sharp, Daryl; Kouldes, Ruth W; Lévesque, Chantal S; Ryan, Richard M; Deci, Edward L
2006-12-01
Little is known about how interventions motivate individuals to change multiple health risk behaviors. Self-determination theory (SDT) proposes that patient autonomy is an essential factor for motivating change. An SDT-based intervention to enhance autonomous motivation for tobacco abstinence and improving cholesterol was tested. The Smokers' Health Study is a randomized multiple risk behavior change intervention trial. Smokers were recruited to a tobacco treatment center. A total of 1.006 adult smokers were recruited between 1999 and 2002 from physician offices and by newspaper advertisements. A 6-month clinical intervention (4 contacts) to facilitate internalization of autonomy and perceived competence for tobacco abstinence and reduced percent calories from fat was compared with community care. Clinicians elicited patient perspectives and life strivings, provided absolute coronary artery disease risk estimates,enumerated effective treatment options, supported patient initiatives,minimized clinician control, assessed motivation for change, and developed a plan for change. Twelve-month prolonged tobacco abstinence, and change in percent calories from fat and low-density lipoprotein-cholesterol (LDL-C) from baseline to 18 months. RESULTS- Intention to treat analyses revealed that the intervention significantly increased 12-month prolonged tobacco abstinence (6.2% vs 2.4%; odds ratio [OR]=2.7, P=.01, number needed to treat [NNT] =26), and reduced LDL-C (-8.9 vs -4.1 mg/dL; P=.05). There was no effect on percent calories from fat. An intervention focused on supporting smokers'autonomy was effective in increasing prolonged tobacco abstinence and lowering LDL-C. Clinical interventions for behavior change may be improved by increasing patient autonomy and perceived competence.
Clark, Laura; Ronaldson, Sarah; Dyson, Lisa; Hewitt, Catherine; Torgerson, David; Adamson, Joy
2015-12-01
To assess the effectiveness of sending electronic prompts to randomized controlled trial participants to return study questionnaires. A "trial within a trial" embedded within a study determining the effectiveness of chronic obstructive pulmonary disease (DOC) screening on smoking cessation. Those participants taking part in DOC who provided a mobile phone number and/or an electronic mail address were randomized to either receive an electronic prompt or no electronic prompt to return a study questionnaire. The results were combined with two previous studies in a meta-analysis. A total of 437 participants were randomized: 226 to the electronic prompt group and 211 to the control group. A total of 285 (65.2%) participants returned the follow-up questionnaire: 157 (69.5%) in the electronic prompt group and 128 (60.7%) in the control group [difference 8.8%; 95% confidence interval (CI): -0.11%, 17.7%; P = 0.05]. The mean time to response was 23 days in the electronic prompt group and 33 days in the control group (hazard ratio = 1.27; 95% CI: 1.105, 1.47). The meta-analysis of all three studies showed an increase in response rate of 7.1% (95% CI: 0.8%, 13.3%). The use of electronic prompts increased response rates and reduces the time to response. Copyright © 2015 Elsevier Inc. All rights reserved.
Scott, Mindy E.; Cook, Elizabeth
2016-01-01
Objectives. To evaluate the impacts of an enhanced version of the Family Life and Sexuality Module of the HealthTeacher middle school curriculum. Methods. We conducted a cluster randomized trial of Chicago, Illinois, middle schools. We randomly assigned schools to a treatment group that received the intervention during the 2010–2011 school year or a control group that did not. The primary analysis sample included 595 students (7 schools) in the treatment group and 594 students (7 schools) in the control group. Results. Students in the treatment schools reported greater exposure to information on reproductive health topics such as sexually transmitted infections (STIs; 78% vs 60%; P < .01), abstinence (64% vs 37%; P < .01), and birth control (45% vs 29%; P < .01). They also reported higher average scores on an index of knowledge of contraceptive methods and STI transmission (0.5 vs 0.3; P = .02). We found no statistically significant differences in rates of sexual intercourse (12% vs 12%; P = .99), oral sex (12% vs 9%; P = .18), or other intermediate outcomes. Conclusions. The program had modest effects when tested among Chicago middle school students. PMID:27689479
Abstinence-based programs for prevention of adolescent pregnancies. A review.
Thomas, M H
2000-01-01
This article assesses the abstinence-based programs developed by family life educators and the factors associated with positive results through a review of abstinence promotion programs of the federal government. In 1996, Section 510 was added to Title V of the Social Security Act allocating US$50 million annually from 1998-2000 to fund abstinence education programs, while in 1997, a National Strategy to Prevent Teen Pregnancy was launched by the Office of Adolescent Pregnancy Prevention to provide teen pregnancy programs to at least 25% of the communities. Presented in this paper is a discussion of the Abstinence Only programs, which focus on the prevention of pregnancy and sexually transmitted disease among adolescents, and the Abstinence Plus programs, which emphasize other prevention methods as well as abstinence. Evaluation of Abstinence Only programs include Success Express, Project Taking Charge, Sex Respect, Teen Aid, Values and Choices and Facts and Feelings. Moreover, programs such as Reducing the Risk, Postponing Sexual Involvement, Project Education Now, and Babies Later were evaluated under the Abstinence Plus programs. Several programs evaluated have shown to have a positive effect on attitudes among adolescents, but are not proven to have a significant effect on sexual behavior. In conclusion, this article encourages exploration of new approaches to address teen pregnancy and the increasing incidence of sexually transmitted diseases among adolescents, while the federal government must utilize the implementation of existing programs with positive effects.
Covey, Lirio S.; Hu, Mei-Chen; Winhusen, Theresa; Lima, Jennifer; Berlin, Ivan; Nunes, Edward
2015-01-01
Introduction A preponderance of relevant research has indicated reduction in anxiety and depressive symptoms following smoking abstinence. This secondary analysis investigated whether the phenomenon extends to smokers with attention deficit hyperactivity disorder (ADHD). Methods The study setting was an 11-Week double-blind placebo-controlled randomized trial of osmotic release oral system methylphenidate (OROS-MPH) as a cessation aid when added to nicotine patch and counseling. Participants were 255 adult smokers with ADHD. The study outcomes are: anxiety (Beck Anxiety Inventory (BAI)) and depressed mood (Beck Depression Inventory II (BDI)) measured one Week and six Weeks after a target quit day (TQD). The main predictor is point - prevalence abstinence measured at Weeks 1 and 6 after TQD. Covariates are treatment (OROS-MPH vs placebo), past major depression, past anxiety disorder, number of cigarettes smoked daily, demographics (age, gender, education, marital status) and baseline scores on the BAI, BDI, and the DSM-IV ADHD Rating Scale. Results Abstinence was significantly associated with lower anxiety ratings throughout the post-quit period (p<0.001). Depressed mood was lower for abstainers than non-abstainers at Week 1 (p<0.05), but no longer at Week 6 (p=0.83). Treatment with OROS-MPH relative to placebo showed significant reductions at Week 6 after TQD for both anxiety (p<0.05) and depressed mood (p<0.001), but not at Week 1. Differential abstinence effects of gender were observed. Anxiety and depression ratings at baseline predicted increased ratings of corresponding measures during the post-quit period. Conclusion Stopping smoking yielded reductions in anxiety and depressed mood in smokers with ADHD treated with nicotine patch and counseling. Treatment with OROS-MPH yielded mood reductions in delayed manner. PMID:26272693
Hien, Denise A.; Wells, Elizabeth A.; Jiang, Huiping; Suarez-Morales, Lourdes; Campbell, Aimee N. C.; Cohen, Lisa R.; Miele, Gloria M.; Killeen, Therese; Brigham, Gregory S.; Zhang, Yulei; Hansen, Cheri; Hodgkins, Candace; Hatch-Maillette, Mary; Brown, Chanda; Kulaga, Agatha; Kristman-Valente, Allison; Chu, Melissa; Sage, Robert; Robinson, James A.; Liu, David; Nunes, Edward V.
2009-01-01
We compared the effectiveness of Seeking Safety (SS), an integrated cognitive behavioral treatment for substance use disorder (SUD) and post-traumatic stress disorder (PTSD), to an active comparison health education group (Women’s Health Education [WHE]) within NIDA’s Clinical Trials Network. We randomized 353 women to receive 12 sessions of SS (M = 6.2 sessions) or WHE (M = 6.0 sessions) with follow-up assessment at post-treatment and 3-, 6-, and 12-months post-treatment. Primary outcomes were the Clinician Administered PTSD Scale (CAPS) and PTSD Symptom Scale-Self Report (PSS-SR), and substance use (self-reported abstinence in the prior 7 days and days per week of any substance use). Intention-to-treat analysis showed large, clinically significant reductions in CAPS and PSS-SR symptoms (d = 1.94 and 1.12, respectively), but no reliable difference between conditions. Substance use outcomes were not significantly different over time between the two treatments and at follow-up showed no significant change from baseline, when 46% of participants were abstinent. Study results do not favor SS over WHE as an adjunct to SUD treatment for women with PTSD and reflect considerable opportunity to improve clinical outcomes in community-based treatments for these co-occurring conditions. PMID:19634955
Predictors of Smokeless Tobacco Abstinence
ERIC Educational Resources Information Center
Ebbert, Jon O.; Glover, Elbert D.; Shinozaki, Eri; Schroeder, Darrell R.; Dale, Lowell C.
2008-01-01
Objectives: To investigate predictors of tobacco abstinence among smokeless tobacco (ST) users. Methods: Logistic regression analyses assessed characteristics associated with tobacco abstinence among ST users receiving bupropion SR. Results: Older age was associated with increased tobacco abstinence in both placebo and bupropion SR groups at end…
Lintunen, Taru; Heikkinen, Risto; Vanhala, Mauno; Kettunen, Tarja
2017-01-01
Background While gains in reducing smoking rates in Finland have been made, prevalence rates are still substantial. Relapse rates among smokers engaged in quit-smoking programs are high. Physical activity has been proposed as one means to help smokers manage cravings. Software and apps on mobile phone and handheld devices offer an opportunity to communicate messages on how to use physical activity to manage cravings as part of quit-smoking programs. Objective We aimed to test the feasibility, acceptability, usability, and preliminary efficacy of an mHealth mobile phone app, Physical activity over Smoking (PhoS), to assist smokers in quitting smoking in a randomized controlled trial. The app was designed to prompt smokers to engage in physical activities to manage their smoking cravings. Methods Regular smokers (n=44) attended a group-based behavioral counselling program aimed at promoting physical activity as an additional aid to quit. After quit day, participants were randomly allocated to an intervention (n=25) or to a comparison (n=19) group. Participants in the intervention group were provided with the PhoS app and training on how to use it to assist with relapse prevention. Participants in the comparison condition were provided with generalized relapse prevention training. Results Some participants reported that the PhoS app was useful in assisting them to successfully manage their cigarette cravings, although compliance across the sample was modest and participants reported low levels of usability. Participants receiving the PhoS app did not report greater abstinence than those who did not receive the app. However, participants receiving the app were more likely to report greater abstinence if they did not use pharmacological support, while those who did not receive the app reported greater abstinence when using pharmacological support. Participants receiving the app reported greater levels of physical activity than those who did not. Results revealed that
Bradley, Erin L P; Sales, Jessica M; Murray, Colleen C; DiClemente, Ralph J
2012-12-01
Sexually active African American females are at increased risk for acquiring HIV or STIs. However, some reduce their risk by abstaining from sex for various periods of time following initiation, a practice known as secondary abstinence. Although this may be a valuable mechanism for reducing HIV or STI rates in this population, little is known about those interested in secondary abstinence. Baseline data were obtained from a sample of African American adolescent females, ages 14-20 years, prior to participation in an HIV-risk reduction intervention trial (N = 701). Differences in individual-level and interpersonal-level factors, as well as sociodemographic variables were examined between participants who reported strong interest in secondary abstinence and those who did not. 144 (20.5%) participants reported strong interest in secondary abstinence. Young women with strong interest in abstinence had higher odds of reporting a history of STIs and feeling negative emotions following sex because of their religious beliefs. They also had higher odds of believing their partner may be interested in abstaining and being less invested in their relationship with their main partner. Additionally, adolescents reported less interpersonal stress and more social support. African American females who are interested in practicing secondary abstinence and those who are not differ in their sexual health education needs. Findings from this study characterizing young women interested in secondary abstinence can help researchers provide more targeted health education by identifying those who may be more responsive to abstinence-promoting messages.
Müssener, Ulrika; Bendtsen, Marcus; Karlsson, Nadine; White, Ian R; McCambridge, Jim; Bendtsen, Preben
2016-03-01
Smoking is globally the most important preventable cause of ill health and death. Mobile telephone interventions and, in particular, short message service (SMS) text messaging, have the potential to overcome access barriers to traditional health services, not least among young people. To determine the effectiveness of a text-based smoking cessation intervention among young people. A single-blind, 2-arm, randomized clinical trial (Nicotine Exit [NEXit]) was conducted from October 23, 2014, to April 17, 2015; data analysis was performed from April 23, 2014, to May 22, 2015. Participants included daily or weekly smokers willing to set a quit date within 1 month of enrollment. The study used email to invite all college and university students throughout Sweden to participate. The NEXit core program is initiated with a 1- to 4-week motivational phase during which participants can choose to set a stop date. The intervention group then received 157 text messages based on components of effective smoking cessation interventions for 12 weeks. The control group received 1 text every 2 weeks thanking them for participating in the study, with delayed access to the intervention. The primary outcomes were self-reported prolonged abstinence (not having smoked >5 cigarettes over the past 8 weeks) and 4-week point prevalence of complete smoking cessation shortly after the completion of the intervention (approximately 4 months after the quit date). A total of 1590 participants, mainly between 21 and 30 years of age, were randomized into the study; 827 (573 [69.3%] women) were allocated to the intervention group and 763 (522 [68.4%] women) were included in the control group. Primary outcome data were available for 783 (94.7%) of the intervention group and 719 (94.2%) of the control group. At baseline, participants were smoking a median (range) of 63 (1-238) and 70 (2-280) cigarettes per week, respectively. Eight-week prolonged abstinence was reported by 203 participants (25.9%) in the
Long-term abstinent alcoholics have normal memory.
Reed, R J; Grant, I; Rourke, S B
1992-08-01
It is generally believed that many non-Korsakoff alcoholics have subtle defects in memory. To determine whether such defects vary as a function of length of abstinence (LOA), we performed extensive memory testing with: (1) recently detoxified (n = 31; LOA-29 days); (2) intermediate-term abstinent (n = 28; LOA = 1.9 years); (3) long-term abstinent (n = 32; LOA-7.0 years) alcoholics; and (4) nonalcoholic controls (n = 37). All subjects were matched on age and education. Alcoholics were matched on years of alcoholic drinking. Memory measures were divided into the following domains: verbal learning, verbal recall, visual learning, visual recall, and paired associate learning. A series of MANOVAs were conducted that revealed a significant relationship between visual learning and length of abstinence, and a significant interaction between age and length of abstinence on visual recall. Long-term abstinent subjects were not significantly different from controls on any test. We conclude that memory disturbance demonstrable among recently detoxified alcoholics in the early weeks of their abstinence is not evident in demographically matched long-term abstinent alcoholics with similar drinking histories.
Llewellyn-Bennett, Rebecca; Bowman, Louise; Bulbulia, Richard
2016-12-15
Clinical trials typically have a relatively short follow-up period, and may both underestimate potential benefits of treatments investigated, and fail to detect hazards, which can take much longer to emerge. Prolonged follow-up of trial participants after the end of the scheduled trial period can provide important information on both efficacy and safety outcomes. This protocol describes a systematic review to qualitatively compare methods of post-trial follow-up used in large randomized controlled trials. A systematic search of electronic databases and clinical trial registries will use a predefined search strategy. All large (more than 1000 adult participants) randomized controlled trials will be evaluated. Two reviewers will screen and extract data according to this protocol with the aim of 95% concordance of papers checked and discrepancies will be resolved by a third reviewer. Trial methods, participant retention rates and prevalence of missing data will be recorded and compared. The potential for bias will be evaluated using the Cochrane Risk of Bias tool (applied to the methods used during the in-trial period) with the aim of investigating whether the quality of the post-trial follow-up methodology might be predicted by the quality of the methods used for the original trial. Post-trial follow-up can provide valuable information about the long-term benefits and hazards of medical interventions. However, it can be logistically challenging and costly. The aim of this systematic review is to describe how trial participants have been followed-up post-trial in order to inform future post-trial follow-up designs. Not applicable for PROSPERO registration.
Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available.
Hernán, Miguel A; Robins, James M
2016-04-15
Ideally, questions about comparative effectiveness or safety would be answered using an appropriately designed and conducted randomized experiment. When we cannot conduct a randomized experiment, we analyze observational data. Causal inference from large observational databases (big data) can be viewed as an attempt to emulate a randomized experiment-the target experiment or target trial-that would answer the question of interest. When the goal is to guide decisions among several strategies, causal analyses of observational data need to be evaluated with respect to how well they emulate a particular target trial. We outline a framework for comparative effectiveness research using big data that makes the target trial explicit. This framework channels counterfactual theory for comparing the effects of sustained treatment strategies, organizes analytic approaches, provides a structured process for the criticism of observational studies, and helps avoid common methodologic pitfalls. © The Author 2016. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial
2016-03-01
AWARD NUMBER: W81XWH-11-2-0123 TITLE: Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial PRINCIPAL INVESTIGATOR: Dr...Caring Letters for Military Suicide Prevention: A Randomized 5a. CONTRACT NUMBER Controlled Trial 5b. GRANT NUMBER W81XWH-11-2-0123 5c. PROGRAM...determine if the intervention is effective in preventing suicide and suicidal behaviors among Service Members and Veterans. The “caring letters
Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial
2017-03-01
AWARD NUMBER: W81XWH-11-2-0123 TITLE: Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial PRINCIPAL INVESTIGATOR: Dr...Caring Letters for Military Suicide Prevention: A Randomized 5a. CONTRACT NUMBER Controlled Trial 5b. GRANT NUMBER W81XWH-11-2-0123 5c. PROGRAM...determine if the intervention is effective in preventing suicide and suicidal behaviors among Service Members and Veterans. The “caring letters” concept
Horne, B D; Muhlestein, J B; Lappé, D L; May, H T; Carlquist, J F; Galenko, O; Brunisholz, K D; Anderson, J L
2013-11-01
Routine, periodic fasting is associated with a lower prevalence of coronary artery disease (CAD). Animal studies show that fasting may increase longevity and alter biological parameters related to longevity. We evaluated whether fasting initiates acute changes in biomarker expression in humans that may impact short- and long-term health. Apparently-healthy volunteers (N = 30) without a recent history of fasting were enrolled in a randomized cross-over trial. A one-day water-only fast was the intervention and changes in biomarkers were the study endpoints. Bonferroni correction required p ≤ 0.00167 for significance (p < 0.05 was a trend that was only suggestively significant). The one-day fasting intervention acutely increased human growth hormone (p = 1.1 × 10⁻⁴), hemoglobin (p = 4.8 × 10⁻⁷), red blood cell count (p = 2.5 × 10⁻⁶), hematocrit (p = 3.0 × 10⁻⁶), total cholesterol (p = 5.8 × 10⁻⁵), and high-density lipoprotein cholesterol (p = 0.0015), and decreased triglycerides (p = 1.3 × 10⁻⁴), bicarbonate (p = 3.9 × 10⁻⁴), and weight (p = 1.0 × 10⁻⁷), compared to a day of usual eating. For those randomized to fast the first day (n = 16), most factors including human growth hormone and cholesterol returned to baseline after the full 48 h, with the exception of weight (p = 2.5 × 10⁻⁴) and (suggestively significant) triglycerides (p = 0.028). Fasting induced acute changes in biomarkers of metabolic, cardiovascular, and general health. The long-term consequences of these short-term changes are unknown but repeated episodes of periodic short-term fasting should be evaluated as a preventive treatment with the potential to reduce metabolic disease risk. Clinical trial registration (ClinicalTrials.gov): NCT01059760 (Expression of Longevity Genes in Response to Extended Fasting [The Fasting and Expression of Longevity Genes during Food abstinence {FEELGOOD} Trial]). Copyright © 2012 Elsevier B.V. All rights reserved.
Keller, Marla J; Mesquita, Pedro M; Marzinke, Mark A; Teller, Ryan; Espinoza, Lilia; Atrio, Jessica M; Lo, Yungtai; Frank, Bruce; Srinivasan, Sujatha; Fredricks, David N; Rabe, Lorna; Anderson, Peter L; Hendrix, Craig W; Kiser, Patrick F; Herold, Betsy C
2016-03-13
Tenofovir disoproxil fumarate (TDF), a prodrug of tenofovir (TFV), may be ideal for topical HIV preexposure prophylaxis because it has higher tissue and cell permeability than TFV; is not adversely impacted by seminal proteins; and its active metabolite, TFV-diphosphate (TFV-DP), has a long intracellular half-life. We engineered a TDF eluting polyurethane reservoir intravaginal ring (IVR) to provide near constant mucosal antiretroviral concentrations. A first-in-human randomized placebo-controlled trial was conducted to assess the safety and pharmacokinetics of the TDF IVR in healthy, sexually abstinent women (15 TDF and 15 placebo). Drug concentrations were measured in cervicovaginal fluid (CVF) obtained by swab, cervical tissue, plasma, and dried blood spots (DBS) over 14 days of continuous ring use. There were 43 total, 23 reproductive tract, and eight product-related grade 1 adverse events. Steady-state CVF TFV concentrations were achieved proximal (vagina, ectocervix) and distal (introitus) to the TDF IVR 1 day after ring insertion. Median tissue TFV-DP concentrations 14 days after TDF IVR placement were 120 fmol/mg (interquartile range 90, 550). CVF collected from the cervix 1 week and 2 weeks after TDF IVR insertion provided significant protection against ex-vivo HIV challenge. Eleven of 14 (78%) participants had detectable TFV-DP DBS concentrations 14 days after TDF IVR placement, suggesting that DBS may provide a surrogate marker of adherence in future clinical trials. A TDF IVR is safe, well tolerated, and results in mucosal TFV concentrations that exceed those associated with HIV protection. The findings support further clinical evaluation of this TDF IVR.
DeVito, Elise E; Kiluk, Brian D; Nich, Charla; Mouratidis, Maria; Carroll, Kathleen M
2018-02-01
Poor performance on Drug Stroop tasks, which could indicate attentional bias to drug-related cues, craving, poor cognitive control (including poor response inhibition), has been associated with substance use severity, treatment retention and substance use treatment outcomes. Cognitive Behavioral Therapy (CBT) focuses on training in appraisal and coping strategies, including strategies to minimize the negative impact of triggers and coping with drug-cue-induced craving. One mechanism of action of CBT may be the strengthening of cognitive control processes and reduction of attentional bias to drug-related stimuli. Methadone-maintained individuals with cocaine-use disorders, participating in a randomized controlled trial of treatment as usual (TAU) versus TAU plus access to computer-based CBT (CBT4CBT), completed a computerized Drug Stroop task at pre- and post-treatment. Analyses determined whether attentional bias toward drug-related stimuli changed differentially by treatment group or cocaine use outcomes across the treatment period and whether engagement in components of CBT4CBT or TAU treatment related to changes in attentional bias toward drug-related stimuli at post- versus pre-treatment. Participants achieving a longer duration of cocaine abstinence during treatment (3+ weeks) showed greater reductions in Drug Stroop Effect than those with shorter maximum continuous abstinence. Reductions in Drug Stroop Effect across treatment were associated with greater engagement with CBT4CBT-specific treatment components, but not TAU-specific treatment components. Reduction in attentional bias to drug-related cues and craving and/or improved executive cognitive control and response inhibition may contribute to the mechanism of action of CBT4CBT. Copyright © 2017 Elsevier B.V. All rights reserved.
Acupuncture for alcohol withdrawal: a randomized controlled trial.
Trümpler, François; Oez, Suzan; Stähli, Peter; Brenner, Hans Dieter; Jüni, Peter
2003-01-01
Previous trials on acupuncture in alcohol addiction were in outpatients and focused on relapse prevention. Rates of dropout were high and interpretation of results difficult. We compared auricular laser and needle acupuncture with sham laser stimulation in reducing the duration of alcohol withdrawal. Inpatients undergoing alcohol withdrawal were randomly allocated to laser acupuncture (n = 17), needle acupuncture (n = 15) or sham laser stimulation (n = 16). Attempts were made to blind patients, therapists and outcome assessors, but this was not feasible for needle acupuncture. The duration of withdrawal symptoms (as assessed using a nurse-rated scale) was the primary outcome; the duration of sedative prescription was the secondary outcome. Patients randomized to laser and sham laser had identical withdrawal symptom durations (median 4 days). Patients randomized to needle stimulation had a shorter duration of withdrawal symptoms (median 3 days; P = 0.019 versus sham intervention), and tended to have a shorter duration of sedative use, but these differences diminished after adjustment for baseline differences. The data from this pilot trial do not suggest a relevant benefit of auricular laser acupuncture for alcohol withdrawal. A larger trial including adequate sham interventions is needed, however, to reliably determine the effectiveness of any type of auricular acupuncture in this condition.
Smoking abstinence and reinstatement effects in adolescent cigarette smokers
Leventhal, Adam M.; Brazil, Linda; Lewis-Esquerre, Johanna; Stein, L. A. R.; Rohsenow, Damaris J.; Monti, Peter M.; Niaura, Raymond S.
2010-01-01
Introduction The study objectives were to examine smoking abstinence and reinstatement effects on subjective experience and cognitive performance among adolescent smokers. Methods Adolescents (aged 14–17 years, 60 daily smokers and 32 nonsmokers) participated. Participants completed baseline assessments (Session 1) and returned to the laboratory 1–3 days later to repeat assessments (Session 2); half of the smokers were randomly assigned to 15–17 hr tobacco abstinence preceding Session 2. Results During Session 2, abstaining smokers reported significantly greater increases in withdrawal symptoms, smoking urges, and negative affect compared with smokers who did not abstain and compared with nonsmokers. Smoking reinstatement reversed abstinence effects, returning to baseline levels for smoking urges and negative affect. Abstaining smokers showed significantly enhanced cognitive performance on two of six tasks (two-letter search compared with nonabstaining smokers; serial reaction time compared with nonsmokers); smoking reinstatement resulted in significant decrements on these two tasks relative to nonabstaining smokers. Discussion Effects of smoking abstinence and reinstatement on self-report measures are consistent with earlier research with adolescent as well as adult smokers and may help to elucidate the motivational underpinnings of smoking maintenance among adolescent smokers. Effects found on cognitive performance were contrary to hypotheses; further research is needed to understand better the role of cognitive performance effects in smoking maintenance among adolescents. PMID:19933776
Okuyemi, Kolawole S; James, Aimee S; Mayo, Matthew S; Nollen, Nicole; Catley, Delwyn; Choi, Won S; Ahluwalia, Jasjit S
2007-02-01
Despite high smoking rates among those living in poverty, few cessation studies are conducted in these populations. This cluster-randomized trial tested nicotine gum plus motivational interviewing (MI) for smoking cessation in 20 low-income housing developments (HDs). Intervention participants (10 HDs, n = 66) received educational materials, 8 weeks of 4 mg nicotine gum, and 5 MI sessions on quitting smoking. Comparison participants (10 HDs, n = 107) received 5 MI sessions and educational materials addressing fruit and vegetable consumption. Participants had a mean age of 46.3 years and were predominantly female (70%) and African American (83%). Biochemically-verified 7-day abstinence rates at 8 weeks were 6.1% and 5.6% in the intervention and comparison arms, respectively (p = ns); and at 26 weeks were 7.6% and 9.3%, respectively (p = ns). Results suggest that nicotine gum plus MI were not effective for smoking cessation in low-income housing. Programs are needed to enhance the effectiveness of pharmacotherapy and counseling in underserved populations.
Prospective, randomized, controlled trial using best-selling smoking-cessation book.
Foshee, James P; Oh, Anita; Luginbuhl, Adam; Curry, Joseph; Keane, William; Cognetti, David
2017-07-01
Our prospective, randomized, controlled trial aimed to evaluate the efficacy of the self-help book, The Easy Way to Stop Smoking, by Allen Carr, in promoting smoking cessation in patients with head and neck cancer. We assessed active smokers for their willingness to read a smoking cessation book. Participants were randomized to either receive the book from our department or recommended to purchase the book. All patients received smoking cessation counseling at recruitment. Phone surveys were conducted at short- and long-term intervals to determine if the patients had purchased and/or read the book and whether they were still smoking. One hundred twelve patients were recruited, 52 of whom completed follow-up surveys. Those who received the book for free were more likely to read the book (p = 0.05). Reading the book did not correlate with successful smoking cessation (p = 0.81). Some 26% of the 27 patients who received the book quit smoking compared with 32% of the 25 patients who were recommended the book (p = 0.76). Patients who indicated motivation to quit smoking were more likely to succeed. In our study, smoking cessation did not appear to be influenced by reading The Easy Way to Stop Smoking. Despite 80.8% of the cohort indicating at least a readiness to quit smoking at recruitment, only 28.8% of patients managed to achieve successful smoking cessation at long-term follow-up. Patient motivation remains an important factor in achieving long-term smoking abstinence. Quitting smoking remains a daunting challenge for patients, with multiple interventions likely needed to achieve cessation.
A Self-Determination Multiple Risk Intervention Trial to Improve Smokers' Health
Williams, Geoffrey C; McGregor, Holly; Sharp, Daryl; Kouides, Ruth W; Lévesque, Chantal S; Ryan, Richard M; Deci, Edward L
2006-01-01
BACKGROUND Little is known about how interventions motivate individuals to change multiple health risk behaviors. Self-determination theory (SDT) proposes that patient autonomy is an essential factor for motivating change. OBJECTIVE An SDT-based intervention to enhance autonomous motivation for tobacco abstinence and improving cholesterol was tested. DESIGN The Smokers' Health Study is a randomized multiple risk behavior change intervention trial. SETTING Smokers were recruited to a tobacco treatment center. PATIENTS A total of 1,006 adult smokers were recruited between 1999 and 2002 from physician offices and by newspaper advertisements. INTERVENTIONS A 6-month clinical intervention (4 contacts) to facilitate internalization of autonomy and perceived competence for tobacco abstinence and reduced percent calories from fat was compared with community care. Clinicians elicited patient perspectives and life strivings, provided absolute coronary artery disease risk estimates, enumerated effective treatment options, supported patient initiatives, minimized clinician control, assessed motivation for change, and developed a plan for change. MAIN OUTCOME MEASURES Twelve-month prolonged tobacco abstinence, and change in percent calories from fat and low-density lipoprotein-cholesterol (LDL-C) from baseline to 18 months. RESULTS Intention to treat analyses revealed that the intervention significantly increased 12-month prolonged tobacco abstinence (6.2% vs 2.4%; odds ratio [OR]=2.7, P=.01, number needed to treat [NNT]=26), and reduced LDL-C (−8.9 vs −4.1 mg/dL; P=.05). There was no effect on percent calories from fat. CONCLUSIONS An intervention focused on supporting smokers' autonomy was effective in increasing prolonged tobacco abstinence and lowering LDL-C. Clinical interventions for behavior change may be improved by increasing patient autonomy and perceived competence. PMID:16995893
McDonell, Michael G.; Leickly, Emily; McPherson, Sterling; Skalisky, Jordan; Srebnik, Debra; Angelo, Frank; Vilardaga, Roger; Nepom, Jenny R.; Roll, John M.; Ries, Richard K.
2017-01-01
Objective To determine if a contingency management intervention using the ethyl glucuronide (EtG) alcohol biomarker resulted in increased alcohol abstinence in outpatients with co-occurring serious mental illnesses. Secondary objectives were to determine if contingency management was associated with changes in heavy drinking, treatment attendance, drug use, cigarette smoking, psychiatric symptoms, and HIV-risk behavior. Method Seventy-nine (37% female, 44% non-white) outpatients with serious mental illness and alcohol dependence receiving treatment as usual completed a 4-week observation period and were randomized to 12-weeks of contingency management for EtG-negative urine samples and addiction treatment attendance, or reinforcement only for study participation. Contingency management included the variable magnitude of reinforcement “prize draw” procedure contingent on EtG-negative samples (<150 ng/mL) three times a week and weekly gift cards for outpatient treatment attendance. Urine EtG, drug test, and self-report outcomes were assessed during the 12-week intervention and 3-month follow-up periods. Results Contingency management participants were 3.1 times (95% CI: 2.2, 4.5) more likely to submit an EtG-negative urine test during the 12-week intervention period, attaining nearly 1.5 weeks of additional abstinence relative to controls. Contingency management participants had significantly lower mean EtG levels, reported less drinking and fewer heavy drinking episodes, and were more likely to submit stimulant-negative urine and smoking-negative breath samples, relative to controls. Differences in self-reported alcohol use were maintained at the 3-month follow-up. Conclusions This is the first randomized trial utilizing an accurate and validated biomarker (EtG) to demonstrate the efficacy of contingency management for alcohol dependence in outpatients with serious mental illness. PMID:28135843
McDonell, Michael G; Leickly, Emily; McPherson, Sterling; Skalisky, Jordan; Srebnik, Debra; Angelo, Frank; Vilardaga, Roger; Nepom, Jenny R; Roll, John M; Ries, Richard K
2017-04-01
The authors examined whether a contingency management intervention using the ethyl glucuronide (EtG) alcohol biomarker resulted in increased alcohol abstinence in outpatients with co-occurring serious mental illnesses. Secondary objectives were to determine whether contingency management was associated with changes in heavy drinking, treatment attendance, drug use, cigarette smoking, psychiatric symptoms, and HIV-risk behavior. Seventy-nine (37% female, 44% nonwhite) outpatients with serious mental illness and alcohol dependence receiving treatment as usual completed a 4-week observation period and were randomly assigned to 12 weeks of contingency management for EtG-negative urine samples and addiction treatment attendance, or reinforcement only for study participation. Contingency management included the variable magnitude of reinforcement "prize draw" procedure contingent on EtG-negative samples (<150 ng/mL) three times a week and weekly gift cards for outpatient treatment attendance. Urine EtG, drug test, and self-report outcomes were assessed during the 12-week intervention and 3-month follow-up periods. Contingency management participants were 3.1 times (95% CI=2.2-4.5) more likely to submit an EtG-negative urine test during the 12-week intervention period, attaining nearly 1.5 weeks of additional alcohol abstinence compared with controls. Contingency management participants had significantly lower mean EtG levels, reported less drinking and fewer heavy drinking episodes, and were more likely to submit stimulant-negative urine and smoking-negative breath samples, compared with controls. Differences in self-reported alcohol use were maintained at the 3-month follow-up. This is the first randomized trial utilizing an accurate and validated biomarker (EtG) to demonstrate the efficacy of contingency management for alcohol dependence in outpatients with serious mental illness.
Toll, Benjamin A; White, Marney; Wu, Ran; Meandzija, Boris; Jatlow, Peter; Makuch, Robert; O'Malley, Stephanie S
2010-10-01
Fear of weight gain is a significant obstacle to smoking cessation, preventing some smokers from attempting to quit. Several previous studies of naltrexone yielded promising results for minimization of post-quit weight gain. Given these encouraging findings, we endeavored to test whether minimization of weight gain might translate to better quit outcomes for a population that is particularly concerned about gaining weight upon quitting. Smokers (N=172) in this investigation were prospectively randomized to receive either 25 mg naltrexone or placebo for 27 weeks (1 week pre-, 26 weeks post-quit) for minimization of post-quit weight gain and smoking cessation. All participants received open label therapy with the nicotine patch for the first 8 weeks post-quit and behavioral counseling over the 27-week treatment. The 2 pre-specified primary outcomes were change in weight for continuously abstinent participants and biologically verified end-of-treatment 7-day point-prevalence abstinence at 26 weeks after the quit date. The difference in weight at 26 weeks post-quit between the naltrexone and placebo groups (naltrexone: 6.8 lbs ± 8.94 vs placebo: 9.7 lbs ± 9.19, p = 0.45) was not statistically different. Seven-day point-prevalence smoking abstinence rates at 26 weeks post-quit was not significantly different between the 2 groups (naltrexone: 22% vs placebo: 27%, p = 0.43). For smokers high in weight concern, the relatively small reduction in weight gain with low-dose naltrexone is not worth the potential for somewhat lower rates of smoking abstinence. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.
Solli, Kristin Klemmetsby; Latif, Zill-E-Huma; Opheim, Arild; Krajci, Peter; Sharma-Haase, Kamni; Benth, Jūratė Šaltytė; Tanum, Lars; Kunoe, Nikolaj
2018-05-28
This is a follow-up study of a previously published randomized clinical trial conducted in Norway that compared extended-release naltrexone (XR-NTX) to buprenorphine-naloxone (BP-NLX) over 3 months. At the conclusion of the trial, participants were offered their choice of study medication for an additional 9 months. While BP-NLX was available at no cost through opioid maintenance treatment programmes, XR-NTX was available only through study participation, accounting for why almost all participants chose XR-NTX in the follow-up. The aim of this follow-up study was to compare differences in outcome between adults with opioid dependence continuing XR-NTX and those inducted on XR-NTX for a 9-month period, on measures of effectiveness, safety and feasibility. In this prospective cohort study, participants were either continuing XR-NTX, changed from BP-NLX to XR-NTX or re-included into the study and inducted on XR-NTX treatment. Five urban, out-patient addiction clinics in Norway. Opioid-dependent adults continuing (n = 54) or inducted on (n = 63) XR-NTX. XR-NTX administrated as intramuscular injections (380 mg) every fourth week. Data on retention, use of heroin and other illicit substances, opioid craving, treatment satisfaction, addiction-related problems and adverse events were reported every fourth week. Nine-month follow-up completion rates were 51.9% among participants continuing XR-NTX in the follow-up and 47.6% among those inducted on XR-NTX. Opioid abstinence rates were, respectively, 53.7 and 44.4%. No significant group differences were found in use of heroin and other opioids. Opioid-dependent individuals who elect to switch from buprenorphine-naltrexone treatment after 3 months to extended-release naltrexone treatment for 9 months appear to experience similar treatment completion and abstinence rates and similar adverse event profiles to individuals who had been on extended-release naltrexone from the start of treatment. © 2018 Society for the
Lähteenmäki, Ritva; Puustinen, Juha; Vahlberg, Tero; Lyles, Alan; Neuvonen, Pertti J; Partinen, Markku; Räihä, Ismo; Kivelä, Sirkka-Liisa
2014-01-01
Aim We compared the efficacy of melatonin and placebo as adjuvants in the withdrawal of patients from long term temazepam, zopiclone or zolpidem (here ‘BZD’) use. Methods A double-blind, placebo-controlled, randomized trial was conducted in a primary health care outpatient clinic. Ninety-two men or women (≥55 years) with primary insomnia and chronic BZD use received controlled release melatonin 2 mg (CRM) (n = 46) or placebo (n = 46) during the 1 month withdrawal from BZDs. Psychosocial support was provided. Follow-up continued for up to 6 months. Successful BZD withdrawal by the end of 1 month was confirmed by BZD plasma determinations, while reduction in BZD use and abstinence continuing for 6 months were noted. Results There were two drop-outs on CRM and one on placebo. After a 1 month withdrawal, 31 participants (67%; 95% CI 54, 81) on CRM and 39 (85%; 74, 95) on placebo had withdrawn completely (intention-to-treat analysis between groups, P = 0.051; per protocol P = 0.043). Reduction in BZD use was similar or even more rare in the CRM than in the placebo group (P = 0.052 per protocol). After 6 months, 14 participants in the CRM group and 20 in the placebo group remained non-users of BZD (NS between groups). BZD doses were higher in the CRM than in the placebo group at the end of the 6 month follow-up (P = 0.025). Withdrawal symptoms did not differ between the groups. Conclusions Gradual dose reduction of BZDs combined with CRM or placebo, and psychosocial support produced high short term and moderate long term BZD abstinence. CRM showed no withdrawal benefit compared with placebo. PMID:24286360
Abstinence Self-Efficacy and Abstinence 1 Year After Substance Use Disorder Treatment
ERIC Educational Resources Information Center
Ilgen, Mark; McKellar, John; Tiet, Quyen
2005-01-01
To better understand the relationship between abstinence self-efficacy and treatment outcomes in substance use disorder patients, experts in the field need more information about the levels of abstinence self-efficacy most predictive of treatment outcomes. Participants (N = 2,967) from 15 residential substance use disorder treatment programs were…
Summer School Effects in a Randomized Field Trial
ERIC Educational Resources Information Center
Zvoch, Keith; Stevens, Joseph J.
2013-01-01
This field-based randomized trial examined the effect of assignment to and participation in summer school for two moderately at-risk samples of struggling readers. Application of multiple regression models to difference scores capturing the change in summer reading fluency revealed that kindergarten students randomly assigned to summer school…
Gaalema, Diann E.; Scott, Teresa Linares; Heil, Sarah H.; Coyle, Mara G.; Kaltenbach, Karol; Badger, Gary J.; Arria, Amelia M.; Stine, Susan M.; Martin, Peter R.; Jones, Hendrée E.
2014-01-01
Aims To compare the profile of signs of neonatal abstinence syndrome (NAS) in methadone- versus buprenorphine-exposed infants. Design, setting and participants Secondary analysis of NAS data from a multi-site, double-blind, double-dummy, flexible-dosing, randomized clinical trial. Data from a total of 129 neonates born to opioid-dependent women who had been assigned to receive methadone or buprenorphine treatment during pregnancy were examined. Measurements For 10 days after delivery, neonates (methadone = 72, buprenorphine = 57) were assessed regularly using a 19-item modified Finnegan scale. Data from neonates who required pharmacological treatment (methadone = 41, buprenorphine = 27) were included up to the time treatment was initiated. The incidence and mean severity of the total NAS score and each individual sign of NAS were calculated and compared between medication conditions, as was the median time until morphine treatment initiation among treated infants in each condition. Findings Two NAS signs (undisturbed tremors and hyperactive Moro reflex) were observed significantly more frequently in methadone-exposed neonates and three (nasal stuffiness, sneezing, loose stools) were observed more frequently in buprenorphine-exposed neonates. Mean severity scores on the total NAS score and five individual signs (disturbed and undisturbed tremors, hyperactive Moro reflex, excessive irritability, failure to thrive) were significantly higher among methadone-exposed neonates, while sneezing was higher among buprenorphine-exposed neonates. Among treated neonates, methadone-exposed infants required treatment significantly earlier than buprenorphine-exposed infants (36 versus 59 hours postnatal, respectively). Conclusions The profile of neonatal abstinence syndrome differs in methadone- versus buprenorphine-exposed neonates, with significant differences in incidence, severity and treatment initiation time. Overall, methadone-exposed neonates have a more severe neonatal
ERIC Educational Resources Information Center
Taverner, Bill; Montfort, Sue
2011-01-01
Young people need to know that abstinence is a far more complex, difficult concept than it is often portrayed. Abstinence is a decision about sexual behaviors that a person may make throughout his or her life. It is a choice made at a specific time in a specific situation, for a specific period of time, whether one is in a partnered relationship…
Comparing Two Web-Based Smoking Cessation Programs: Randomized Controlled Trial
McKay, H Garth; Seeley, John R; Lichtenstein, Edward; Gau, Jeff M
2008-01-01
Background Smoking cessation remains a significant public health problem. Innovative interventions that use the Internet have begun to emerge that offer great promise in reaching large numbers of participants and encouraging widespread behavior change. To date, the relatively few controlled trials of Web-based smoking cessation programs have been limited by short follow-up intervals. Objective We describe the 6-month follow-up results of a randomized controlled trial in which participants recruited online were randomly assigned to either a Web-based smoking cessation program (Quit Smoking Network; QSN) or a Web-based exercise enhancement program (Active Lives) adapted somewhat to encourage smoking cessation. Methods The study was a two-arm randomized controlled trial that compared two Web-based smoking cessation programs: (1) the QSN intervention condition presented cognitive-behavioral strategies, and (2) the Active Lives control condition provided participants with guidance in developing a physical activity program to assist them with quitting. The QSN condition provided smoking cessation information and behavior change strategies while the Active Lives condition provided participants with physical activity recommendations and goal setting. The QSN condition was designed to be more engaging (eg, it included multimedia components) and to present much greater content than is typically found in smoking cessation programs. Results Contrary to our hypotheses, no between-condition differences in smoking abstinence were found at 3- and 6-month follow-up assessments. While participants in the QSN intervention condition spent more time than controls visiting the online program, the median number of 1.0 visit in each condition and the substantial attrition (60.8% at the 6-month follow-up) indicate that participants were not as engaged as we had expected. Conclusions Contrary to our hypothesis, our test of two Web-based smoking cessation conditions, an intervention and an
Whittaker, Robyn; Dorey, Enid; Bramley, Dale; Bullen, Chris; Denny, Simon; Elley, C Raina; Maddison, Ralph; McRobbie, Hayden; Parag, Varsha; Rodgers, Anthony; Salmon, Penny
2011-01-21
Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones. This social cognitive theory-based intervention (called "STUB IT") used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques. The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation. A randomized controlled trial was conducted with 6-month follow-up. Participants had to be 16 years of age or over, be current daily smokers, be ready to quit, and have a video message-capable phone. Recruitment targeted younger adults predominantly through radio and online advertising. Registration and data collection were completed online, prompted by text messages. The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date, role model, and timing of messages. Extra messages were available on demand to beat cravings and address lapses. The control group also set a quit date and received a general health video message sent to their phone every 2 weeks. The target sample size was not achieved due to difficulty recruiting young adult quitters. Of the 226 randomized participants, 47% (107/226) were female and 24% (54/226) were Maori (indigenous population of New Zealand). Their mean age was 27 years (SD 8.7), and there was a high level of nicotine addiction. Continuous abstinence at 6 months was 26.4% (29/110) in the intervention group and 27.6% (32/116) in the control group (P = .8). Feedback from participants indicated that the support provided by the video role models was important and appreciated. This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone. However, there was
[Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial].
Rozenberg, P; Deruelle, P; Sénat, M-V; Desbrière, R; Winer, N; Simon, E; Ville, Y; Kayem, G; Boutron, I
2018-04-01
The data from literature show that trial of labor and elective repeat cesarean delivery after a prior cesarean delivery both present significant risks and benefits, and these risks and benefits differ for the woman and her fetus. The benefits to the woman can be at the expense of her fetus and vice-versa. This uncertainty is compounded by the scarcity of high-level evidence that preclude accurate quantification of the risks and benefits that could help provide a fair counseling about a trial of labor and elective repeat cesarean delivery. An interesting way of research is to evaluate the potential benefits of a decision rule associated to the ultrasound measurement of the lower uterine segment (LUS). Indeed, ultrasonography may be helpful in determining a specific risk for a given patient by measuring the thickness of the LUS, i,e, the thickness of the cesarean delivery scar area. Although only small and often methodologically biased data have been published, they look promising as their results are concordant: ultrasonographic measurements of the LUS thickness is highly correlated with the intraoperative findings at cesarean delivery. Furthermore, the thinner the LUS becomes on ultrasound, the higher the likelihood of a defect in the LUS. Finally, ultrasound assessment of LUS has an excellent negative predictive value for the risk of uterine defect. Therefore, this exam associated with a rule of decision could help to reduce the rate of elective repeat cesarean delivery and especially to reduce the fetal and maternal mortality and morbidity related to trial of labor after a prior cesarean delivery. This is a pragmatic open multicenter randomized trial with two parallel arms. Randomization will be centralized and computerized. Since blindness is impossible, an adjudication committee will evaluate the components of the primary composite outcome in order to avoid evaluation bias. An interim analysis will be planned mid-strength of the trial. Ultrasound will be
Goodson, Patricia; Pruitt, B E; Suther, Sandy; Wilson, Kelly; Buhi, Eric
2006-04-01
Authors examined the logic (or the implicit theory) underlying 16 abstinence-only-until-marriage programs in Texas (50% of all programs funded under the federal welfare reform legislation during 2001 and 2002). Defined as a set of propositions regarding the relationship between program activities and their intended outcomes, program staff's implicit theories were summarized and compared to (a) data from studies on adolescent sexual behavior, (b) a theory-based model of youth abstinent behavior, and (c) preliminary findings from the national evaluation of Title V programs. Authors interviewed 62 program directors and instructors and employed selected principles of grounded theory to analyze interview data. Findings indicated that abstinence education staff could clearly articulate the logic guiding program activity choices. Comparisons between interview data and a theory-based model of adolescent sexual behavior revealed striking similarities. Implications of these findings for conceptualizing and evaluating abstinence-only-until-marriage (or similar) programs are examined.
Cluster Randomized Controlled Trial
Young, John; Chapman, Katie; Nixon, Jane; Patel, Anita; Holloway, Ivana; Mellish, Kirste; Anwar, Shamaila; Breen, Rachel; Knapp, Martin; Murray, Jenni; Farrin, Amanda
2015-01-01
Background and Purpose— We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. Methods— A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Results— Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was −0.6 points (95% confidence interval, −1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. Conclusions— This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. Clinical Trial Registration— URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. PMID:26152298
Gong, Jason; Baker, Christine L; Zou, Kelly H; Bruno, Marianna; Jumadilova, Zhanna; Lawrence, David; Wilson, Beth; Ewel, Cynthia
2016-12-01
Smoking is the leading preventable cause of death, and tobacco control professionals continue to make progress in cessation efforts. Pharmacists can assist smokers seeking to quit by offering counseling on smoking cessation pharmacotherapies. Pragmatic randomized trials are useful for investigating practical questions about an intervention's risks, benefits, and costs in routine clinical practice. To evaluate an enhanced pharmacy care (EPC) program involving personalized pharmacist-provided telephone counseling for supporting prescription smoking cessation medications compared with usual care (UC). Cigarette smokers filling a newly prescribed smoking cessation pharmacotherapy and with pharmacy benefits managed by Express Scripts were recruited. Qualified subjects were randomized 1:1 to EPC and UC. Subjects in EPC received 3 telephone-counseling sessions from specialist pharmacists during the early course of the study, while subjects in UC did not receive any counseling sessions. Study outcomes were collected through telephone contact and using the Express Scripts prescription database. The primary outcome assessed the 1-week point prevalence (PP) of smoking abstinence at the end of the trial (week 12). Secondary outcomes included 4-week PP at week 12 and adherence, evaluated by proportion of days covered (PDC), to prescribed smoking cessation pharmacotherapies. There were 1,017 randomized subjects. Among them, 1,002 subjects were included in the analysis, and 513 were randomized into EPC and 489 into UC. Baseline demographics, smoking history, and prescribed smoking cessation pharmacotherapies were comparable. Varenicline and nicotine replacement therapy (NRT) were most frequently prescribed for smoking cessation. In EPC, 46.0% received all 3 counseling sessions; 29.4% received 2 sessions; and 14.6% received 1 session. Overall, 353 subjects in EPC and 383 subjects in UC completed the week 12 assessment. In the analysis for 1-week PP of smoking abstinence at week 12
Sheffer, Christine E; Bickel, Warren K; Franck, Christopher T; Panissidi, Luana; Pittman, Jami C; Stayna, Helen; Evans, Shenell
2017-12-01
Evidence-based treatments for tobacco dependence are significantly less effective for smokers of lower socioeconomic status which contributes to socioeconomic disparities in smoking prevalence rates and health. We aimed to reduce the socioeconomic gradient in treatment outcomes by systematically adapting evidence-based, cognitive-behavioral treatment for tobacco dependence for diverse lower socioeconomic smokers. Participants were randomized to adapted or standard treatment, received six 1-h group treatment sessions, and were followed for six months. We examined the effectiveness of the adapted treatment to improve treatment outcomes for lower socioeconomic groups. Participants (n=227) were ethnically, racially, and socioeconomically diverse. The adapted treatment significantly reduced the days to relapse for the two lowest socioeconomic groups: SES1: M=76.6 (SD 72.9) vs. 38.3 (SD 60.1) days to relapse (RR=0.63 95% CI, 0.45, 0.88, p=0.0013); SES2: M=88.2 (SD 67.3) vs. 40.1 (SD 62.6 days to relapse (RR=0.57 95% CI, 0.18, 0.70, p=0.0024). Interactions between socioeconomic status and condition were significant for initial abstinence (OR=1.26, 95% CI 1.09, 1.46, p=0.002), approached significance for 3-month abstinence (OR=0.90, 95% CI 0.80, 1.01, p<0.071), and were not significant for 6-month abstinence (OR=0.99 95% CI 0.88, 1.10, p=0.795). No significant differences in long-term abstinence were observed. Systematic adaption of evidence-based treatment for tobacco dependence can significantly improve initial and short-term treatment outcomes for diverse lower socioeconomic smokers and reduce inequities in days to relapse. Novel methods of providing targeted extended support are needed to improve long-term outcomes. Copyright © 2017 Elsevier B.V. All rights reserved.
From randomized controlled trials to observational studies.
Silverman, Stuart L
2009-02-01
Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety.
Neutrality, abstinence, and the therapeutic alliance.
Meissner, W W
1998-01-01
Concepts of neutrality and abstinence are discussed in terms of the variant opinions about them, pro and con, with particular reference to efforts to dispense with them based on the unavoidable role of the analyst's personal influence and subjectivity in the analytic process. Stereotypes of both neutrality and abstinence are examined, and the therapeutic alliance established as the most appropriate context within which to articulate the essential and constructive role of effective analytic neutrality and abstinence. The alliance is not possible without the persistent exercise of both neutrality and abstinence; conversely, other components of the alliance are intended to facilitate and preserve neutrality and abstinence on the part of both analyst and analysand. These elements are essential factors in effective analytic practice.
Hagens, Petra; Pieterse, Marcel; van der Valk, Paul; van der Palen, Job
2017-12-01
Limited tobacco dependence treatment resources exist for smoking COPD patients not ready to quit. Smoking reduction may be a viable treatment approach if it prompts quit attempts and subsequent abstinence. This article describes the protocol of the REDUQ (REDUce and Quit) study, which examines whether smoking reduction counselling plus combination nicotine replacement therapy (NRT) is (cost-)effective in achieving long-term abstinence in smoking COPD patients not ready to quit. We conducted a two-centre, parallel-group, randomised controlled trial with 18 months follow-up in smoking outpatients with COPD. Patients not ready to quit within the next month but willing to reduce their smoking, were randomised to receive either intensive smoking reduction counselling plus combination NRT or a single information meeting plus self-help manual. Outcomes were assessed at baseline, 6, 12 and 18 months. The primary outcome is ≥ 1-year prolonged abstinence. Secondary outcomes are point prevalence abstinence, successful (i.e. ≥ 50%) smoking reduction, and incidence of quit attempts reported at follow-up assessments. Smoking status is biochemically verified by salivary cotinine and expired CO. Other variables include smoking-related cognitions, intention and motivation to reduce and quit smoking, withdrawal symptoms, health-related quality of life, symptoms of anxiety and depression, state of mindfulness, lung function, use of health care resources, and costs. The outcomes of the REDUQ trial will advance knowledge on treatment of smoking COPD patients not ready to quit. If (cost-)effective, the smoking reduction intervention can be offered to this difficult-to-treat target group as a valuable adjunct to smoking cessation treatment.
Treating neurocysticercosis medically: a systematic review of randomized, controlled trials.
Salinas, R; Counsell, C; Prasad, K; Gelband, H; Garner, P
1999-11-01
To summarize the evidence from randomized controlled trials on the effects of cysticidal therapy used for treating human cysticercosis. Published and unpublished studies in any language identified through MEDLINE (1966 - June 1999) specialized databases, abstracts, proceedings and contact with experts were analysed. Those which compared, using randomized or quasi-randomized methods, any cysticidal drug with placebo or symptomatic therapy were entered in the study. Data were extracted independently by two reviewers and trial quality assessed. Meta-analysis using fixed effects models calculated provided there was no significant heterogeneity, expressed as relative risk. Four trials met the inclusion criteria, treating intraparenchymatous neurocysticercosis with either albendazole or praziquantel compared to placebo or no treatment. In the two trials reporting clinical outcomes, treatment was not associated with a reduction in the risk of seizures, although numbers were small (RR 0.95, 95% CI 0.59-1.51). Four trials reported radiological outcomes, and cysticidal treatment was associated with a lower risk of cyst persistence of scans taken within six months of start of treatment (RR 0.83, 95% CI 0.70-0.99). Subsidiary analysis assuming different outcomes in patients lost to follow-up did not alter the findings of the main analysis. There is insufficient evidence to determine whether cysticidal therapy is of any clinical benefit to patients with neurocysticercosis. The review does not exclude the possibility that more patients remain seizure-free when treated with cysticidal drugs. Further testing through placebo-controlled trials is required.
Oluwoye, Oladunni; Skalisky, Jordan; Burduli, Ekaterina; Chaytor, Naomi S; McPherson, Sterling; Murphy, Sean M; Herron, Jalene; Hirchak, Katherine; Burley, Mason; Ries, Richard K; Roll, John M; McDonell, Michael G
2018-06-01
In contingency management (CM), individuals receive rewards for alcohol abstinence. CM is associated with reduced alcohol use in adults with co-occurring serious mental illnesses (SMI). Pre-treatment urine ethyl glucuronide (uEtG) levels equivalent to daily heavy drinking (uEtG >349ng/mL) are associated with poor response to CM. Modifications to CM are needed to improve outcomes for non-responders. To determine if pre-treatment heavy drinkers, defined by uEtG, with SMI achieve higher levels of alcohol abstinence when they receive an increased magnitude of reinforcement for abstinence (High-Magnitude CM) or reinforcers for reduced drinking, prior to receiving reinforcers for abstinence (Shaping CM), relative to those who receive typical low-magnitude abstinence based CM (Usual CM). Additionally, variables in the Addictions Neuroclinical Assessment model will be examined as treatment response moderators. Participants (N=400) will be recruited from two urban mental health organizations and complete a 4-week induction period where they will be reinforced for submitting samples for uEtG testing. Participants who attain a mean uEtG >349mg/mL will be randomized to receive either Usual CM, High-Magnitude CM, or Shaping CM for 16weeks. Differences in abstinence, assessed by uEtG, will be examined during treatment and during a 12-month follow-up. Measures of negative emotionality, alcohol reinforcer salience, and executive functioning will be gathered at study intake and used to predict treatment outcomes. This novel approach to CM will use an alcohol biomarker to identify those at risk for treatment non-response and determine if adaptations to CM might improve outcomes for this group. Copyright © 2018 Elsevier Inc. All rights reserved.
Koletsi, Despina; Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore
2012-06-01
In this study, we aimed to investigate whether studies published in orthodontic journals and titled as randomized clinical trials are truly randomized clinical trials. A second objective was to explore the association of journal type and other publication characteristics on correct classification. American Journal of Orthodontics and Dentofacial Orthopedics, European Journal of Orthodontics, Angle Orthodontist, Journal of Orthodontics, Orthodontics and Craniofacial Research, World Journal of Orthodontics, Australian Orthodontic Journal, and Journal of Orofacial Orthopedics were hand searched for clinical trials labeled in the title as randomized from 1979 to July 2011. The data were analyzed by using descriptive statistics, and univariable and multivariable examinations of statistical associations via ordinal logistic regression modeling (proportional odds model). One hundred twelve trials were identified. Of the included trials, 33 (29.5%) were randomized clinical trials, 52 (46.4%) had an unclear status, and 27 (24.1%) were not randomized clinical trials. In the multivariable analysis among the included journal types, year of publication, number of authors, multicenter trial, and involvement of statistician were significant predictors of correctly classifying a study as a randomized clinical trial vs unclear and not a randomized clinical trial. From 112 clinical trials in the orthodontic literature labeled as randomized clinical trials, only 29.5% were identified as randomized clinical trials based on clear descriptions of appropriate random number generation and allocation concealment. The type of journal, involvement of a statistician, multicenter trials, greater numbers of authors, and publication year were associated with correct clinical trial classification. This study indicates the need of clear and accurate reporting of clinical trials and the need for educating investigators on randomized clinical trial methodology. Copyright © 2012 American Association
The prompted optional randomization trial: a new design for comparative effectiveness research.
Flory, James; Karlawish, Jason
2012-12-01
Randomized controlled trials are the gold standard for medical evidence because randomization provides the best-known protection against confounding of results. Randomization has practical and ethical problems that limit the number of trials that can be conducted, however. A different method for collecting clinical data retains the statistically useful properties of randomization without incurring its practical and ethical challenges. A computerized prompt introduces a random element into clinical decision-making that can be instantly overridden if it conflicts with optimal patient care. This creates a weak form of randomization that still eliminates the effect of all confounders, can be carried out without disturbing routine clinical care, and arguably will not require research-grade informed consent.
Farris, Samantha G.; DiBello, Angelo M.; Heggeness, Luke F.; Reitzel, Lorraine R.; Vidrine, Damon J.; Schmidt, Norman B.; Zvolensky, Michael J.
2016-01-01
Background and Objectives Smoking-specific experiential avoidance is related to the maintenance of cigarette smoking. However, it is unclear whether sustained smoking abstinence is associated with subsequent reductions in smoking-specific experiential avoidance. Methods Daily smokers (n = 149) underwent a cessation attempt in the context of a 4-session smoking cessation treatment trial. Participants provided biochemical verification of smoking status at 1 week, 2 weeks, and 1 Month post-quit day. Smoking-specific experiential avoidance was assessed per the Avoidance and Inflexibility Scale (AIS) – the total score and two factor scores were examined at 1 Month post-quit day as a function of abstinence status. Two path models were conducted and included participant sex, treatment condition, and precessation nicotine dependence, smoking-specific experiential avoidance, and presence of emotional disorders as covariates. Results After adjusting for covariates, sustained smoking abstinence was associated with a reduction in the AIS total score at Month 1 post-quit (β = −.45, p < .001). Sustained smoking abstinence was associated with reductions across both facets of experiential avoidance -- smoking-related thoughts and feelings (β = −.44, p < .001) and internal bodily sensations (β = −.41, p < .001). Limitations Biochemical verification of smoking status was confirmed only at three time points post-quit day, and continued abstinence throughout the one-month post-quitting period is not fully known. Conclusions Sustained smoking abstinence may contribute to reductions in smoking-specific experiential avoidance. Findings contribute to the research documenting the relevance of experiential avoidance in various processes of smoking (including smoking abstinence). PMID:26773342
Free, Caroline; Hoile, Elizabeth; Robertson, Steven; Knight, Rosemary
2010-06-01
Recruitment is a major challenge for trials but there is little evidence regarding interventions to increase trial recruitment. We report three controlled trials of interventions to increase recruitment to the Txt2stop trial. To evaluate: Trial 1. The impact on registrations of a text message regarding an online registration facility; Trial 2. The impact on randomizations of sending pound5 with a covering letter to those eligible to join the trial; Trial 3. The impact on randomizations of text messages containing quotes from existing participants. Single blind controlled trials with allocation concealment. Trial 1: A text message regarding our new online registration facility; Trial 2: A letter with pound5 enclosed; Trial 3: A series of four text messages containing quotes from participants. The control group in each trial received standard Txt2stop procedures. Trial 1: 3.6% (17/470) of the intervention group and 1.1% (5/467) of the control group registered for the trial, risk difference 2.5% (95% CI 0.6-4.5). 0% (0/ 470) of the intervention group and 0.2% (1/467) of the control group registered successfully online, risk difference -0.2 (95% CI -0.6-0.2); Trial 2: 4.5% (11/246) of the intervention group and 0.4% (1/245) of the control group were randomized into the Txt2stop trial, risk difference 4.0% (95% CI 1.4-6.7); Trial 3: 3.5% (14/405) of the intervention group and 0% (0/406) of the control group were randomized into the Txt2stop trial, risk difference 3.5 (95% CI 1.7-5.2). There were no baseline data available for trial 1. Allocation of participant IDs in trials 2 and 3 were systematic. Sending a text message about an online registration facility increased registrations to Txt2stop, but did not increase online registrations. Sending a pound5 reimbursement for participants' time and sending text messages containing quotes from existing participants increased randomizations into the Txt2stop trial. Clinical Trials 2010; 7: 265-273. http://ctj.sagepub.com.
A Randomized Controlled Trial of the Group-Based Modified Story Memory Technique in TBI
2017-10-01
AWARD NUMBER: W81XWH-16-1-0726 TITLE: A Randomized Controlled Trial of the Group -Based Modified Story Memory Technique in TBI PRINCIPAL...2017 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER A Randomized Controlled Trial of the Group -Based Modified Story Memory Technique in TBI 5b. GRANT...forthcoming, The current study addresses this need through a double blind, placebo- controlled , randomized clinical trial (RCT) of a group
Abstinence education for urban youth.
Carter-Jessop, L; Franklin, L N; Heath, J W; Jimenez-Irizarry, G; Peace, M D
2000-08-01
Teen sexual problems in the U.S. are reaching enormous proportions. Attempts to prevent common problems, pregnancy and sexually transmitted diseases, are underway through the persistent efforts of community, health, academic and government organizations. Abstinence education is one of the current attempts. However, the lack of well defined theoretical frameworks and analyses of outcomes have limited progress in the study of abstinence education. This article describes a pilot program in abstinence-only education provided to six groups of young teens within an urban middle school. The framework for the program, cognitive social learning theory, is described and operationalized. Student pretest-posttest attitudes, open-ended written comments about the program and the researchers' anecdotes about behavioral changes in the students are the outcome measures. Positive attitudes about premarital abstinence increased for all six groups; for four of the six groups the increase was statistically significant.
Bernstein, Steven L; Weiss, June-Marie; Toll, Benjamin; Zbikowski, Susan M
2016-12-01
Quitlines (QL) are an effective means for smoking cessation, but a paucity of data exist examining the dose-response relationship between use of QL services and quit rates, especially among low-income smokers. The purpose of this study was to study the relationship between tobacco abstinence and use of QL services among low-income smokers. Secondary analysis of a randomized trial of every- or some-day smokers aged 18 years or older visiting an urban emergency department. Inclusion criteria included self-pay or Medicaid insurance, as a proxy for low-income and low socioeconomic status. Intervention participants received a motivational interview, 6 weeks of nicotine patches and gum, a referral faxed to the state-sponsored QL, a booster call, and a quitline brochure. Control participants received the brochure. Smoking status was assessed by phone at 1 and 3 months, with confirmation via exhaled carbon monoxide testing at 3 months for those reporting abstinence. QL usage was obtained by utilization data from the QL database. Of 778 subjects, 197 (25.3%) reported any use of QL services at 3 months. Participants were trichotomized: no QL usage, 1 call only, and >1 call (583, 99, and 98 participants, respectively). Quit rates at 3 months in these no, low-, and high-use groups were, respectively, 7.2%, 9.1%, and 15.3% (P=0.03). Participants who used the QL had a median of 28 total minutes of telephone contact. Among low-income smokers, greater use of QL services is associated with higher abstinence. Whether this resulted from a direct effect of the QL, or greater motivation among smokers using QL services cannot be determined from these data. Copyright © 2016 Elsevier Inc. All rights reserved.
Hassandra, Mary; Lintunen, Taru; Hagger, Martin S; Heikkinen, Risto; Vanhala, Mauno; Kettunen, Tarja
2017-05-26
While gains in reducing smoking rates in Finland have been made, prevalence rates are still substantial. Relapse rates among smokers engaged in quit-smoking programs are high. Physical activity has been proposed as one means to help smokers manage cravings. Software and apps on mobile phone and handheld devices offer an opportunity to communicate messages on how to use physical activity to manage cravings as part of quit-smoking programs. We aimed to test the feasibility, acceptability, usability, and preliminary efficacy of an mHealth mobile phone app, Physical activity over Smoking (PhoS), to assist smokers in quitting smoking in a randomized controlled trial. The app was designed to prompt smokers to engage in physical activities to manage their smoking cravings. Regular smokers (n=44) attended a group-based behavioral counselling program aimed at promoting physical activity as an additional aid to quit. After quit day, participants were randomly allocated to an intervention (n=25) or to a comparison (n=19) group. Participants in the intervention group were provided with the PhoS app and training on how to use it to assist with relapse prevention. Participants in the comparison condition were provided with generalized relapse prevention training. Some participants reported that the PhoS app was useful in assisting them to successfully manage their cigarette cravings, although compliance across the sample was modest and participants reported low levels of usability. Participants receiving the PhoS app did not report greater abstinence than those who did not receive the app. However, participants receiving the app were more likely to report greater abstinence if they did not use pharmacological support, while those who did not receive the app reported greater abstinence when using pharmacological support. Participants receiving the app reported greater levels of physical activity than those who did not. Results revealed that the app resulted in better retention
Resistant hypertension optimal treatment trial: a randomized controlled trial.
Krieger, Eduardo M; Drager, Luciano F; Giorgi, Dante Marcelo Artigas; Krieger, Jose Eduardo; Pereira, Alexandre Costa; Barreto-Filho, José Augusto Soares; da Rocha Nogueira, Armando; Mill, José Geraldo
2014-01-01
The prevalence of resistant hypertension (ReHy) is not well established. Furthermore, diuretics, angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers, and calcium channel blockers are largely used as the first 3-drug combinations for treating ReHy. However, the fourth drug to be added to the triple regimen is still controversial and guided by empirical choices. We sought (1) to determine the prevalence of ReHy in patients with stage II hypertension; (2) to compare the effects of spironolactone vs clonidine, when added to the triple regimen; and (3) to evaluate the role of measuring sympathetic and renin-angiotensin-aldosterone activities in predicting blood pressure response to spironolactone or clonidine. The Resistant Hypertension Optimal Treatment (ReHOT) study (ClinicalTrials.gov NCT01643434) is a prospective, multicenter, randomized trial comprising 26 sites in Brazil. In step 1, 2000 patients will be treated according to hypertension guidelines for 12 weeks, to detect the prevalence of ReHy. Medical therapy adherence will be checked by pill count monitoring. In step 2, patients with confirmed ReHy will be randomized to an open label 3-month treatment with spironolactone (titrating dose, 12.5-50 mg once daily) or clonidine (titrating dose, 0.1-0.3 mg twice daily). The primary endpoint is the effective control of blood pressure after a 12-week randomized period of treatment. The ReHOT study will disseminate results about the prevalence of ReHy in stage II hypertension and the comparison of spironolactone vs clonidine for blood pressure control in patients with ReHy under 3-drug standard regimen. © 2013 Wiley Periodicals, Inc.
Arnaud, Nicolas; Bröning, Sonja; Drechsel, Magdalena; Thomasius, Rainer; Baldus, Christiane
2012-09-26
Mid to late adolescence is characterised by a vulnerability to problematic substance use since the consumption of alcohol and illicit drugs is frequently initiated and increased in this life period. While the detrimental long- and short-term effects of problematic consumption patterns in adolescence pose a major public health concern, current prevention programs targeting alcohol- and other substance-using adolescents are scarce. The study described in this protocol will test the effectiveness of a web-based brief intervention aimed at reducing problematic alcohol use and promoting abstinence from illegal drugs in adolescents with risky substance use aged 16 to 18 years old in four EU-countries. To determine the effectiveness of our web-BI, we apply a two-arm randomized controlled trial (RCT) study design, with baseline assessment at study entry and a three month follow-up assessment. Adolescents aged 16 to 18 years from Belgium, the Czech Republic, Germany, and Sweden will be randomly assigned to either the fully electronically delivered brief intervention group (N = 400) or an assessment only control group (N = 400) depending on their screening for risky substance use (using the CRAFFT). Recruitment, informed consent, randomization, intervention and follow-up will be implemented online. Primary outcomes are reductions in frequency and quantity of use of alcohol and drugs other than alcohol over a 30 day period, as well as consumption per typical occasion. Secondary outcomes concern changes in substance use related cognitions including the constructs of the Theory of Planned Behaviour, implementation intentions, and stages of change. Moreover the study addresses a number of moderator variables, including age of first use, general psychopathology and quality of parent-child relationship. The trial is expected to contribute to the growing literature on theory- and web-based brief interventions for adolescents. We will explore the potential of using web
Nollen, Nicole L; Mayo, Matthew S; Sanderson Cox, Lisa; Okuyemi, Kolawole S; Choi, Won S; Kaur, Harsohena; Ahluwalia, Jasjit S
2006-01-01
OBJECTIVE To examine the predictors of quitting among African American (AA) light smokers (<10 cigarettes per day) enrolled in a smoking cessation trial. METHODS Baseline variables were analyzed as potential predictors from a 2 × 2 cessation trial in which participants were randomly assigned to 1 of 4 treatment groups: nicotine gum plus health education (HE) counseling, nicotine gum plus motivational interviewing (MI) counseling, placebo gum plus HE counseling, or placebo gum plus MI counseling. Chi-square tests, 2 sample t-tests, and multiple logistic regression analyses were used to identify predictors of cotinine (COT) verified abstinence at month 6. RESULTS In the final regression model, HE rather than MI counseling (odds ratio [OR]=2.26%, 95% confidence interval [CI]=1.36 to 3.74), older age (OR=1.03%, 95% CI=1.01 to 1.06), and higher body mass index (OR=1.04%, 95% CI=1.01 to 1.07) significantly increased the likelihood of quitting, while female gender (OR=0.46%, 95% CI=0.28 to 0.76),≤$1,800/month income (OR=0.60%, 95% CI=0.37 to 0.97), higher baseline COT (OR=0.948%, 95% CI=0.946 to 0.950), and not completing all counseling sessions (OR=0.48%, 95% CI=0.27 to 0.84) reduced the odds of quitting. CONCLUSIONS Individual characteristics may decrease the likelihood of quitting; however, the provision of directive, advice-oriented counseling focused on the addictive nature of nicotine, health consequences of smoking, benefits of quitting, and development of a concrete quit plan may be an important and effective facilitator of quitting among AA light smokers. PMID:16808741
Walitzer, Kimberly S; Deffenbacher, Jerry L; Shyhalla, Kathleen
2015-12-01
A randomized controlled trial for an innovative alcohol-adapted anger management treatment (AM) for outpatient alcohol dependent individuals scoring moderate or above on anger is described. AM treatment outcomes were compared to those of an empirically-supported intervention, Alcoholics Anonymous Facilitation treatment (AAF). Clients in AM, relative to clients in AAF, were hypothesized to have greater improvement in anger and anger-related cognitions and lesser AA involvement during the 6-month follow-up. Anger-related variables were hypothesized to be stronger predictors of improved alcohol outcomes in the AM treatment condition and AA involvement was hypothesized to be a stronger predictor of alcohol outcomes in the AAF treatment group. Seventy-six alcohol dependent men and women were randomly assigned to treatment condition and followed for 6 months after treatment end. Both AM and AAF treatments were followed by significant reductions in heavy drinking days, alcohol consequences, anger, and maladaptive anger-related thoughts and increases in abstinence and self-confidence regarding not drinking to anger-related triggers. Treatment with AAF was associated with greater AA involvement relative to treatment with AM. Changes in anger and AA involvement were predictive of posttreatment alcohol outcomes for both treatments. Change in trait anger was a stronger predictor of posttreatment alcohol consequences for AM than for AAF clients; during-treatment AA meeting attendance was a stronger predictor of posttreatment heavy drinking and alcohol consequences for AAF than for AM clients. Anger-related constructs and drinking triggers should be foci in treatment of alcohol dependence for anger-involved clients. Copyright © 2015 Elsevier Inc. All rights reserved.
Walitzer, Kimberly S.; Deffenbacher, Jerry L.; Shyhalla, Kathleen
2015-01-01
A randomized controlled trial for an innovative alcohol-adapted anger management treatment (AM) for outpatient alcohol dependent individuals scoring moderate or above on anger is described. AM treatment outcomes were compared to those of an empirically-supported intervention, Alcoholics Anonymous Facilitation treatment (AAF). Clients in AM, relative to clients in AAF, were hypothesized to have greater improvement in anger and anger-related cognitions and lesser AA involvement during the six-month follow-up. Anger-related variables were hypothesized to be stronger predictors of improved alcohol outcomes in the AM treatment condition and AA involvement was hypothesized to be a stronger predictor of alcohol outcomes in the AAF treatment group. Seventy-six alcohol dependent men and women were randomly assigned to treatment condition and followed for six months after treatment end. Both AM and AAF treatments were followed by significant reductions in heavy drinking days, alcohol consequences, anger, and maladaptive anger-related thoughts and increases in abstinence and self-confidence regarding not drinking to anger-related triggers. Treatment with AAF was associated with greater AA involvement relative to treatment with AM. Changes in anger and AA involvement were predictive of posttreatment alcohol outcomes for both treatments. Change in trait anger was a stronger predictor of posttreatment alcohol consequences for AM than for AAF clients; during-treatment AA meeting attendance was a stronger predictor of posttreatment heavy drinking and alcohol consequences for AAF than for AM clients. Anger-related constructs and drinking triggers should be foci in treatment of alcohol dependence for anger-involved clients. PMID:26387049
Smoking Abstinence, Eating Style, and Food Intake.
ERIC Educational Resources Information Center
Duffy, Joanne; Hall, Sharon M.
1988-01-01
Administered the Eating Inventory and the Profile of Mood States (POMS) to smoking subjects assigned to cigarette abstinence or to continued smoking. Found abstinent smokers with high Disinhibition Scale scores overate more than did nonabstinent smokers or abstinent smokers with lower scores when participating in a subsequent ice cream tasting…
Cannabis Abstinence During Treatment and One-Year Follow-Up: Relationship to Neural Activity in Men
Kober, Hedy; DeVito, Elise E; DeLeone, Cameron M; Carroll, Kathleen M; Potenza, Marc N
2014-01-01
Cannabis is among the most frequently abused substances in the United States. Cognitive control is a contributory factor in the maintenance of substance-use disorders and may relate to treatment response. Therefore, we assessed whether cognitive-control-related neural activity before treatment differs between treatment-seeking cannabis-dependent and healthy individuals and relates to cannabis-abstinence measures during treatment and 1-year follow-up. Cannabis-dependent males (N=20) completed a functional magnetic resonance imaging (fMRI) cognitive-control (Stroop) task before a 12-week randomized controlled trial of cognitive–behavioral therapy and/or contingency management. A healthy-comparison group (N=20) also completed the fMRI task. Cannabis use was assessed by urine toxicology and self-report during treatment, and by self-report across a 1-year follow-up period (N=18). The cannabis-dependent group displayed diminished Stroop-related neural activity relative to the healthy-comparison group in multiple regions, including those strongly implicated in cognitive-control and addiction-related processes (eg, dorsolateral prefrontal cortex and ventral striatum). The groups did not differ significantly in response times (cannabis-dependent, N=12; healthy-comparison, N=14). Within the cannabis-dependent group, greater Stroop-related activity in regions including the dorsal anterior cingulate cortex was associated with less cannabis use during treatment. Greater activity in regions including the ventral striatum was associated with less cannabis use during 1-year posttreatment follow-up. These data suggest that lower cognitive-control-related neural activity in classic ‘control' regions (eg, dorsolateral prefrontal cortex and dorsal anterior cingulate) and classic ‘salience/reward/learning' regions (eg, ventral striatum) differentiates cannabis-dependent individuals from healthy individuals and relates to less abstinence within-treatment and during long
Cannabis abstinence during treatment and one-year follow-up: relationship to neural activity in men.
Kober, Hedy; DeVito, Elise E; DeLeone, Cameron M; Carroll, Kathleen M; Potenza, Marc N
2014-09-01
Cannabis is among the most frequently abused substances in the United States. Cognitive control is a contributory factor in the maintenance of substance-use disorders and may relate to treatment response. Therefore, we assessed whether cognitive-control-related neural activity before treatment differs between treatment-seeking cannabis-dependent and healthy individuals and relates to cannabis-abstinence measures during treatment and 1-year follow-up. Cannabis-dependent males (N=20) completed a functional magnetic resonance imaging (fMRI) cognitive-control (Stroop) task before a 12-week randomized controlled trial of cognitive-behavioral therapy and/or contingency management. A healthy-comparison group (N=20) also completed the fMRI task. Cannabis use was assessed by urine toxicology and self-report during treatment, and by self-report across a 1-year follow-up period (N=18). The cannabis-dependent group displayed diminished Stroop-related neural activity relative to the healthy-comparison group in multiple regions, including those strongly implicated in cognitive-control and addiction-related processes (eg, dorsolateral prefrontal cortex and ventral striatum). The groups did not differ significantly in response times (cannabis-dependent, N=12; healthy-comparison, N=14). Within the cannabis-dependent group, greater Stroop-related activity in regions including the dorsal anterior cingulate cortex was associated with less cannabis use during treatment. Greater activity in regions including the ventral striatum was associated with less cannabis use during 1-year posttreatment follow-up. These data suggest that lower cognitive-control-related neural activity in classic 'control' regions (eg, dorsolateral prefrontal cortex and dorsal anterior cingulate) and classic 'salience/reward/learning' regions (eg, ventral striatum) differentiates cannabis-dependent individuals from healthy individuals and relates to less abstinence within-treatment and during long-term follow
Geier, Charles F; Sweitzer, Maggie M; Denlinger, Rachel; Sparacino, Gina; Donny, Eric C
2014-08-30
Chronic smoking may result in reduced sensitivity to non-drug rewards (e.g., money), a phenomenon particularly salient during abstinence. During a quit attempt, this effect may contribute to biased decision-making (smoking>alternative reinforcers) and relapse. Although relevant for quitting, characterization of reduced reward function in abstinent smokers remains limited. Moreover, how attenuated reward function affects other brain systems supporting decision-making has not been established. Here, we use a rewarded antisaccade (rAS) task to characterize non-drug reward processing and its influence on inhibitory control, key elements underlying decision-making, in abstinent smokers vs. non-smokers. Abstinent (12-hours) adult daily smokers (N=23) and non-smokers (N=11) underwent fMRI while performing the rAS. Behavioral performances improved on reward vs. neutral trials. Smokers showed attenuated activation in ventral striatum during the reward cue and in superior precentral sulcus and posterior parietal cortex during response preparation, but greater responses during the saccade response in posterior cingulate and parietal cortices. Smokers' attenuated anticipatory responses suggest reduced motivation from monetary reward, while heightened activation during the saccade response suggests that additional circuitry may be engaged later to enhance inhibitory task performance. Overall, this preliminary study highlights group differences in decision-making components and the utility of the rAS to characterize these effects. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
Venniro, Marco; Zhang, Michelle; Bossert, Jennifer M.; Warren, Brandon L.; Hope, Bruce T.
2017-01-01
We recently developed a rat model of incubation of methamphetamine craving after choice-based voluntary abstinence. Here, we studied the role of dorsolateral striatum (DLS) and dorsomedial striatum (DMS) in this incubation. We trained rats to self-administer palatable food pellets (6 d, 6 h/d) and methamphetamine (12 d, 6 h/d). We then assessed relapse to methamphetamine seeking under extinction conditions after 1 and 21 abstinence days. Between tests, the rats underwent voluntary abstinence (using a discrete choice procedure between methamphetamine and food; 20 trials/d) for 19 d. We used in situ hybridization to measure the colabeling of the activity marker Fos with Drd1 and Drd2 in DMS and DLS after the tests. Based on the in situ hybridization colabeling results, we tested the causal role of DMS D1 and D2 family receptors, and DMS neuronal ensembles in “incubated” methamphetamine seeking, using selective dopamine receptor antagonists (SCH39166 or raclopride) and the Daun02 chemogenetic inactivation procedure, respectively. Methamphetamine seeking was higher after 21 d of voluntary abstinence than after 1 d (incubation of methamphetamine craving). The incubated response was associated with increased Fos expression in DMS but not in DLS; Fos was colabeled with both Drd1 and Drd2. DMS injections of SCH39166 or raclopride selectively decreased methamphetamine seeking after 21 abstinence days. In Fos-lacZ transgenic rats, selective inactivation of relapse test-activated Fos neurons in DMS on abstinence day 18 decreased incubated methamphetamine seeking on day 21. Results demonstrate a role of DMS dopamine D1 and D2 receptors in the incubation of methamphetamine craving after voluntary abstinence and that DMS neuronal ensembles mediate this incubation. SIGNIFICANCE STATEMENT In human addicts, abstinence is often self-imposed and relapse can be triggered by exposure to drug-associated cues that induce drug craving. We recently developed a rat model of incubation
Caprioli, Daniele; Venniro, Marco; Zhang, Michelle; Bossert, Jennifer M; Warren, Brandon L; Hope, Bruce T; Shaham, Yavin
2017-01-25
We recently developed a rat model of incubation of methamphetamine craving after choice-based voluntary abstinence. Here, we studied the role of dorsolateral striatum (DLS) and dorsomedial striatum (DMS) in this incubation. We trained rats to self-administer palatable food pellets (6 d, 6 h/d) and methamphetamine (12 d, 6 h/d). We then assessed relapse to methamphetamine seeking under extinction conditions after 1 and 21 abstinence days. Between tests, the rats underwent voluntary abstinence (using a discrete choice procedure between methamphetamine and food; 20 trials/d) for 19 d. We used in situ hybridization to measure the colabeling of the activity marker Fos with Drd1 and Drd2 in DMS and DLS after the tests. Based on the in situ hybridization colabeling results, we tested the causal role of DMS D 1 and D 2 family receptors, and DMS neuronal ensembles in "incubated" methamphetamine seeking, using selective dopamine receptor antagonists (SCH39166 or raclopride) and the Daun02 chemogenetic inactivation procedure, respectively. Methamphetamine seeking was higher after 21 d of voluntary abstinence than after 1 d (incubation of methamphetamine craving). The incubated response was associated with increased Fos expression in DMS but not in DLS; Fos was colabeled with both Drd1 and Drd2 DMS injections of SCH39166 or raclopride selectively decreased methamphetamine seeking after 21 abstinence days. In Fos-lacZ transgenic rats, selective inactivation of relapse test-activated Fos neurons in DMS on abstinence day 18 decreased incubated methamphetamine seeking on day 21. Results demonstrate a role of DMS dopamine D 1 and D 2 receptors in the incubation of methamphetamine craving after voluntary abstinence and that DMS neuronal ensembles mediate this incubation. In human addicts, abstinence is often self-imposed and relapse can be triggered by exposure to drug-associated cues that induce drug craving. We recently developed a rat model of incubation of methamphetamine
Gabrovec, Branko
2015-01-01
The objective of our research was to discover whether the new approach to urine drug testing has a positive effect on users' abstinence, users' treatment, and their cooperation, while remaining user-friendly, and whether this approach is more cost-effective. The centers are focused on providing high-quality treatment within a cost-efficient program. In this study, we focus on the influence of drug testing and benefit-based distribution of opioid substitution therapy (BBDOST) on drug abstinence. The purpose of this study was to find any possible positive effect of modified distribution of the therapy and illicit drug testing on the number of users who are abstinent from illicit drugs and users who are not abstinent from illicit drugs as well as the users' opinion on BBDOST and testing. We are also interested in a difference in abstinence rates between those on BBDOST and those not receiving BBDOST. In 2010, the method of drug testing at the center was changed (less frequent and random drug testing) to enable its users faster access to BBDOST (take-home therapy). It was found that the number of drug-abstinent program participants has increased from initial 44.5% (2010) to 54.1% (2014). According to the program participants, the new method allows them to achieve and maintain abstinence from drugs more easily. In addition, they are also satisfied with the modified way of drug testing. This opinion does not change with age, gender, and acquired benefits.
The impact of adolescent binge drinking and sustained abstinence on affective state.
Bekman, Nicole M; Winward, Jennifer L; Lau, Lily L; Wagner, Chase C; Brown, Sandra A
2013-08-01
While it is clear that affect is negatively impacted by heavy drinking in adulthood and that it improves with abstinence, little is known about effects of heavy drinking on mood during adolescence. This study examined negative mood states among 2 groups of 16- to 18-year-old high school students; youth with a history of recent heavy episodic drinking (HED; n = 39) and comparison youth with limited lifetime drinking experience (CON; n = 26). Affect was assessed at 3 time points during a 4- to 6-week period of monitored abstinence using the Hamilton Rating Scales for Anxiety and Depression; self-reports were obtained with the state portion of the State-Trait Anxiety Inventory, and experience sampling of current affect was assessed via daily text messages sent at randomly determined times in the morning, afternoon, and evening. Youth with a recent history of HED reported more negative affect compared with nondrinking youth during early stages of abstinence (days since last HED at assessment 1: M = 6.46; SD = 5.06); however, differences in affect were not observed after 4 to 6 weeks of abstinence. Sex differences were evident, with HED girls reporting greater depression and anxiety than HED male peers. Although not significant, response patterns indicated that boys may experience faster resolution of negative emotional states than girls with sustained abstinence. Findings suggest that high-dose drinking is associated with elevated negative affect for adolescents and that negative mood states may take longer to resolve for girls than for boys following heavy drinking episodes. Future research clarifying naturally occurring changes in affective response during early and sustained abstinence is necessary for improving programs designed to promote adolescent decision-making and to reduce risk for relapse. Copyright © 2013 by the Research Society on Alcoholism.
Schlam, Tanya R; Fiore, Michael C; Smith, Stevens S; Fraser, David; Bolt, Daniel M; Collins, Linda M; Mermelstein, Robin; Piper, Megan E; Cook, Jessica W; Jorenby, Douglas E; Loh, Wei-Yin; Baker, Timothy B
2016-01-01
To identify promising intervention components that help smokers attain and maintain abstinence during a quit attempt. A 2 × 2 × 2 × 2 × 2 randomized factorial experiment. Eleven primary care clinics in Wisconsin, USA. A total of 544 smokers (59% women, 86% white) recruited during primary care visits and motivated to quit. Five intervention components designed to help smokers attain and maintain abstinence: (1) extended medication (26 versus 8 weeks of nicotine patch + nicotine gum); (2) maintenance (phone) counseling versus none; (3) medication adherence counseling versus none; (4) automated (medication) adherence calls versus none; and (5) electronic medication monitoring with feedback and counseling versus electronic medication monitoring alone. The primary outcome was 7-day self-reported point-prevalence abstinence 1 year after the target quit day. Only extended medication produced a main effect. Twenty-six versus 8 weeks of medication improved point-prevalence abstinence rates (43 versus 34% at 6 months; 34 versus 27% at 1 year; P = 0.01 for both). There were four interaction effects at 1 year, showing that an intervention component's effectiveness depended upon the components with which it was combined. Twenty-six weeks of nicotine patch + nicotine gum (versus 8 weeks) and maintenance counseling provided by phone are promising intervention components for the cessation and maintenance phases of smoking treatment. © 2015 Society for the Study of Addiction.
Ghiglietti, Andrea; Scarale, Maria Giovanna; Miceli, Rosalba; Ieva, Francesca; Mariani, Luigi; Gavazzi, Cecilia; Paganoni, Anna Maria; Edefonti, Valeria
2018-03-22
Recently, response-adaptive designs have been proposed in randomized clinical trials to achieve ethical and/or cost advantages by using sequential accrual information collected during the trial to dynamically update the probabilities of treatment assignments. In this context, urn models-where the probability to assign patients to treatments is interpreted as the proportion of balls of different colors available in a virtual urn-have been used as response-adaptive randomization rules. We propose the use of Randomly Reinforced Urn (RRU) models in a simulation study based on a published randomized clinical trial on the efficacy of home enteral nutrition in cancer patients after major gastrointestinal surgery. We compare results with the RRU design with those previously published with the non-adaptive approach. We also provide a code written with the R software to implement the RRU design in practice. In detail, we simulate 10,000 trials based on the RRU model in three set-ups of different total sample sizes. We report information on the number of patients allocated to the inferior treatment and on the empirical power of the t-test for the treatment coefficient in the ANOVA model. We carry out a sensitivity analysis to assess the effect of different urn compositions. For each sample size, in approximately 75% of the simulation runs, the number of patients allocated to the inferior treatment by the RRU design is lower, as compared to the non-adaptive design. The empirical power of the t-test for the treatment effect is similar in the two designs.
A randomized, controlled trial of oral propranolol in infantile hemangioma.
Léauté-Labrèze, Christine; Hoeger, Peter; Mazereeuw-Hautier, Juliette; Guibaud, Laurent; Baselga, Eulalia; Posiunas, Gintas; Phillips, Roderic J; Caceres, Hector; Lopez Gutierrez, Juan Carlos; Ballona, Rosalia; Friedlander, Sheila Fallon; Powell, Julie; Perek, Danuta; Metz, Brandie; Barbarot, Sebastien; Maruani, Annabel; Szalai, Zsuzsanna Zsofia; Krol, Alfons; Boccara, Olivia; Foelster-Holst, Regina; Febrer Bosch, Maria Isabel; Su, John; Buckova, Hana; Torrelo, Antonio; Cambazard, Frederic; Grantzow, Rainer; Wargon, Orli; Wyrzykowski, Dariusz; Roessler, Jochen; Bernabeu-Wittel, Jose; Valencia, Adriana M; Przewratil, Przemyslaw; Glick, Sharon; Pope, Elena; Birchall, Nicholas; Benjamin, Latanya; Mancini, Anthony J; Vabres, Pierre; Souteyrand, Pierre; Frieden, Ilona J; Berul, Charles I; Mehta, Cyrus R; Prey, Sorilla; Boralevi, Franck; Morgan, Caroline C; Heritier, Stephane; Delarue, Alain; Voisard, Jean-Jacques
2015-02-19
Oral propranolol has been used to treat complicated infantile hemangiomas, although data from randomized, controlled trials to inform its use are limited. We performed a multicenter, randomized, double-blind, adaptive, phase 2-3 trial assessing the efficacy and safety of a pediatric-specific oral propranolol solution in infants 1 to 5 months of age with proliferating infantile hemangioma requiring systemic therapy. Infants were randomly assigned to receive placebo or one of four propranolol regimens (1 or 3 mg of propranolol base per kilogram of body weight per day for 3 or 6 months). A preplanned interim analysis was conducted to identify the regimen to study for the final efficacy analysis. The primary end point was success (complete or nearly complete resolution of the target hemangioma) or failure of trial treatment at week 24, as assessed by independent, centralized, blinded evaluations of standardized photographs. Of 460 infants who underwent randomization, 456 received treatment. On the basis of an interim analysis of the first 188 patients who completed 24 weeks of trial treatment, the regimen of 3 mg of propranolol per kilogram per day for 6 months was selected for the final efficacy analysis. The frequency of successful treatment was higher with this regimen than with placebo (60% vs. 4%, P<0.001). A total of 88% of patients who received the selected propranolol regimen showed improvement by week 5, versus 5% of patients who received placebo. A total of 10% of patients in whom treatment with propranolol was successful required systemic retreatment during follow-up. Known adverse events associated with propranolol (hypoglycemia, hypotension, bradycardia, and bronchospasm) occurred infrequently, with no significant difference in frequency between the placebo group and the groups receiving propranolol. This trial showed that propranolol was effective at a dose of 3 mg per kilogram per day for 6 months in the treatment of infantile hemangioma. (Funded by
Brown, Alexandra R; Gajewski, Byron J; Aaronson, Lauren S; Mudaranthakam, Dinesh Pal; Hunt, Suzanne L; Berry, Scott M; Quintana, Melanie; Pasnoor, Mamatha; Dimachkie, Mazen M; Jawdat, Omar; Herbelin, Laura; Barohn, Richard J
2016-08-31
In the last few decades, the number of trials using Bayesian methods has grown rapidly. Publications prior to 1990 included only three clinical trials that used Bayesian methods, but that number quickly jumped to 19 in the 1990s and to 99 from 2000 to 2012. While this literature provides many examples of Bayesian Adaptive Designs (BAD), none of the papers that are available walks the reader through the detailed process of conducting a BAD. This paper fills that gap by describing the BAD process used for one comparative effectiveness trial (Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations) that can be generalized for use by others. A BAD was chosen with efficiency in mind. Response-adaptive randomization allows the potential for substantially smaller sample sizes, and can provide faster conclusions about which treatment or treatments are most effective. An Internet-based electronic data capture tool, which features a randomization module, facilitated data capture across study sites and an in-house computation software program was developed to implement the response-adaptive randomization. A process for adapting randomization with minimal interruption to study sites was developed. A new randomization table can be generated quickly and can be seamlessly integrated in the data capture tool with minimal interruption to study sites. This manuscript is the first to detail the technical process used to evaluate a multisite comparative effectiveness trial using adaptive randomization. An important opportunity for the application of Bayesian trials is in comparative effectiveness trials. The specific case study presented in this paper can be used as a model for conducting future clinical trials using a combination of statistical software and a web-based application. ClinicalTrials.gov Identifier: NCT02260388 , registered on 6 October 2014.
Vollstädt-Klein, Sabine; Loeber, Sabine; Kirsch, Martina; Bach, Patrick; Richter, Anne; Bühler, Mira; von der Goltz, Christoph; Hermann, Derik; Mann, Karl; Kiefer, Falk
2011-06-01
In alcohol-dependent patients, alcohol-associated cues elicit brain activation in mesocorticolimbic networks involved in relapse mechanisms. Cue-exposure based extinction training (CET) has been shown to be efficacious in the treatment of alcoholism; however, it has remained unexplored whether CET mediates its therapeutic effects via changes of activity in mesolimbic networks in response to alcohol cues. In this study, we assessed CET treatment effects on cue-induced responses using functional magnetic resonance imaging (fMRI). In a randomized controlled trial, abstinent alcohol-dependent patients were randomly assigned to a CET group (n = 15) or a control group (n = 15). All patients underwent an extended detoxification treatment comprising medically supervised detoxification, health education, and supportive therapy. The CET patients additionally received nine CET sessions over 3 weeks, exposing the patient to his/her preferred alcoholic beverage. Cue-induced fMRI activation to alcohol cues was measured at pretreatment and posttreatment. Compared with pretreatment, fMRI cue-reactivity reduction was greater in the CET relative to the control group, especially in the anterior cingulate gyrus and the insula, as well as limbic and frontal regions. Before treatment, increased cue-induced fMRI activation was found in limbic and reward-related brain regions and in visual areas. After treatment, the CET group showed less activation than the control group in the left ventral striatum. The study provides first evidence that an exposure-based psychotherapeutic intervention in the treatment of alcoholism impacts on brain areas relevant for addiction memory and attentional focus to alcohol-associated cues and affects mesocorticolimbic reward pathways suggested to be pathophysiologically involved in addiction. Copyright © 2011 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.
Bernard, Paquito; Ninot, Gregory; Cyprien, Fabienne; Courtet, Philippe; Guillaume, Sebastien; Georgescu, Vera; Picot, Marie-Christine; Taylor, Adrian; Quantin, Xavier
2015-01-01
Despite various strategies to help smokers with depressive disorders to quit, the smoking relapse rate remains high. The purpose of this pilot study was to estimate the effects of adding an exercise and counseling intervention to standard smoking cessation treatment for smokers with depressive disorders. We hypothesized that the exercise and counseling intervention would lead to improved abstinence, reduced depressive symptoms, and increased physical activity. Seventy smokers with current depressive disorders were randomly assigned to standard smoking cessation treatment plus exercise and counseling (n = 35) or standard treatment plus a time-to-contact control intervention on health education (n = 35). Both programs involved 10 sessions over 8 weeks. The primary outcome was continuous abstinence since the quit date and was measured at week 8 (end of the intervention) and again at 12-, 24-, and 52-week follow-ups. Nearly 60% of participants were female (n = 41), 38 (52.3%) were single, 37 (52.9%) had education beyond high school, and 32 (45.7%) met criteria for major depressive disorder or dysthymia. Participants in the two treatment conditions differed at baseline only in marital status (χ(2) = 4.28, df = 1, p =.04); and smoking abstinence self-efficacy, t(66) = -2.04, p =.04). The dropout rate did not differ significantly between groups and participants attended 82% and 75% of the intervention and control sessions, respectively. Intention-to-treat analysis showed that, at 12 weeks after the beginning of the intervention, continuous abstinence did not vary significantly between the intervention and control groups: 48.5% versus 28.5%, respectively, ORadj = 0.40, 95% CI [0.12-1.29], p =.12. There were no group differences in depressive symptoms, but the intervention group did outperform the control group on the 6-minute walking test (Mint = 624.84, SD = 8.17, vs. Mcon = 594.13, SD = 8.96, p =.015) and perceived physical control (Mint = 2.84, SD = 0.16, vs. Mcon = 2
Assessing the Generalizability of Randomized Trial Results to Target Populations
Stuart, Elizabeth A.; Bradshaw, Catherine P.; Leaf, Philip J.
2014-01-01
Recent years have seen increasing interest in and attention to evidence-based practices, where the “evidence” generally comes from well-conducted randomized trials. However, while those trials yield accurate estimates of the effect of the intervention for the participants in the trial (known as “internal validity”), they do not always yield relevant information about the effects in a particular target population (known as “external validity”). This may be due to a lack of specification of a target population when designing the trial, difficulties recruiting a sample that is representative of a pre-specified target population, or to interest in considering a target population somewhat different from the population directly targeted by the trial. This paper first provides an overview of existing design and analysis methods for assessing and enhancing the ability of a randomized trial to estimate treatment effects in a target population. It then provides a case study using one particular method, which weights the subjects in a randomized trial to match the population on a set of observed characteristics. The case study uses data from a randomized trial of School-wide Positive Behavioral Interventions and Supports (PBIS); our interest is in generalizing the results to the state of Maryland. In the case of PBIS, after weighting, estimated effects in the target population were similar to those observed in the randomized trial. The paper illustrates that statistical methods can be used to assess and enhance the external validity of randomized trials, making the results more applicable to policy and clinical questions. However, there are also many open research questions; future research should focus on questions of treatment effect heterogeneity and further developing these methods for enhancing external validity. Researchers should think carefully about the external validity of randomized trials and be cautious about extrapolating results to specific
Assessing the generalizability of randomized trial results to target populations.
Stuart, Elizabeth A; Bradshaw, Catherine P; Leaf, Philip J
2015-04-01
Recent years have seen increasing interest in and attention to evidence-based practices, where the "evidence" generally comes from well-conducted randomized trials. However, while those trials yield accurate estimates of the effect of the intervention for the participants in the trial (known as "internal validity"), they do not always yield relevant information about the effects in a particular target population (known as "external validity"). This may be due to a lack of specification of a target population when designing the trial, difficulties recruiting a sample that is representative of a prespecified target population, or to interest in considering a target population somewhat different from the population directly targeted by the trial. This paper first provides an overview of existing design and analysis methods for assessing and enhancing the ability of a randomized trial to estimate treatment effects in a target population. It then provides a case study using one particular method, which weights the subjects in a randomized trial to match the population on a set of observed characteristics. The case study uses data from a randomized trial of school-wide positive behavioral interventions and supports (PBIS); our interest is in generalizing the results to the state of Maryland. In the case of PBIS, after weighting, estimated effects in the target population were similar to those observed in the randomized trial. The paper illustrates that statistical methods can be used to assess and enhance the external validity of randomized trials, making the results more applicable to policy and clinical questions. However, there are also many open research questions; future research should focus on questions of treatment effect heterogeneity and further developing these methods for enhancing external validity. Researchers should think carefully about the external validity of randomized trials and be cautious about extrapolating results to specific populations unless
A multiple imputation strategy for sequential multiple assignment randomized trials
Shortreed, Susan M.; Laber, Eric; Stroup, T. Scott; Pineau, Joelle; Murphy, Susan A.
2014-01-01
Sequential multiple assignment randomized trials (SMARTs) are increasingly being used to inform clinical and intervention science. In a SMART, each patient is repeatedly randomized over time. Each randomization occurs at a critical decision point in the treatment course. These critical decision points often correspond to milestones in the disease process or other changes in a patient’s health status. Thus, the timing and number of randomizations may vary across patients and depend on evolving patient-specific information. This presents unique challenges when analyzing data from a SMART in the presence of missing data. This paper presents the first comprehensive discussion of missing data issues typical of SMART studies: we describe five specific challenges, and propose a flexible imputation strategy to facilitate valid statistical estimation and inference using incomplete data from a SMART. To illustrate these contributions, we consider data from the Clinical Antipsychotic Trial of Intervention and Effectiveness (CATIE), one of the most well-known SMARTs to date. PMID:24919867
O’Malley, Stephanie S.; Robin, Robert W.; Levenson, Aryeh L.; GreyWolf, Iva; Chance, Lawrence E.; Hodgkinson, Colin A.; Romano, Denise; Robinson, Jane; Meandzija, Boris; Stillner, Verner; Wu, Ran; Goldman, David
2009-01-01
Background Access to specialty alcoholism treatment in rural environments is limited and new treatment approaches are needed. The objective was to evaluate the efficacy of naltrexone alone and in combination with sertraline among Alaska Natives and other Alaskans living in rural settings. An exploratory aim examined whether the Asn40Asp polymorphism of the μ-opioid receptor gene (OPRMI) predicted response to naltrexone, as had been reported in Caucasians. Methods Randomized, controlled trial enrolling 101 Alaskans with alcohol dependence, including 68 American Indians/Alaska Natives. Participants received 16 weeks of either (1) placebo (placebo naltrexone + placebo sertraline), (2) naltrexone monotherapy (50 mg naltrexone + sertraline placebo) and (3) naltrexone + sertraline (100 mg) plus nine sessions of medical management and supportive advice. Primary outcomes included Time to First Heavy Drinking Day and Total Abstinence. Results Naltrexone monotherapy demonstrated significantly higher total abstinence (35%) compared with placebo (12%, p = 0027) and longer, but not statistically different, Time to First Heavy Drinking Day (p = 0.093). On secondary measures, naltrexone compared with placebo demonstrated significant improvements in percent days abstinent (p = 0.024) and drinking-related consequences (p = 0.02). Combined sertraline and naltrexone did not differ from naltrexone alone. The pattern of findings was generally similar for the American Indian/Alaska Native sub-sample. Naltrexone treatment response was significant within the group of 75 individuals who were homozygous for OPRM1 Asn40 allele. There was a small number of Asp40 carriers, precluding statistical testing of the effect of this allele on response. Conclusions Naltrexone can be used effectively to treat alcoholism in remote and rural communities, with evidence of benefit for American Indians and Alaska Natives. New models of care incorporating pharmacotherapy could reduce important health
Caprioli, Daniele; Venniro, Marco; Zeric, Tamara; Li, Xuan; Adhikary, Sweta; Madangopal, Rajtarun; Marchant, Nathan J; Lucantonio, Federica; Schoenbaum, Geoffrey; Bossert, Jennifer M; Shaham, Yavin
2015-10-01
Cue-induced methamphetamine craving increases after prolonged forced (experimenter-imposed) abstinence from the drug (incubation of methamphetamine craving). Here, we determined whether this incubation phenomenon would occur under conditions that promote voluntary (self-imposed) abstinence. We also determined the effect of the novel metabotropic glutamate receptor 2 positive allosteric modulator, AZD8529, on incubation of methamphetamine craving after forced or voluntary abstinence. We trained rats to self-administer palatable food (6 sessions) and then to self-administer methamphetamine under two conditions: 12 sessions (9 hours/day) or 50 sessions (3 hours/day). We then assessed cue-induced methamphetamine seeking in extinction tests after 1 or 21 abstinence days. Between tests, the rats underwent either forced abstinence (no access to the food- or drug-paired levers) or voluntary abstinence (achieved via a discrete choice procedure between methamphetamine and palatable food; 20 trials per day) for 19 days. We also determined the effect of subcutaneous injections of AZD8529 (20 and 40 mg/kg) on cue-induced methamphetamine seeking 1 day or 21 days after forced or voluntary abstinence. Under both training and abstinence conditions, cue-induced methamphetamine seeking in the extinction tests was higher after 21 abstinence days than after 1 day (incubation of methamphetamine craving). AZD8529 decreased cue-induced methamphetamine seeking on day 21 but not day 1 of forced or voluntary abstinence. We introduce a novel animal model to study incubation of drug craving and cue-induced drug seeking after prolonged voluntary abstinence, mimicking the human condition of relapse after successful contingency management treatment. Our data suggest that positive allosteric modulators of metabotropic glutamate receptor 2 should be considered for relapse prevention. Published by Elsevier Inc.
Breastfeeding and abstinence among the Yoruba.
Dow, T E
1977-08-01
Contemporary patterns of breastfeeding and postpartum abstinence among the Yoruba of Nigera are examined. Quite extensive periods of postpartum abstinence are still observed by most rural and poorer urban women to prolong breastfeeding and increase child survivorship. Differentials in duration of breastfeeding and abstinence relate to both socioeconomic factors and age, suggesting the likelihood of large future reductions. Implications for family planning prospects and policies are noted.
Effectiveness of web-based tailored smoking cessation advice reports (iQuit): a randomized trial.
Mason, Dan; Gilbert, Hazel; Sutton, Stephen
2012-12-01
To determine whether web-based tailored cessation advice, based on social cognitive theory and the perspectives on change model, was more effective in aiding a quit attempt than broadly similar web-based advice that was not tailored. Participants were allocated randomly to one of two groups, to receive either a cessation advice report and progress report that were tailored to individual-level characteristics or a cessation advice report that presented standardized (non-tailored) content. Tailoring was based on smoking-related beliefs, personal characteristics and smoking patterns, self-efficacy and outcome expectations. Participant enrolment and baseline assessments were conducted remotely online via the study website, with the advice reports presented by the same website. Participants (n = 1758) were visitors to the QUIT website who were based in the United Kingdom, aged 18 years or over and who smoked cigarettes or hand-rolled tobacco. Follow-up assessments were made at 6 months by telephone interview. The primary outcome measure was self-reported 3 months prolonged abstinence, and secondary outcomes were 1 month prolonged abstinence, 7-day and 24-hour point prevalence abstinence. The intervention group did not differ from the control group on the primary outcome (9.1% versus 9.3%; odds ratio = 1.02 95% confidence interval 0.73-1.42) or on any of the secondary outcomes. Intervention participants gave more positive evaluations of the materials than control participants. A web-based intervention that tailored content according to smoking-related beliefs, personal characteristics and smoking patterns, self-efficacy and outcome expectations, was not more effective than web-based materials presenting broadly similar non-tailored information. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.
Farris, Samantha G; DiBello, Angelo M; Heggeness, Luke F; Reitzel, Lorraine R; Vidrine, Damon J; Schmidt, Norman B; Zvolensky, Michael J
2016-06-01
Smoking-specific experiential avoidance is related to the maintenance of cigarette smoking. However, it is unclear whether sustained smoking abstinence is associated with subsequent reductions in smoking-specific experiential avoidance. Daily smokers (n = 149) underwent a cessation attempt in the context of a 4-session smoking cessation treatment trial. Participants provided biochemical verification of smoking status at 1 week, 2 weeks, and 1 Month post-quit day. Smoking-specific experiential avoidance was assessed per the Avoidance and Inflexibility Scale (AIS) - the total score and two factor scores were examined at 1 Month post-quit day as a function of abstinence status. Two path models were conducted and included participant sex, treatment condition, and pre-cessation nicotine dependence, smoking-specific experiential avoidance, and presence of emotional disorders as covariates. After adjusting for covariates, sustained smoking abstinence was associated with a reduction in the AIS total score at Month 1 post-quit (β = -.45, p < .001). Sustained smoking abstinence was associated with reductions across both facets of experiential avoidance -- smoking-related thoughts and feelings (β = -.44, p < .001) and internal bodily sensations (β = -.41, p < .001). Biochemical verification of smoking status was confirmed only at three time points post-quit day, and continued abstinence throughout the one-month post-quitting period is not fully known. Sustained smoking abstinence may contribute to reductions in smoking-specific experiential avoidance. Findings add to the research documenting the relevance of experiential avoidance in various processes of smoking (including smoking abstinence). Copyright © 2015 Elsevier Ltd. All rights reserved.
Power Calculations for Moderators in Multi-Site Cluster Randomized Trials
ERIC Educational Resources Information Center
Spybrook, Jessaca; Kelcey, Ben; Dong, Nianbo
2016-01-01
Cluster randomized trials (CRTs), or studies in which intact groups of individuals are randomly assigned to a condition, are becoming more common in evaluation studies of educational programs. A specific type of CRT in which clusters are randomly assigned to treatment within blocks or sites, known as multisite cluster randomized trials (MSCRTs),…
Santos, GM; Das, M; Santos, DM; Huffaker, S; Matheson, T; Gasper, J; Vittinghoff, E; Colfax, GN
2012-01-01
Aims To test aripiprazole for efficacy in decreasing use in methamphetamine-dependent adults, compared to placebo. Design Participants were randomized to receive 12 weeks of aripiprazole or placebo, with a 3 month follow-up and a platform of weekly 30-minute substance abuse counseling. Setting The trial was conducted from January 2009 to March 2012 at the San Francisco Department of Public Health. Participants Ninety actively-using, methamphetamine-dependent, sexually active, adults were recruited from community venues. Measurements The primary outcome was regression estimated reductions in weekly methamphetamine-positive urines. Secondary outcomes were study medication adherence (by self-report and medication event monitoring systems [MEMS]), sexual risk behavior, and abstinence from methamphetamine. Findings Participant mean age was 38.7 years, 87.8% were male, 50.0% white, 18.9% African-American, and 16.7% Latino. Eighty-three percent of follow-up visits and final visits were completed. By intent-to-treat, participants assigned to aripiprazole had similar reductions in methamphetamine-positive urines as participants assigned to placebo (RR 0.88, 95% CI 0.66–1.19, P=0.41). Urine positivity declined from 73%(33/45 participants) to 45%(18/40) in the placebo arm, and from 77% (34/44) to 44% (20/35) in the aripiprazole arm. Adherence by MEMS and self-report was 42% and 74%, respectively, with no significant difference between arms (MEMS P=0.31; self-report P=0.17). Most sexual risk behaviors declined similarly among participants in both arms (all P>0.05). There were no serious adverse events related to study drug, although participants randomized to aripiprazole reported more akathisia, fatigue, and drowsiness (P<0.05). Conclusion Compared with placebo, aripiprazole did not significantly reduce methamphetamine use among actively-using, dependent adults. PMID:23186131
Litten, Raye Z.; Castle, I-Jen P.; Falk, Daniel; Ryan, Megan; Fertig, Joanne; Chen, Chiung M.; Yi, Hsiao-ye
2013-01-01
Background The placebo effect often undermines efforts to determine treatment effectiveness in clinical trials. A significant placebo response occurs in alcohol trials, but it is not well understood. The purpose of this study was to characterize the placebo response across multiple naltrexone and acamprosate studies. Methods Fifty-one trials, 3 with a naltrexone and an acamprosate arm, 31 with at least 1 naltrexone arm, and 17 with at least 1 acamprosate arm, were identified from Cochrane reviews and PubMed search. To be included in this study, patients had to be at least 18 years old, abstinent from alcohol before randomization, and meet a diagnosis of alcohol dependence. Pearson correlation coefficients (rp) and simple linear regression were used to describe the strength of linear relationships between placebo response and treatment effect size. Spearman’s rank correlation coefficients (rs) were used to examine the strength of associations between study characteristics and placebo response. Results For the end-point measures of percent days abstinent and total abstinence, a negative relationship was evident between placebo response and treatment effect size in the naltrexone trials (rp = −0.55, p < 0.01 and rp = −0.20, p = 0.35, respectively) as well as in the acamprosate trials (rp = −0.45, p = 0.09 and rp = −0.56, p = 0.01, respectively). The placebo response for percent days abstinent was negatively correlated with mean age of participants (rs = −0.42, p = 0.05) across naltrexone trials and positively correlated with publication year (rs = 0.57, p = 0.03) across acamprosate trials. However, these two study characteristics were not significantly correlated with treatment effect size. Conclusion The placebo response varied considerably across trials and was negatively correlated with the treatment effect size. Additional studies are required to fully understand the complex nature of the placebo response and to evaluate approaches to minimize its
Li, William H. C.; Wang, M. P.; LAM, T. H.; Cheung, Yannes T. Y.; Cheung, Derek Y. T.; Suen, Y. N.; Ho, K. Y.; Tan, Kathryn C. B.; CHAN, Sophia S. C.
2017-01-01
The aim of the study was to examine the effects of a brief stage-matched smoking cessation intervention group compared with a control group (with usual care) in type 2 diabetes mellitus patients who smoked by randomized controlled trial. There were 557 patients, randomized either into the intervention group (n = 283) who received brief (20- minute) individualized face-to-face counseling by trained nurses and a diabetes mellitus-specific leaflet, or a control group (n = 274) who received standard care. Patient follow-ups were at 1 week, 1 month, 3 months, 6 months, and 12 months via telephone, and assessment of smoking status from 2012 to 2014. Patients smoked an average of 14 cigarettes per day for more than 37 years, and more than 70% were in the precontemplation stage of quitting. The primary outcome showed that both the intervention and control groups had similar 7-day point-prevalence smoking abstinence (9.2% vs. 13.9%; p = 0.08). The secondary outcome showed that HbA1c levels with 7.95% [63 mmol/mol] vs. 8.05% [64 mmol/mol], p = 0.49 at 12 months, respectively. There was no evidence for effectiveness in promoting the brief stage-matched smoking cessation or improving glycemic control in smokers with type 2 diabetes mellitus, particularly those in the pre-contemplation stage. PMID:28378764
Fröbert, Ole; Götberg, Matthias; Angerås, Oskar; Jonasson, Lena; Erlinge, David; Engstrøm, Thomas; Persson, Jonas; Jensen, Svend E; Omerovic, Elmir; James, Stefan K; Lagerqvist, Bo; Nilsson, Johan; Kåregren, Amra; Moer, Rasmus; Yang, Cao; Agus, David B; Erglis, Andrejs; Jensen, Lisette O; Jakobsen, Lars; Christiansen, Evald H; Pernow, John
2017-07-01
Registry studies and case-control studies have demonstrated that the risk of acute myocardial infarction (AMI) is increased following influenza infection. Small randomized trials, underpowered for clinical end points, indicate that future cardiovascular events can be reduced following influenza vaccination in patients with established cardiovascular disease. Influenza vaccination is recommended by international guidelines for patients with cardiovascular disease, but uptake is varying and vaccination is rarely prioritized during hospitalization for AMI. The Influenza vaccination After Myocardial Infarction (IAMI) trial is a double-blind, multicenter, prospective, registry-based, randomized, placebo-controlled, clinical trial. A total of 4,400 patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI undergoing coronary angiography will randomly be assigned either to in-hospital influenza vaccination or to placebo. Baseline information is collected from national heart disease registries, and follow-up will be performed using both registries and a structured telephone interview. The primary end point is a composite of time to all-cause death, a new AMI, or stent thrombosis at 1 year. The IAMI trial is the largest randomized trial to date to evaluate the effect of in-hospital influenza vaccination on death and cardiovascular outcomes in patients with STEMI or non-STEMI. The trial is expected to provide highly relevant clinical data on the efficacy of influenza vaccine as secondary prevention after AMI. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.
Morley, Kirsten C; Baillie, Andrew; Sannibale, Claudia; Teesson, Maree; Haber, Paul S
2013-11-19
A major barrier to successful treatment in alcohol dependence is psychiatric comorbidity. During treatment, the time to relapse is shorter, the drop-out rate is increased, and long-term alcohol consumption is greater for those with comorbid major depression or anxiety disorder than those with an alcohol use disorder with no comorbid mental disorder. The treatment of alcohol dependence and psychological disorders is often the responsibility of different services, and this can hinder the treatment process. Accordingly, there is a need for an effective integrated treatment for alcohol dependence and comorbid anxiety and/or depression. We aim to assess the effectiveness of a specialized, integrated intervention for alcohol dependence with comorbid anxiety and/or mood disorder using a randomized design in an outpatient hospital setting. Following a three-week stabilization period (abstinence or significantly reduced consumption), participants will undergo complete formal assessment for anxiety and depression. Those patients with a diagnosis of an anxiety and/or depressive disorder will be randomized to either 1) integrated intervention (cognitive behavioral therapy) for alcohol, anxiety, and/or depression; or 2) usual counseling care for alcohol problems. Patients will then be followed up at weeks 12, 16, and 24. The primary outcome measure is alcohol consumption (total abstinence, time to lapse, and time to relapse). Secondary outcome measures include changes in alcohol dependence severity, depression, or anxiety symptoms and changes in clinician-rated severity of anxiety and depression. The study findings will have potential implications for clinical practice by evaluating the implementation of specialized integrated treatment for comorbid anxiety and/or depression in an alcohol outpatient service. ClinicalTrials.gov Identifier: NCT01941693.
A random walk model for evaluating clinical trials involving serial observations.
Hopper, J L; Young, G P
1988-05-01
For clinical trials where the variable of interest is ordered and categorical (for example, disease severity, symptom scale), and where measurements are taken at intervals, it might be possible to achieve a greater discrimination between the efficacy of treatments by modelling each patient's progress as a stochastic process. The random walk is a simple, easily interpreted model that can be fitted by maximum likelihood using a maximization routine with inference based on standard likelihood theory. In general the model can allow for randomly censored data, incorporates measured prognostic factors, and inference is conditional on the (possibly non-random) allocation of patients. Tests of fit and of model assumptions are proposed, and application to two therapeutic trials of gastroenterological disorders are presented. The model gave measures of the rate of, and variability in, improvement for patients under different treatments. A small simulation study suggested that the model is more powerful than considering the difference between initial and final scores, even when applied to data generated by a mechanism other than the random walk model assumed in the analysis. It thus provides a useful additional statistical method for evaluating clinical trials.
[Smoking abstinence rate and its associated factors between abrupt and gradual smoking cessation].
Hao, R; Zhou, J P; Ni, L; Li, Q Y; Shi, G C
2017-12-12
Objective: To analyze and compare the abstinence rate of smoking quitting methods and its associated factors between abrupt and gradual smoking cessation in smokers with drug-based therapy. Methods: A prospective clinical study was conducted in patients undergoing quitting smoking intervention in Ruijin Hospital smoking cessation clinic between June 2013 and May 2016. All the subjects were randomized in a 1∶1 ratio into the abrupt smoking cessation group (smoking as usual over 3 weeks before a planned quit day, and then stopping smoking abruptly) and the gradual smoking cessation group (gradually reducing tobacco use over 3 weeks before a planned quit day, and then stopping smoking totally). The primary outcome was the complete abstinence rate, and the secondary outcomes included 1-month, 3-month and 6 month 7-day point prevalence of abstinence rates and 3 month sustained abstinence rates. Changes of body weight and drug adverse events were also compared. Results: A total of 314 moderate to severe nicotine-dependent patients were admitted in the study, including 157 patients in the abrupt smoking cessation and 157 patients in the gradual smoking cessation group. Fourteen patients fell off during the follow-up. For the complete abstinence rate, the gradual smoking cessation group was higher than the abrupt smoking cessation group(55.0% vs . 36.9%, χ(2)=9.841, P =0.002) .For 7-d smoking abstinence rate in the 1st, 3rd, 6th month, there was no significant difference between the 2 groups (all P >0.05). As for the 3-month sustained abstinence rate, a higher smoking quitting rate was seen in the gradual smoking cessation group compared to the abrupt smoking cessation group in the 6-month follow-up (17.9% vs .8.7%, χ(2)=5.441, P =0.020). The adverse drug reaction incidence was higher in the abrupt smoking cessation group than the gradual smoking cessation group (Gastrointestinal discomfort: 39.2% vs . 17.7%, χ(2)=12.336, P =0.000; Dreaminess: 40.2% vs . 13.3%, χ(2
Adaptive Designs for Randomized Trials in Public Health
Brown, C. Hendricks; Have, Thomas R. Ten; Jo, Booil; Dagne, Getachew; Wyman, Peter A.; Muthén, Bengt; Gibbons, Robert D.
2009-01-01
In this article, we present a discussion of two general ways in which the traditional randomized trial can be modified or adapted in response to the data being collected. We use the term adaptive design to refer to a trial in which characteristics of the study itself, such as the proportion assigned to active intervention versus control, change during the trial in response to data being collected. The term adaptive sequence of trials refers to a decision-making process that fundamentally informs the conceptualization and conduct of each new trial with the results of previous trials. Our discussion below investigates the utility of these two types of adaptations for public health evaluations. Examples are provided to illustrate how adaptation can be used in practice. From these case studies, we discuss whether such evaluations can or should be analyzed as if they were formal randomized trials, and we discuss practical as well as ethical issues arising in the conduct of these new-generation trials. PMID:19296774
Scott, Christy K; Dennis, Michael L; Gustafson, David H
2017-08-10
Alcohol abuse, other substance use disorders, and risk behaviors associated with the human immunodeficiency virus (HIV) represent three of the top 10 modifiable causes of mortality in the US. Despite evidence that continuing care is effective in sustaining recovery from substance use disorders and associated behaviors, patients rarely receive it. Smartphone applications (apps) have been effective in delivering continuing care to patients almost anywhere and anytime. This study tests the effectiveness of two components of such apps: ongoing self-monitoring through Ecological Momentary Assessments (EMAs) and immediate recovery support through Ecological Momentary Interventions (EMIs). The target population, adults enrolled in substance use disorder treatment (n = 400), are being recruited from treatment centers in Chicago and randomly assigned to one of four conditions upon discharge in a 2 × 2 factorial design. Participants receive (1) EMAs only, (2) EMIs only, (3) combined EMAs + EMIs, or (4) a control condition without EMA or EMI for 6 months. People in the experimental conditions receive smartphones with the apps (EMA and/or EMI) specific to their condition. Phones alert participants in the EMA and EMA + EMI conditions at five random times per day and present participants with questions about people, places, activities, and feelings that they experienced in the past 30 min and whether these factors make them want to use substances, support their recovery, or have no impact. Those in the EMI and EMA + EMI conditions have continual access to a suite of support services. In the EMA + EMI condition, participants are prompted to use the EMI(s) when responses to the EMA(s) indicate risk. All groups have access to recovery support as usual. The primary outcome is days of abstinence from alcohol and other drugs. Secondary outcomes are number of HIV risk behaviors and whether abstinence mediates the effects of EMA, EMI, or EMA + EMI on HIV
Key Items to Get Right When Conducting a Randomized Controlled Trial in Education
ERIC Educational Resources Information Center
Coalition for Evidence-Based Policy, 2005
2005-01-01
This is a checklist of key items to get right when conducting a randomized controlled trial to evaluate an educational program or practice ("intervention"). It is intended as a practical resource for researchers and sponsors of research, describing items that are often critical to the success of a randomized controlled trial. A significant…
ERIC Educational Resources Information Center
Hagen, Åste M.; Melby-Lervåg, Monica; Lervåg, Arne
2017-01-01
Background: Children with language comprehension difficulties are at risk of educational and social problems, which in turn impede employment prospects in adulthood. However, few randomized trials have examined how such problems can be ameliorated during the preschool years. Methods: We conducted a cluster randomized trial in 148 preschool…
Exercise to Enhance Smoking Cessation: the Getting Physical on Cigarette Randomized Control Trial.
Prapavessis, Harry; De Jesus, Stefanie; Fitzgeorge, Lindsay; Faulkner, Guy; Maddison, Ralph; Batten, Sandra
2016-06-01
Exercise has been proposed as a useful smoking cessation aid. The purpose of the present study is to determine the effect of an exercise-aided smoking cessation intervention program, with built-in maintenance components, on post-intervention 14-, 26- and 56-week cessation rates. Female cigarette smokers (n = 413) participating in a supervised exercise and nicotine replacement therapy (NRT) smoking cessation program were randomized to one of four conditions: exercise + smoking cessation maintenance, exercise maintenance + contact control, smoking cessation maintenance + contact control or contact control. The primary outcome was continuous smoking abstinence. Abstinence differences were found between the exercise and equal contact non-exercise maintenance groups at weeks 14 (57 vs 43 %), 26 (27 vs 21 %) and 56 (26 vs 23.5 %), respectively. Only the week 14 difference approached significance, p = 0.08. An exercise-aided NRT smoking cessation program with built-in maintenance components enhances post-intervention cessation rates at week 14 but not at weeks 26 and 56.
The Design of Cluster Randomized Trials with Random Cross-Classifications
ERIC Educational Resources Information Center
Moerbeek, Mirjam; Safarkhani, Maryam
2018-01-01
Data from cluster randomized trials do not always have a pure hierarchical structure. For instance, students are nested within schools that may be crossed by neighborhoods, and soldiers are nested within army units that may be crossed by mental health-care professionals. It is important that the random cross-classification is taken into account…
Chan, Ching Han Helen; Lai, Chi-Keung Jonah; Chan, Wai Fung Vivian; Wang, Man Ping; Li, Ho Cheung William; Chan, Sophia Siu Chee; Lam, Tai-Hing
2015-01-01
Background Quit attempters often have episodes of smoking relapse before they eventually quit. Interactive text messaging through mobile phones has been shown to increase abstinence. This service can be potentially applied on the platform of a social networking service to help quitters maintain abstinence. Objective Our aim was to determine if the group discussion and reminders via the WhatsApp or Facebook social group were effective to prevent smoking relapse in quitters who had stopped smoking recently. Methods This was a single-blinded, parallel, 3-arm pilot cluster randomized controlled trial allocating recent quitters, who had completed an 8-week treatment and reported abstinence for at least 7 days, to WhatsApp (n=42), Facebook (n=40), and a control group (n=54). The 2 intervention groups participated in a 2-month online group discussion with either WhatsApp or Facebook moderated by a trained smoking cessation counselor and received a self-help booklet on smoking cessation. The control group only received the booklet. The primary outcome was the 2- and 6-month relapse rates, defined as the proportion of participants who smoked at least 5 cigarettes in 3 consecutive days. Results Fewer participants in the WhatsApp group (17%, 7/42) reported relapse than the control group (42.6%, 23/54) at 2-month (OR 0.27, 95% CI 0.10-0.71) and 6-month (40.5%, 17/42 vs 61.1%, 33/54; OR 0.43, 95% CI 0.19-0.99) follow-ups. The Facebook group (30.0%, 12/40) had an insignificantly lower relapse rate than the control group (42.6%, 23/54) at 2-month (OR 0.58, 95% CI 0.24-1.37) and 6-month (52.5%, 13/40 vs 61.1%, 33/54; OR 0.70, 95% CI 0.31-1.61) follow-ups. The WhatsApp social groups had more moderators’ posts (median 60, IQR 25 vs median 32, IQR 7; P=.05) and participants’ posts (median 35, IQR 50 vs median 6, IQR 9; P=.07) than their Facebook counterparts, but the difference was insignificant. Conclusions The intervention via the WhatsApp social group was effective in reducing
Group hypnosis vs. relaxation for smoking cessation in adults: a cluster-randomised controlled trial
2013-01-01
Background Despite the popularity of hypnotherapy for smoking cessation, the efficacy of this method is unclear. We aimed to investigate the efficacy of a single-session of group hypnotherapy for smoking cessation compared to relaxation in Swiss adult smokers. Methods This was a cluster-randomised, parallel-group, controlled trial. A single session of hypnosis or relaxation for smoking cessation was delivered to groups of smokers (median size = 11). Participants were 223 smokers consuming ≥ 5 cigarettes per day, willing to quit and not using cessation aids (47.1% females, M = 37.5 years [SD = 11.8], 86.1% Swiss). Nicotine withdrawal, smoking abstinence self-efficacy, and adverse reactions were assessed at a 2-week follow-up. The main outcome, self-reported 30-day point prevalence of smoking abstinence, was assessed at a 6-month follow up. Abstinence was validated through salivary analysis. Secondary outcomes included number of cigarettes smoked per day, smoking abstinence self-efficacy, and nicotine withdrawal. Results At the 6-month follow up, 14.7% in the hypnosis group and 17.8% in the relaxation group were abstinent. The intervention had no effect on smoking status (p = .73) or on the number of cigarettes smoked per day (p = .56). Smoking abstinence self-efficacy did not differ between the interventions (p = .14) at the 2-week follow-up, but non-smokers in the hypnosis group experienced reduced withdrawal (p = .02). Both interventions produced few adverse reactions (p = .81). Conclusions A single session of group hypnotherapy does not appear to be more effective for smoking cessation than a group relaxation session. Trial registration Current Controlled Trials ISRCTN72839675. PMID:24365274
Zhang, Jingwen; Jemmott, John B; Jemmott, Loretta Sweet
2015-12-01
This secondary data analysis sought to determine what mediated reductions in self-reported sexual initiation over the 24-month postintervention period in early adolescents who received "Promoting Health among Teens," a theory-based, abstinence-only intervention (Jemmott, Jemmott, & Fong, 2010). African American Grade 6 and 7 students at inner-city public middle schools were randomized to 1 of 5 interventions grounded in social-cognitive theory and the theory of reasoned action: 8-hr abstinence-only targeting reduced sexual intercourse; 8-hr safer-sex-only targeting increased condom use; 8-hr and 12-hr comprehensive interventions targeting sexual intercourse and condom use; 8-hr control intervention targeting physical activity and diet. Primary outcome was self-report of vaginal intercourse by 24 months postintervention. Potential mediators, assessed immediately postintervention, were theory-of-reasoned-action variables, including behavioral beliefs about positive consequences of abstinence and negative consequences of sex, intention to have sex, normative beliefs about sex, and HIV and sexually transmitted infection (STI) knowledge. We tested single and serial mediation models using the product-of-coefficients approach. Of 509 students reporting never having vaginal intercourse at baseline (324 girls and 185 boys; mean age = 11.8 years, SD = 0.8), 500 or 98.2% were included in serial mediation analyses. Consistent with the theory of reasoned action, the abstinence-only intervention increased positive behavioral beliefs about abstinence, which reduced intention to have sex, which in turn reduced sexual initiation. Negative behavioral beliefs about sex, normative beliefs about sex, and HIV/STI knowledge were not mediators. Abstinence-only interventions should stress the gains to be realized from abstinence rather than the deleterious consequences of sexual involvement. (c) 2015 APA, all rights reserved).
Antibiotics for human toxoplasmosis: a systematic review of randomized trials
Rajapakse, Senaka; Chrishan Shivanthan, Mitrakrishnan; Samaranayake, Nilakshi; Rodrigo, Chaturaka; Deepika Fernando, Sumadhya
2013-01-01
The efficacy of different treatment regimens in clinical syndromes of toxoplasmosis were assessed by conducting a systematic review of published randomized clinical trials through extensive searches in MEDLINE, EMBASE, and SCOPUS with no date limits, as well as manual review of journals. Outcome measures varied depending on the clinical entity of toxoplasmosis. Risk of bias was evaluated and quality of evidence was graded. Fourteen randomized trials were included of which one was a non-comparative study. One well-designed trial showed that trimethoprim-sulphamethoxazole was more effective than placebo for clinical recovery of toxoplasmic lymphadenopathy in immunocompetent hosts. For toxoplasmic encephalopathy, efficacy of pyrimethamine+sulphadiazine and trimethoprim+sulphamethoxazole were similar, whereas pyrimethamine+sulphadiazine versus pyrimathamine+clindamycin showed no difference, irrespective of the outcome. Intravitreal clindamycin+dexamethasone and conventional treatment with oral pyrimethamine+sulphadiazine had similar efficacy with regard to all outcome measures in ocular toxoplasmosis, and intravitreal therapy was found to be safe. Adverse effects seemed more common with pyrimethamine+sulphadiazine. Most trials for encephalitis and ocular manifestations had a high risk of bias and were of poor methodological quality. There were no trials evaluating drugs for toxoplasmosis in pregnancy, or for congenital toxoplasmosis. Pyrimethamine+sulphadiazine is an effective therapy for treatment of toxoplasmic encephalitis; trimethoprim+sulphamethoxazole and pyrimethamine+clindamycin are possible alternatives. Treatment with either oral or intravitreal antibiotics seems reasonable for ocular toxoplasmosis. Overall, trial evidence for the efficacy of these drugs for toxoplasmosis is poor, and further well-designed trials are needed. PMID:23816507
Sumner, Walton; Walker, Mark S; Highstein, Gabrielle R; Fischer, Irene; Yan, Yan; McQueen, Amy; Fisher, Edwin B
2016-07-11
Telephone quitlines can help employees quit smoking. Quitlines typically use directive coaching, but nondirective, flexible coaching is an alternative. Call-2-Quit used a worksite-sponsored quitline to compare directive and nondirective coaching modes, and evaluated employee race and income as potential moderators. An unblinded randomized controlled trial compared directive and nondirective telephone coaching by trained laypersons. Participants were smoking employees and spouses recruited through workplace smoking cessation campaigns in a hospital system and affiliated medical school. Coaches were four non-medical women trained to use both coaching modes. Participants were randomized by family to coaching mode. Participants received up to 7 calls from coaches who used computer assisted telephone interview software to track topics and time. Outcomes were reported smoking abstinence for 7 days at last contact, 6 or 12 months after coaching began. Both worksites implemented new tobacco control policies during the study. Most participants responded to an insurance incentive introduced at the hospital. Call-2-Quit coached 518 participants: 22 % were African-American; 45 % had incomes below $30,000. Income, race, and intervention did not affect coaching completion rates. Cessation rates were comparable with directive and nondirective coaching (26 % versus 30 % quit, NS). A full factorial logistic regression model identified above median income (odds ratio = 1.8, p = 0.02), especially among African Americans (p = 0.04), and recent quit attempts (OR = 1.6, p = 0.03) as predictors of cessation. Nondirective coaching was associated with high cessation rates among subgroups of smokers reporting income above the median, recent quit attempts, or use of alternative therapies. Waiting up to 4 weeks to start coaching did not affect cessation. Of 41 highly addicted or depressed smokers who had never quit more than 30 days, none quit. Nondirective
Dunn, Kelly E; Fingerhood, Michael; Wong, Conrad J; Svikis, Dace S; Nuzzo, Paul; Silverman, Kenneth
2014-02-01
Employment-based reinforcement interventions have been used to promote abstinence from drugs among chronically unemployed injection drug users. The current study used an employment-based reinforcement intervention to promote opioid and cocaine abstinence among opioid and/or cocaine-dependent, HIV-positive participants who had recently completed a brief inpatient detoxification. Participants (n = 46) were randomly assigned to an abstinence and work group that was required to provide negative urine samples in order to enter the workplace and to earn incentives for work (n = 16), a work-only group that was permitted to enter the workplace and to earn incentives independent of drug use (n = 15), and a no-voucher control group that did not receive any incentives for working (n = 15) over a 26-week period. The primary outcome was urinalysis-confirmed opioid, cocaine, and combined opioid/cocaine abstinence. Participants were 78% male and 89% African American. Results showed no significant between-groups differences in urinalysis-verified drug abstinence or HIV risk behaviors during the 6-month intervention. The work-only group had significantly greater workplace attendance, and worked more minutes per day when compared to the no-voucher group. Several features of the study design, including the lack of an induction period, setting the threshold for entering the workplace too high by requiring immediate abstinence from several drugs, and increasing the risk of relapse by providing a brief detoxification that was not supported by any continued pharmacological intervention, likely prevented the workplace from becoming established as a reinforcer that could be used to promote drug abstinence. However, increases in workplace attendance have important implications for adult training programs.
Dunn, Kelly; Fingerhood, Michael; Wong, Conrad J.; Svikis, Dace S.; Nuzzo, Paul; Silverman, Kenneth
2015-01-01
Employment-based reinforcement interventions have been used to promote abstinence from drugs among chronically unemployed injection drug users. The current study utilized an employment-based reinforcement intervention to promote opiate and cocaine abstinence among opioid-dependent, HIV-positive participants who had recently completed a brief inpatient detoxification. Participants (n=46) were randomly assigned to an Abstinence & Work group that was required to provide negative urine samples in order to enter the workplace and earn incentives for work (n=16), a Work Only group that was permitted to enter the workplace and earn incentives independent of drug use (n=15), and a No Voucher control group that did not receive any incentives for working (n=15) over a 26-week period. The primary outcome was urinalysis-confirmed opiate, cocaine, and combined opiate/cocaine abstinence. Participants were 78% male and 89% African American. Results showed no significant between-group differences in urinalysis-verified drug abstinence or HIV risk behaviors during the 6-month intervention. The Work Only group had significantly greater workplace attendance and worked more minutes per day when compared to the No Voucher group. Several features of the study design, including the lack of an induction period, setting the threshold for entering the workplace too high by requiring immediate abstinence from several drugs, and increasing the risk of relapse by providing a brief detoxification that was not supported by any continued pharmacological intervention, likely prevented the workplace from becoming established as a reinforcer that could be used to promote drug abstinence. However, increases in workplace attendance have important implications for adult training programs. PMID:24490712
Abstinence at Successful Discharge in Publicly Funded Addiction Health Services
Guerrero, Erick G.; Kong, Yinfei; Kim, Tina
2016-01-01
Abstinence at successful discharge in substance use disorder treatment is important to reducing relapse rates and increasing long-term recovery from substance use disorders. However, few studies have examined abstinence as an essential component of successful discharge. This study examined rates and correlates of reported abstinence (nonuse of drugs 30 days prior to successful discharge) among clients attending publicly funded treatment in Los Angeles County, California. Finding show that only 36% of clients who were successfully discharged reported abstinence. Black clients were less likely than non-Hispanic Whites to report abstinence at successful discharge. Clients in methadone treatment programs were less likely than outpatient clients to report abstinence, whereas clients referred to treatment through the legal system (Proposition 36) were more likely to report abstinence compared to self-referred clients. Findings underscore the importance of systematic assessment of abstinence in determining successful discharge and provide a basis for further examination of strategies to improve abstinence and reduce relapse. PMID:26882909
Abstinence at Successful Discharge in Publicly Funded Addiction Health Services.
Frimpong, Jemima A; Guerrero, Erick G; Kong, Yinfei; Kim, Tina
2016-10-01
Abstinence at successful discharge in substance use disorder treatment is important to reducing relapse rates and increasing long-term recovery from substance use disorders. However, few studies have examined abstinence as an essential component of successful discharge. This study examined rates and correlates of reported abstinence (nonuse of drugs 30 days prior to successful discharge) among clients attending publicly funded treatment in Los Angeles County, California. Finding show that only 36% of clients who were successfully discharged reported abstinence. Black clients were less likely than non-Hispanic Whites to report abstinence at successful discharge. Clients in methadone treatment programs were less likely than outpatient clients to report abstinence, whereas clients referred to treatment through the legal system (Proposition 36) were more likely to report abstinence compared to self-referred clients. Findings underscore the importance of systematic assessment of abstinence in determining successful discharge and provide a basis for further examination of strategies to improve abstinence and reduce relapse.
ERIC Educational Resources Information Center
Wilson, Kelly L.; Smith, Matthew Lee; Menn, Mindy
2013-01-01
Background: The ways in which adolescents define and view sex, abstinence, and virginity impact the efforts of sexuality educators and sexual health professionals. This study examined terminology used by nonsexually active high school students to define abstinence and virginity and identified words students associate with these terms. Purposes…
Ibudilast may improve attention during early abstinence from methamphetamine.
Birath, J Brandon; Briones, Marisa; Amaya, Stephanie; Shoptaw, Steven; Swanson, Aimee-Noelle; Tsuang, John; Furst, Benjamin; Heinzerling, Keith; Obermeit, Lisa; Maes, Lauryn; McKay, Charles; Wright, Matthew J
2017-09-01
Inattention is a deficit related to instilling abstinence from methamphetamine (MA) dependence. This study aimed to determine whether ibudilast (IB; 50mg bid) improves attentional abilities compared to placebo during early abstinence from MA dependence. Attention was assessed in 11 MA-dependent non-treatment seeking participants in a phase IB safety-interaction trial. The Conners' Continuous Performance Test-II (CPT-II), a measure of sustained attention and response inhibition, was administered at baseline and on day 22, 48h post a MA challenge under placebo (P; n=6) or IB 50mg bid (n=5). Group differences were compared using Mann-Whitney U Tests. Groups were similar at baseline in premorbid intellectual functioning, attention deficit hyperactivity symptom scores, impulsivity ratings, and education level, but differed in age. Demographically corrected T-scores for CPT-II performances were utilized. Although no group differences in sustained attention existed at baseline, at follow-up, the IB group (Mdn=44.4) showed reduced variability in response times compared with the P group (Mdn=69.9), U=0.00, z=-2.74, p=.006, r=.83. The IB group (Mdn=45.8) also gave fewer perseverative responses than the P group (Mdn=67.0), U=2.00, z=-2.50, p=.01, r=.75. No other significant differences were observed. Findings suggest that IB may have a protective effect on sustained attention during early abstinence from MA dependence. This may guide thinking about mechanism of action should IB demonstrate efficacy as a treatment for MA dependence. Copyright © 2017 Elsevier B.V. All rights reserved.
Preconception maternal nutrition: a multi-site randomized controlled trial
2014-01-01
Background Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy. Methods/Study design This is an individually randomized controlled trial of the impact on birth length (primary outcome) of the time at which a maternal nutrition intervention is commenced: Arm 1: ≥ 3 mo preconception vs. Arm 2: 12-14 wk gestation vs. Arm 3: none. 192 (derived from 480) randomized mothers and living offspring in each arm in each of four research sites (Guatemala, India, Pakistan, Democratic Republic of the Congo). The intervention is a daily 20 g lipid-based (118 kcal) multi-micronutient (MMN) supplement. Women randomized to receive this intervention with body mass index (BMI) <20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement. Researchers will visit homes biweekly to deliver intervention and monitor compliance, pregnancy status and morbidity; ensure prenatal and delivery care; and promote breast feeding. The primary outcome is birth length. Secondary outcomes include: fetal length at 12 and 34 wk; incidence of low birth weight (LBW); neonatal/infant anthropometry 0-6 mo of age; infectious disease morbidity; maternal, fetal, newborn, and infant epigenetics; maternal and infant nutritional status; maternal and infant microbiome; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk. The primary analysis will compare birth Length-for-Age Z-score (LAZ) among trial arms (independently for each site, estimated effect size: 0.35). Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites. Discussion Positive results of this trial will support a paradigm shift in attention to nutrition of all females of
Ybarra, Michele L.; Korchmaros, Josephine D.; Prescott, Tonya L.; Birungi, Ruth
2015-01-01
Background One in twenty-five Ugandan adolescents is HIV positive. Purpose Examine the impact of an Internet-based HIV prevention program on Information-Motivation-Behavior Skills Model-related constructs. Methods Three hundred and sixty-six sexually experienced and inexperienced students 12-18+ years-old in Mbarara, Uganda were randomly assigned to: the five-lesson CyberSenga program or treatment-as-usual. Half of the intervention participants were further randomized to a booster session. Assessments were collected at three and six months post-baseline. Results Participants’ HIV-related information improved over time at a greater rate for the intervention groups compared to the control group. Motivation for condom use changed to a greater degree over time for the intervention group – especially those in the intervention+booster group - compared to the control group. Behavioral skills for condom use, and motivation and behavioral skills for abstinence were statistically similar over time for both groups. Conclusions CyberSenga improves HIV preventive information and motivation to use condoms. PMID:25633626
Winskell, Kate; Beres, Laura K.; Hill, Elizabeth; Mbakwem, Benjamin Chigozie; Obyerodhyambo, Oby
2012-01-01
Despite the prominence of abstinence promotion in HIV prevention for young Africans, there is little documentation concerning its reception and interpretation. With the purpose of informing programmatic practice, we examined how young Africans from six countries with contrasting HIV prevalence rates make sense of abstinence. ‘Scenarios from Africa’ scriptwriting contests invite young people to contribute ideas for short films about HIV. Using thematic narrative-based approaches, we analyzed a stratified random sample of 586 (~5%) of these narratives written in 2005 by young women and men aged 10–24 years from Senegal, Burkina Faso, South-East Nigeria, Kenya, Namibia and Swaziland. Abstinence was considerably more prominent as a theme in the samples from SE Nigeria, Kenya and Swaziland. It was articulated in relation to conservative Christian sexual morality and in opposition to condom use with particular intensity in SE Nigeria, with stigmatising implications for non-abstainers. However, cross-national commonalities were more striking than differences. Examples of non-stigmatising pro-abstinence messaging highlighted the appeal of discourses of romantic love and future plans across countries and demographic characteristics. The analysis yielded contextual understanding, youth-driven ideas, and recommendations to inform comprehensive HIV prevention efforts. PMID:21787256
Nguyen Thanh, Viet; Guignard, Romain; Lancrenon, Sylvie; Bertrand, Camille; Delva, Catherine; Berlin, Ivan; Pasquereau, Anne; Arwidson, Pierre
2018-01-23
The internet offers an interesting alternative to face-to-face and telephone-based support for smoking cessation. This study was designed to assess the effectiveness of a personalized and automated internet-based program. French current adult smokers willing to quit within 2 weeks were recruited for a randomized controlled trial. The intervention consisted of an automated program of 45 e-mails ("e-coaching") sent over a 3-month period. The control group received a PDF version of a booklet on smoking cessation. Self-reported 7-day point prevalence smoking abstinence was measured at 6 months (primary outcome), at 3 and 12 months of follow-up (secondary outcomes). 2,478 smokers were randomized (1,242 for e-coaching, 1,236 for the booklet). Cessation rate in the intention-to-treat population was not significantly different between the two groups at 6 and 12 months, but was higher in the e-coaching group at 3 months than in the control group (27.5% vs 23.5%, p=0.02, OR=1.24, CI=[1.03-1.49]). After adjustment for baseline conditions, the effect of the intervention in the per-protocol (PP) sample was significant at 3 months (aOR=1.72 [1.31-2.28], p<0.001, N=1042) and at 6 months (aOR=1.27 [1.00-1.60], p=0.05, N=1082). GLM repeated measure analyses showed significant group by time interaction in the ITT and a significant group effect in the PP population. Analyzed intention-to-treat, e-coaching was superior to a booklet at 3 months (end of intervention) but no more superior at 6 and 12 months follow up. Among those who actually followed the program, the effectiveness is also observed 3 months after the intervention is stopped. © The Author(s) 2018. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
Confidence intervals for a difference between lognormal means in cluster randomization trials.
Poirier, Julia; Zou, G Y; Koval, John
2017-04-01
Cluster randomization trials, in which intact social units are randomized to different interventions, have become popular in the last 25 years. Outcomes from these trials in many cases are positively skewed, following approximately lognormal distributions. When inference is focused on the difference between treatment arm arithmetic means, existent confidence interval procedures either make restricting assumptions or are complex to implement. We approach this problem by assuming log-transformed outcomes from each treatment arm follow a one-way random effects model. The treatment arm means are functions of multiple parameters for which separate confidence intervals are readily available, suggesting that the method of variance estimates recovery may be applied to obtain closed-form confidence intervals. A simulation study showed that this simple approach performs well in small sample sizes in terms of empirical coverage, relatively balanced tail errors, and interval widths as compared to existing methods. The methods are illustrated using data arising from a cluster randomization trial investigating a critical pathway for the treatment of community acquired pneumonia.
Muroff, Jordana; Amodeo, Maryann; Larson, Mary Jo; Carey, Margaret; Loftin, Ralph D
2011-01-01
This article describes a data management system (DMS) developed to support a large-scale randomized study of an innovative web-course that was designed to improve substance abuse counselors' knowledge and skills in applying a substance abuse treatment method (i.e., cognitive behavioral therapy; CBT). The randomized trial compared the performance of web-course-trained participants (intervention group) and printed-manual-trained participants (comparison group) to determine the effectiveness of the web-course in teaching CBT skills. A single DMS was needed to support all aspects of the study: web-course delivery and management, as well as randomized trial management. The authors briefly reviewed several other systems that were described as built either to handle randomized trials or to deliver and evaluate web-based training. However it was clear that these systems fell short of meeting our needs for simultaneous, coordinated management of the web-course and the randomized trial. New England Research Institute's (NERI) proprietary Advanced Data Entry and Protocol Tracking (ADEPT) system was coupled with the web-programmed course and customized for our purposes. This article highlights the requirements for a DMS that operates at the intersection of web-based course management systems and randomized clinical trial systems, and the extent to which the coupled, customized ADEPT satisfied those requirements. Recommendations are included for institutions and individuals considering conducting randomized trials and web-based training programs, and seeking a DMS that can meet similar requirements.
Understanding Sexual Abstinence in Urban Adolescent Girls
Morrison-Beedy, Dianne; Carey, Michael P.; Côté-Arsenault, Denise; Seibold-Simpson, Susan; Robinson, Kerry Anne
2008-01-01
Objectives To gain insight into the context of sexual abstinence and identify potential determinants of abstinence in this population. Design Four focus groups. Participants and Setting Twenty-four, predominantly African American (88%) girls aged 14 to 19 years were recruited from urban health centers and youth development programs in Rochester, New York, between September and December 2006. Data Analysis Content analysis was used to analyze the four verbatim transcripts. Using analytic induction, groups were compared and contrasted at the micro (within-group) and macro (between-group) levels to identify themes. Results Four themes were identified that provided insight into how and why these girls remain abstinent despite being in sexually active social climates. They focused on the following: self-respect (I'm worth it), impact of mothers (Mama says … think before you let it go), influence of boys and other peers (Boys will be boys), and potential negative consequences of sex (Hold on, there's a catch). Conclusions Developing interventions to maintain abstinence, delay onset of sexual activity, and promote protected first and subsequent sexual contact in abstinent girls are key to decreasing future sexual risk. These findings suggest opportunities to develop HIV prevention strategies tailored to the needs of abstinent girls. PMID:18336442
Lévesque, Annie; Campbell, Aimee N C; Pavlicova, Martina; Hu, Mei-Chen; Walker, Robrina; McClure, Erin A; Ghitza, Udi E; Bailey, Genie; Stitzer, Maxine; Nunes, Edward V
2017-02-01
Coping strategies are a predictor of abstinence among patients with substance use disorders. However, little is known regarding the role of coping strategies in the effectiveness of the Community Reinforcement Approach (CRA). Using data from a 12week randomized control trial assessing the effectiveness of the Therapeutic Education System (TES), an internet-delivered version of the CRA combined with contingency management, we tested the role of coping strategies as a mediator of treatment effectiveness. 507 participants entering 10 outpatient addiction treatment programs received either treatment-as-usual (TAU), a counselor-delivered treatment (Arm 1), or reduced TAU plus TES wherein 2h of TAU per week were replaced by TES (Arm 2). Abstinence from drugs and alcohol was evaluated using urine toxicology and self-report. Coping strategies were measured using the Coping Strategies Scale-Brief Version. Mediation analyses were done following Baron and Kenny's and path analysis approaches. The average baseline coping strategies scores were not significantly different between the two treatment arms. Overall, TES intervention was significantly associated with higher coping strategies scores when accounting for baseline scores (F 1,1342 =8.3, p=0.004). Additionally, higher coping strategies scores at week 12 were associated with an increased likelihood of abstinence during the last 4weeks of the treatment, while accounting for treatment assignment and baseline abstinence. The effect of TES intervention on abstinence was no longer significant after controlling for coping strategies scores at week 12. Our results support the importance of coping skills as a partial mediator of the effectiveness of an internet-version of the CRA combined with contingency management. Copyright © 2016. Published by Elsevier Ltd.
Reporting of participant flow diagrams in published reports of randomized trials.
Hopewell, Sally; Hirst, Allison; Collins, Gary S; Mallett, Sue; Yu, Ly-Mee; Altman, Douglas G
2011-12-05
Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams published in current reports of randomized trials. A cross sectional review of all primary reports of randomized trials which included a CONSORT flow diagram indexed in PubMed core clinical journals (2009). We assessed the proportion of parallel group trial publications reporting specific items recommended by CONSORT for inclusion in a flow diagram. Of 469 primary reports of randomized trials, 263 (56%) included a CONSORT flow diagram of which 89% (237/263) were published in a CONSORT endorsing journal. Reports published in CONSORT endorsing journals were more likely to include a flow diagram (62%; 237/380 versus 29%; 26/89). Ninety percent (236/263) of reports which included a flow diagram had a parallel group design, of which 49% (116/236) evaluated drug interventions, 58% (137/236) were multicentre, and 79% (187/236) compared two study groups, with a median sample size of 213 participants. Eighty-one percent (191/236) reported the overall number of participants assessed for eligibility, 71% (168/236) the number excluded prior to randomization and 98% (231/236) the overall number randomized. Reasons for exclusion prior to randomization were more poorly reported. Ninety-four percent (223/236) reported the number of participants allocated to each arm of the trial. However, only 40% (95/236) reported the number who actually received the allocated intervention, 67% (158/236) the number lost to follow up in each arm of the trial, 61% (145/236) whether participants discontinued the intervention during the trial and 54% (128/236) the number included in the main analysis. Over half of published reports of randomized trials included a diagram showing the flow of participants through the trial
Reporting of participant flow diagrams in published reports of randomized trials
2011-01-01
Background Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams published in current reports of randomized trials. Methods A cross sectional review of all primary reports of randomized trials which included a CONSORT flow diagram indexed in PubMed core clinical journals (2009). We assessed the proportion of parallel group trial publications reporting specific items recommended by CONSORT for inclusion in a flow diagram. Results Of 469 primary reports of randomized trials, 263 (56%) included a CONSORT flow diagram of which 89% (237/263) were published in a CONSORT endorsing journal. Reports published in CONSORT endorsing journals were more likely to include a flow diagram (62%; 237/380 versus 29%; 26/89). Ninety percent (236/263) of reports which included a flow diagram had a parallel group design, of which 49% (116/236) evaluated drug interventions, 58% (137/236) were multicentre, and 79% (187/236) compared two study groups, with a median sample size of 213 participants. Eighty-one percent (191/236) reported the overall number of participants assessed for eligibility, 71% (168/236) the number excluded prior to randomization and 98% (231/236) the overall number randomized. Reasons for exclusion prior to randomization were more poorly reported. Ninety-four percent (223/236) reported the number of participants allocated to each arm of the trial. However, only 40% (95/236) reported the number who actually received the allocated intervention, 67% (158/236) the number lost to follow up in each arm of the trial, 61% (145/236) whether participants discontinued the intervention during the trial and 54% (128/236) the number included in the main analysis. Conclusions Over half of published reports of randomized trials included a diagram showing the
A randomized trial comparing concise and standard consent forms in the START trial
Touloumi, Giota; Walker, A. Sarah; Smolskis, Mary; Sharma, Shweta; Babiker, Abdel G.; Pantazis, Nikos; Tavel, Jorge; Florence, Eric; Sanchez, Adriana; Hudson, Fleur; Papadopoulos, Antonios; Emanuel, Ezekiel; Clewett, Megan; Munroe, David; Denning, Eileen
2017-01-01
Background Improving the effectiveness and efficiency of research informed consent is a high priority. Some express concern about longer, more complex, written consent forms creating barriers to participant understanding. A recent meta-analysis concluded that randomized comparisons were needed. Methods We conducted a cluster-randomized non-inferiority comparison of a standard versus concise consent form within a multinational trial studying the timing of starting antiretroviral therapy in HIV+ adults (START). Interested sites were randomized to standard or concise consent forms for all individuals signing START consent. Participants completed a survey measuring comprehension of study information and satisfaction with the consent process. Site personnel reported usual site consent practices. The primary outcome was comprehension of the purpose of randomization (pre-specified 7.5% non-inferiority margin). Results 77 sites (2429 participants) were randomly allocated to use standard consent and 77 sites (2000 participants) concise consent, for an evaluable cohort of 4229. Site and participant characteristics were similar for the two groups. The concise consent was non-inferior to the standard consent on comprehension of randomization (80.2% versus 82%, site adjusted difference: 0.75% (95% CI -3.8%, +5.2%)); and the two groups did not differ significantly on total comprehension score, satisfaction, or voluntariness (p>0.1). Certain independent factors, such as education, influenced comprehension and satisfaction but not differences between consent groups. Conclusions An easier to read, more concise consent form neither hindered nor improved comprehension of study information nor satisfaction with the consent process among a large number of participants. This supports continued efforts to make consent forms more efficient. Trial registration Informed consent substudy was registered as part of START study in clinicaltrials.gov #NCT00867048, and EudraCT # 2008
Testing cardiovascular drug safety and efficacy in randomized trials.
FitzGerald, Garret A
2014-03-28
Randomized trials provide the gold standard evidence on which rests the decision to approve novel therapeutics for clinical use. They are large and expensive and provide average but unbiased estimates of efficacy and risk. Concern has been expressed about how unrepresentative populations and conditions that pertain in randomized trials might be of the real world, including concerns about the homogeneity of the biomedical and adherence characteristics of volunteers entered into such trials, the dose and constancy of drug administration and the mixture of additional medications that are restricted in such trials but might influence outcome in practice. A distinction has been drawn between trials that establish efficacy and those that demonstrate effectiveness, drugs that patients actually consume in the real world for clinical benefit. However, randomized controlled trials remain the gold standard for establishing efficacy and the testing of effectiveness with less rigorous approaches is a secondary, albeit important consideration. Despite this, there is an appreciation that average results may conceal considerable interindividual variation in drug response, leading to a failure to appreciate clinical value or risk in subsets of patients. Thus, attempts are now being made to individualize risk estimates by modulating those derived from large randomized trials with the individual baseline risk estimates based on demographic and biological criteria-the individual Numbers Needed to Treat to obtain a benefit, such as a life saved. Here, I will consider some reasons why large phase 3 trials-by far the most expensive element of drug development-may fail to address the unmet medical needs, which should justify such effort and investment.
Meyer, Christian; Ulbricht, Sabina; Haug, Severin; Broda, Anja; Bischof, Gallus; Rumpf, Hans-Jürgen; John, Ulrich
2016-09-01
This study examined the long-term efficacy of individualized counseling letters that targeted either smoking abstinence or reducing the number of cigarettes smoked per day to promote future cessation. A nationwide random-digit-dialing telephone sample was used to identify smokers from the general adult population (participation proportion: 54.5%). In total, 1462 participants (48% female) who did not intend to quit within the next six months and who smoked ten or more cigarettes a day were randomized to one of two intervention groups or an assessment-only control condition. The interventions consisted of three tailored letters that were sent after baseline and follow-up assessments after three and six months. Follow-up data on smoking status were provided by 82% and 77% of the participants 12 and 24 months after study inclusion, respectively. Generalized estimation equation (GEE) models adjusted for potential baseline confounders and multiple imputation of missing follow-up data were used to estimate intervention effects. At 24-month follow-up prevalence of 7-day point abstinence was 8.4%, 12.9% and 14.7% in the control, abstinence intervention and reduction intervention condition, which corresponds to a number needed to treat of 22 (95%-CI: 11-707) and 16 (95%-CI: 9-53). Adjusted GEE analyses revealed that the smoking reduction intervention (ORadj=2.3, p<0.01) but not the abstinence intervention (ORadj=1.4, p=0.20) increased the odds of 6-month prolonged abstinence compared with the control condition. No significant differences appear when directly comparing both intervention groups. Smoking reduction should be considered as an alternative intervention goal for smokers who are unable or unwilling to quit. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
Preference in Random Assignment: Implications for the Interpretation of Randomized Trials
Gold, Paul B.; Hargreaves, William A.; Aronson, Elliot; Bickman, Leonard; Barreira, Paul J.; Jones, Danson R.; Rodican, Charles F.; Fisher, William H.
2009-01-01
Random assignment to a preferred experimental condition can increase service engagement and enhance outcomes, while assignment to a less-preferred condition can discourage service receipt and limit outcome attainment. We examined randomized trials for one prominent psychiatric rehabilitation intervention, supported employment, to gauge how often assignment preference might have complicated the interpretation of findings. Condition descriptions, and greater early attrition from services-as-usual comparison conditions, suggest that many study enrollees favored assignment to new rapid-job-placement supported employment, but no study took this possibility into account. Reviews of trials in other service fields are needed to determine whether this design problem is widespread. PMID:19434489
Zhang, Jingwen; Jemmott, John B.; Jemmott, Loretta Sweet
2018-01-01
Objective This secondary data analysis sought to determine what mediated reductions in self-reported sexual initiation over the 24-month post-intervention period in early adolescents who received “Promoting Health among Teens,” a theory-based, abstinence-only intervention (Jemmott, Jemmott, & Fong, 2010). Methods African American grade 6 and 7 students at inner-city public middle schools were randomized to one of five interventions grounded in social cognitive theory and the theory of reasoned action: 8-hour abstinence-only targeting reduced sexual intercourse; 8-hour safer-sex-only targeting increased condom use; 8-hour and 12-hour comprehensive interventions targeting sexual intercourse and condom use; 8-hour control intervention targeting physical activity and diet. Primary outcome was self-report of vaginal intercourse by 24 months post-intervention. Potential mediators, assessed immediately post-intervention, were theory-of-reasoned-action variables, including behavioral beliefs about positive consequences of abstinence and negative consequences of sex, intention to have sex, normative beliefs about sex, and HIV/STI knowledge. We tested single and serial mediation models using the product-of-coefficients approach. Results Of 509 students reporting never having vaginal intercourse at baseline (324 girls and 185 boys; mean age = 11.8 years; SD = 0.8), 500 or 98.2% were included in serial mediation analyses. Consistent with the theory of reasoned action, the abstinence-only intervention increased positive behavioral beliefs about abstinence, which reduced intention to have sex, which in turn reduced sexual initiation. Negative behavioral beliefs about sex, normative beliefs about sex, and HIV/STI knowledge were not mediators. Conclusions Abstinence-only interventions should stress the gains to be realized from abstinence rather than the deleterious consequences of sexual involvement. PMID:26214076
Financial management of a large multisite randomized clinical trial.
Sheffet, Alice J; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E; Longbottom, Mary E; Howard, Virginia J; Marler, John R; Brott, Thomas G
2014-08-01
The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years' funding ($21 112 866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2500 randomized participants at 40 sites. Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Projections of the original grant's fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant's fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2500 targeted sample size, 138 (5·5%) were randomized during the first five years and 1387 (55·5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13 845) of the projected per-patient costs ($152 992) of the fixed model. Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. © 2014 The Authors. International Journal of Stroke © 2014 World Stroke Organization.
University students' definitions of sexual abstinence and having sex.
Byers, E Sandra; Henderson, Joel; Hobson, Kristina M
2009-10-01
We asked 298 heterosexual Canadian university students about their definitions of the terms abstinence and having sex. For both terms, students were provided with a list of 17 sexual behaviors and indicated whether they would include each in their definition. The majority of both male and female students included activities that did not involve genital stimulation in their definition of sexual abstinence and did not include these activities in their definition of having sex. Conversely, most students did not include bidirectional sexual stimulation (penile-vaginal intercourse or penile-anal intercourse) in their definitions of sexual abstinence but did include them in their definitions of having sex. Students were quite mixed in whether activities involving unidirectional genital stimulation (e.g., oral sex, genital fondling) constituted abstinence, having sex, or neither abstinence nor having sex. However, they were more likely to see these behaviors as abstinent than as having sex. Students were more likely to rate a behavior as abstinence if orgasm did not occur. A canonical correlation analysis was used to examine the patterns of association between a number of predictors and inclusions of behaviors involving no genital stimulation, unidirectional stimulation, and bidirectional genital stimulation in abstinence definitions. The results indicated that male participants who were more involved with their religion and sexually conservative, less sexually experienced, and who had not received sexual health education at home were more likely to define bidirectional genital stimulation and less likely to define no genital stimulation and unidirectional sexual stimulation as sexual abstinence. The research and health promotion implications of these results are discussed.
Wang, Dongming; Li, Wenzhen; Xiao, Yang; He, Wulong; Wei, Weiquan; Yang, Longyu; Yu, Jincong; Song, Fujian; Wang, Zengzhen
2016-07-01
New-type drugs are popular with adolescents and could lead to psychiatry disorders, but no medications have been proven to be effective for these disorders of new-type drug dependence. We aimed to evaluate the efficacy of tryptophan on sleeping disorders and mental symptoms in detoxified individuals with new-type drug dependence. This randomized, placebo-controlled trial included 80 detoxified individuals with new-type drug dependence, recruited successively from a Compulsory Residential Drug Abstinence Institution in Wuhan, China, from April 2012 to November 2012. Eligible participants were randomly allocated to be treated with tryptophan (1000 mg/d, n = 40) or placebo (n = 40) for 2 weeks. The sleeping disorders and mental symptoms were assessed using Athens Insomnia Scale and Symptom Check-List-90 at baseline and 2 weeks. Results were analyzed according to the "intention-to-treat" approach. Forty-five participants completed the 2-week study, 24 in the tryptophan group and 21 in the placebo group. There were no statistically significant differences in baseline characteristics between groups and the treatment adherence was similar between groups. The reduction in the Athens Insomnia Scale score in the tryptophan group was significantly greater than that in the placebo group (P = 0.017). However, no significant differences were found in Symptom Check-List-90 scores (either by individual dimension or the overall score) between groups (all P > 0.05). The frequency of adverse events was similar and no serious adverse events were reported during the study. Tryptophan was unlikely to be effective for mental symptoms, but could alleviate sleep disorders in short term among detoxified individuals with new-type drug dependence. Future large-scale trials are required to confirm findings from this study.
Reducing sexual risk with practice of periodic secondary abstinence.
Haglund, Kristin
2008-01-01
Test a novel intervention to help sexually experienced girls increase abstinence behaviors and attitudes. A quasi-experimental repeated measures design using qualitative and quantitative data. Two alternative public schools. Thirty-three females whose mean age was 16 and who were 79% African American participated. Most (79%) had experienced a pregnancy. A 6 session, weekly, interactive intervention was delivered. Data were collected at baseline, last session, and at 5 and 7 month follow-ups. Measured outcomes related to abstinence included participants' reasons, behaviors, stages of change, and attitudes. The most common reason for abstinence was not wanting to have sex. At each postintervention data collection point, most participants (greater than or equal to 74%) reported that they had purposefully avoided sex. Duration of consecutive days of abstinence increased although only significantly at 5 month follow-up. Abstinence behaviors increased with the largest change from first to last session. Stage of change advanced from preparation to action by 7 month follow-up. Attitudes toward abstinence became more favorable. Effective sexual risk reduction interventions are critically needed to promote safety. Nurses may assist young women to decrease their sexual risks by teaching them to practice periodic abstinence.
A Data Management System Integrating Web-Based Training and Randomized Trials
ERIC Educational Resources Information Center
Muroff, Jordana; Amodeo, Maryann; Larson, Mary Jo; Carey, Margaret; Loftin, Ralph D.
2011-01-01
This article describes a data management system (DMS) developed to support a large-scale randomized study of an innovative web-course that was designed to improve substance abuse counselors' knowledge and skills in applying a substance abuse treatment method (i.e., cognitive behavioral therapy; CBT). The randomized trial compared the performance…
Testing Cardiovascular Drug Safety and Efficacy in Randomized Trials
FitzGerald, Garret A.
2014-01-01
Randomized trials provide the gold standard evidence on which rests the decision to approve novel therapeutics for clinical use. They are large and expensive and provide average, but unbiased estimates of efficacy and risk. Concern has been expressed about how “unrepresentative” populations and conditions that pertain in randomized trials might be of the “real world”, including concerns about the homogeneity of the biomedical and adherence characteristics of volunteers entered into such trials, the dose and constancy of drug administration and the mixture of additional medications that are restricted in such trials but might influence outcome in practice. A distinction has been drawn between trials which establish “efficacy” and those that demonstrate “effectiveness” - drugs that patients actually consume in the “real world” for clinical benefit1. However, randomized controlled trials remain the gold standard for establishing efficacy and the testing of “effectiveness” with less rigorous approaches is a secondary, albeit important consideration. Despite this, there is an appreciation that “average” results may conceal considerable inter-individual variation in drug response, leading to a failure to appreciate clinical value or risk in subsets of patients2,3Thus, attempts are now being made to individualize risk estimates by modulating those derived from large randomized trials with the individual baseline risk estimates based on demographic and biological criteria - the individual Numbers Needed to Treat to obtain a benefit, such as a life saved4. Here, I will consider some reasons why large phase 3 trials - by far the most expensive element of drug development - may fail to address the “unmet medical needs” which should justify such effort and investment. PMID:24677235
Aveyard, Paul; Griffin, Carl; Lawrence, Terry; Cheng, K K
2003-03-01
To examine the population impact and effectiveness of the Pro-Change smoking cessation course based on the Transtheoretical Model (TTM) compared to standard self-help smoking cessation literature. Randomized controlled trial. Sixty-five West Midlands general practices. Randomly sampled patients recorded as smokers by their general practitioners received an invitation letter and 2471 current smokers agreed. Responders were randomized to one of four interventions. The control group received standard self-help literature. In the Manual intervention group, participants received the Pro-Change system, a self-help workbook and three questionnaires at 3-monthly intervals, which generated individually tailored feedback. In the Phone intervention group, participants received the Manual intervention plus three telephone calls. In the Nurse intervention group, participants received the Manual intervention plus three visits to the practice nurse. Biochemically confirmed point prevalence of being quit and 6-month sustained abstinence, 12 months after study commencement. A total of 9.1% of registered current smokers participated, of whom 83.0% were not ready to quit. Less than half of participants returned questionnaires to generate second and third individualized feedback. Telephone calls reached 75% of those scheduled, but few participants visited the nurse. There were small differences between the three Pro-Change arms. The odds ratio (95% confidence intervals) for all Pro-Change arms combined versus the control arm were 1.50 (0.85-2.67) and 1.53 (0.76-3.10), for point prevalence and 6-month abstinence, respectively. This constitutes 2.1% of the TTM group versus 1.4% of the control group achieving confirmed 6-month sustained abstinence. There was no statistically significant benefit of the intervention apparent in this trial and the high relapse of quitters means that any population impact is small.
Arabi, Yaseen; Al-Hameed, Fahad; Burns, Karen E A; Mehta, Sangeeta; Alsolamy, Sami; Almaani, Mohammed; Mandourah, Yasser; Almekhlafi, Ghaleb A; Al Bshabshe, Ali; Finfer, Simon; Alshahrani, Mohammed; Khalid, Imran; Mehta, Yatin; Gaur, Atul; Hawa, Hassan; Buscher, Hergen; Arshad, Zia; Lababidi, Hani; Al Aithan, Abdulsalam; Jose, Jesna; Abdukahil, Sheryl Ann I; Afesh, Lara Y; Dbsawy, Maamoun; Al-Dawood, Abdulaziz
2018-03-15
The Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial evaluates the effect of adjunctive intermittent pneumatic compression (IPC) with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on venous thromboembolism (VTE) in critically ill adults. In this multicenter randomized trial, critically ill patients receiving pharmacologic thromboprophylaxis will be randomized to an IPC or a no IPC (control) group. The primary outcome is "incident" proximal lower-extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation, whereas the patients and treating team will be unblinded. The trial has 80% power to detect a 3% absolute risk reduction in the rate of proximal DVT from 7% to 4%. Consistent with international guidelines, we have developed a detailed plan to guide the analysis of the PREVENT trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes, and defines covariates for adjusted analyses a priori. Application of this statistical analysis plan to the PREVENT trial will facilitate unbiased analyses of clinical data. ClinicalTrials.gov , ID: NCT02040103 . Registered on 3 November 2013; Current controlled trials, ID: ISRCTN44653506 . Registered on 30 October 2013.
Altstein, L.; Li, G.
2012-01-01
Summary This paper studies a semiparametric accelerated failure time mixture model for estimation of a biological treatment effect on a latent subgroup of interest with a time-to-event outcome in randomized clinical trials. Latency is induced because membership is observable in one arm of the trial and unidentified in the other. This method is useful in randomized clinical trials with all-or-none noncompliance when patients in the control arm have no access to active treatment and in, for example, oncology trials when a biopsy used to identify the latent subgroup is performed only on subjects randomized to active treatment. We derive a computational method to estimate model parameters by iterating between an expectation step and a weighted Buckley-James optimization step. The bootstrap method is used for variance estimation, and the performance of our method is corroborated in simulation. We illustrate our method through an analysis of a multicenter selective lymphadenectomy trial for melanoma. PMID:23383608
Radiation Therapy Intensification for Solid Tumors: A Systematic Review of Randomized Trials
DOE Office of Scientific and Technical Information (OSTI.GOV)
Yamoah, Kosj; Showalter, Timothy N.; Ohri, Nitin, E-mail: ohri.nitin@gmail.com
Purpose: To systematically review the outcomes of randomized trials testing radiation therapy (RT) intensification, including both dose escalation and/or the use of altered fractionation, as a strategy to improve disease control for a number of malignancies. Methods and Materials: We performed a literature search to identify randomized trials testing RT intensification for cancers of the central nervous system, head and neck, breast, lung, esophagus, rectum, and prostate. Findings were described qualitatively. Where adequate data were available, pooled estimates for the effect of RT intensification on local control (LC) or overall survival (OS) were obtained using the inverse variance method. Results: Inmore » primary central nervous system tumors, esophageal cancer, and rectal cancer, randomized trials have not demonstrated that RT intensification improves clinical outcomes. In breast cancer and prostate cancer, dose escalation has been shown to improve LC or biochemical disease control but not OS. Radiation therapy intensification may improve LC and OS in head and neck and lung cancers, but these benefits have generally been limited to studies that did not incorporate concurrent chemotherapy. Conclusions: In randomized trials, the benefits of RT intensification have largely been restricted to trials in which concurrent chemotherapy was not used. Novel strategies to optimize the incorporation of RT in the multimodality treatment of solid tumors should be explored.« less
Duncan, Pamela W; Sullivan, Katherine J; Behrman, Andrea L; Azen, Stanley P; Wu, Samuel S; Nadeau, Stephen E; Dobkin, Bruce H; Rose, Dorian K; Tilson, Julie K
2007-01-01
Background Locomotor training using body weight support and a treadmill as a therapeutic modality for rehabilitation of walking post-stroke is being rapidly adopted into clinical practice. There is an urgent need for a well-designed trial to determine the effectiveness of this intervention. The objective of the Locomotor Experience Applied Post-Stroke (LEAPS) trial is to determine if there is a difference in the proportion of participants who recover walking ability at one year post-stroke when randomized to a specialized locomotor training program (LTP), conducted at 2- or 6-months post-stroke, or those randomized to a home based non-specific, low intensity exercise intervention (HEP) provided 2 months post-stroke. We will determine if the timing of LTP delivery affects gait speed at 1 year and whether initial impairment severity interacts with the timing of LTP. The effect of number of treatment sessions will be determined by changes in gait speed taken pre-treatment and post-12, -24, and -36 sessions. Methods/Design We will recruit 400 adults with moderate or severe walking limitations within 30 days of stroke onset. At two months post stroke, participants are stratified by locomotor impairment severity as determined by overground walking speed and randomly assigned to one of three groups: (a) LTP-Early; (b) LTP-Late or (c) Home Exercise Program -Early. The LTP program includes body weight support on a treadmill and overground training. The LTP and HEP interventions are delivered for 36 sessions over 12 weeks. Primary outcome measure include successful walking recovery defined as the achievement of a 0.4 m/s gait speed or greater by persons with initial severe gait impairment or the achievement of a 0.8 m/s gait speed or greater by persons with initial moderate gait impairment. LEAPS is powered to detect a 20% difference in the proportion of participants achieving successful locomotor recovery between the LTP groups and the HEP group, and a 0.1 m/s mean
Ewing, Alexander C.; Kottke, Melissa J.; Kraft, Joan Marie; Sales, Jessica M.; Brown, Jennifer L.; Goedken, Peggy; Wiener, Jeffrey; Kourtis, Athena P.
2018-01-01
Background African American adolescent females are at elevated risk for unintended pregnancy and sexually transmitted infections (STIs). Dual protection (DP) is defined as concurrent prevention of pregnancy and STIs. This can be achieved by abstinence, consistent condom use, or the dual methods of condoms plus an effective non-barrier contraceptive. Previous clinic-based interventions showed short-term effects on increasing dual method use, but evidence of sustained effects on dual method use and decreased incident pregnancies and STIs are lacking. Methods/Design This manuscript describes the 2GETHER Project. 2GETHER is a randomized controlled trial of a multi-component intervention to increase dual protection use among sexually active African American females aged 14–19 years not desiring pregnancy at a Title X clinic in Atlanta, GA. The intervention is clinic-based and includes a culturally tailored interactive multimedia component and counseling sessions, both to assist in selection of a DP method and to reinforce use of the DP method. The participants are randomized to the study intervention or the standard of care, and followed for 12 months to evaluate how the intervention influences DP method selection and adherence, pregnancy and STI incidence, and participants’ DP knowledge, intentions, and self-efficacy. Discussion The 2GETHER Project is a novel trial to reduce unintended pregnancies and STIs among African American adolescents. The intervention is unique in the comprehensive and complementary nature of its components and its individual tailoring of provider-patient interaction. If the trial interventions are shown to be effective, then it will be reasonable to assess their scalability and applicability in other populations. PMID:28007634
Ewing, Alexander C; Kottke, Melissa J; Kraft, Joan Marie; Sales, Jessica M; Brown, Jennifer L; Goedken, Peggy; Wiener, Jeffrey; Kourtis, Athena P
2017-03-01
African American adolescent females are at elevated risk for unintended pregnancy and sexually transmitted infections (STIs). Dual protection (DP) is defined as concurrent prevention of pregnancy and STIs. This can be achieved by abstinence, consistent condom use, or the dual methods of condoms plus an effective non-barrier contraceptive. Previous clinic-based interventions showed short-term effects on increasing dual method use, but evidence of sustained effects on dual method use and decreased incident pregnancies and STIs are lacking. This manuscript describes the 2GETHER Project. 2GETHER is a randomized controlled trial of a multi-component intervention to increase dual protection use among sexually active African American females aged 14-19years not desiring pregnancy at a Title X clinic in Atlanta, GA. The intervention is clinic-based and includes a culturally tailored interactive multimedia component and counseling sessions, both to assist in selection of a DP method and to reinforce use of the DP method. The participants are randomized to the study intervention or the standard of care, and followed for 12months to evaluate how the intervention influences DP method selection and adherence, pregnancy and STI incidence, and participants' DP knowledge, intentions, and self-efficacy. The 2GETHER Project is a novel trial to reduce unintended pregnancies and STIs among African American adolescents. The intervention is unique in the comprehensive and complementary nature of its components and its individual tailoring of provider-patient interaction. If the trial interventions are shown to be effective, then it will be reasonable to assess their scalability and applicability in other populations. Published by Elsevier Inc.
Gruber, Joshua S; Arnold, Benjamin F; Reygadas, Fermin; Hubbard, Alan E; Colford, John M
2014-05-01
Complier average causal effects (CACE) estimate the impact of an intervention among treatment compliers in randomized trials. Methods used to estimate CACE have been outlined for parallel-arm trials (e.g., using an instrumental variables (IV) estimator) but not for other randomized study designs. Here, we propose a method for estimating CACE in randomized stepped wedge trials, where experimental units cross over from control conditions to intervention conditions in a randomized sequence. We illustrate the approach with a cluster-randomized drinking water trial conducted in rural Mexico from 2009 to 2011. Additionally, we evaluated the plausibility of assumptions required to estimate CACE using the IV approach, which are testable in stepped wedge trials but not in parallel-arm trials. We observed small increases in the magnitude of CACE risk differences compared with intention-to-treat estimates for drinking water contamination (risk difference (RD) = -22% (95% confidence interval (CI): -33, -11) vs. RD = -19% (95% CI: -26, -12)) and diarrhea (RD = -0.8% (95% CI: -2.1, 0.4) vs. RD = -0.1% (95% CI: -1.1, 0.9)). Assumptions required for IV analysis were probably violated. Stepped wedge trials allow investigators to estimate CACE with an approach that avoids the stronger assumptions required for CACE estimation in parallel-arm trials. Inclusion of CACE estimates in stepped wedge trials with imperfect compliance could enhance reporting and interpretation of the results of such trials.
Bayesian network meta-analysis for cluster randomized trials with binary outcomes.
Uhlmann, Lorenz; Jensen, Katrin; Kieser, Meinhard
2017-06-01
Network meta-analysis is becoming a common approach to combine direct and indirect comparisons of several treatment arms. In recent research, there have been various developments and extensions of the standard methodology. Simultaneously, cluster randomized trials are experiencing an increased popularity, especially in the field of health services research, where, for example, medical practices are the units of randomization but the outcome is measured at the patient level. Combination of the results of cluster randomized trials is challenging. In this tutorial, we examine and compare different approaches for the incorporation of cluster randomized trials in a (network) meta-analysis. Furthermore, we provide practical insight on the implementation of the models. In simulation studies, it is shown that some of the examined approaches lead to unsatisfying results. However, there are alternatives which are suitable to combine cluster randomized trials in a network meta-analysis as they are unbiased and reach accurate coverage rates. In conclusion, the methodology can be extended in such a way that an adequate inclusion of the results obtained in cluster randomized trials becomes feasible. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.
Randomized controlled trials in mild cognitive impairment
Thomas, Ronald G.; Aisen, Paul S.; Mohs, Richard C.; Carrillo, Maria C.; Albert, Marilyn S.
2017-01-01
Objective: To examine the variability in performance among placebo groups in randomized controlled trials for mild cognitive impairment (MCI). Methods: Placebo group data were obtained from 2 National Institute on Aging (NIA) MCI randomized controlled trials, the Alzheimer's Disease Cooperative Study (ADCS) MCI trial and the Alzheimer's Disease Neuroimaging Initiative (ADNI), which is a simulated clinical trial, in addition to industry-sponsored clinical trials involving rivastigmine, galantamine, rofecoxib, and donepezil. The data were collated for common measurement instruments. The performance of the placebo participants from these studies was tracked on the Alzheimer's Disease Assessment Scale–cognitive subscale, Mini-Mental State Examination, and Clinical Dementia Rating–sum of boxes, and for progression on these measures to prespecified clinical study endpoints. APOE status, where available, was also analyzed for its effects. Results: The progression to clinical endpoints varied a great deal among the trials. The expected performances were seen for the participants in the 2 NIA trials, ADCS and ADNI, with generally worsening of performance over time; however, the industry-sponsored trials largely showed stable or improved performance in their placebo participants. APOE4 carrier status influenced results in an expected fashion on the study outcomes, including rates of progression and cognitive subscales. Conclusions: In spite of apparently similar criteria for MCI being adopted by the 7 studies, the implementation of the criteria varied a great deal. Several explanations including instruments used to characterize participants and variability among study populations contributed to the findings. PMID:28381516
Literate Language Intervention with High-Need Prekindergarten Children: A Randomized Trial
ERIC Educational Resources Information Center
Phillips, Beth M.; Tabulda, Galiya; Ingrole, Smriti A.; Webb Burris, Pam; Sedgwick, T. Kayla; Chen, Shiyi
2016-01-01
Purpose: The present article reports on the implementation and results of a randomized intervention trial targeting the literate language skills of prekindergarten children without identified language disorders but with low oral language skills. Method: Children (N = 82; 45 boys and 37 girls) were screened-in and randomized to a business-as-usual…
Humphreys, Keith; Blodgett, Janet C.; Wagner, Todd H.
2014-01-01
Background Observational studies of Alcoholics Anonymous’ (AA) effectiveness are vulnerable to self-selection bias because individuals choose whether or not to attend AA. The present study therefore employed an innovative statistical technique to derive a selection bias-free estimate of AA’s impact. Methods Six datasets from 5 National Institutes of Health-funded randomized trials (one with two independent parallel arms) of AA facilitation interventions were analyzed using instrumental variables models. Alcohol dependent individuals in one of the datasets (n = 774) were analyzed separately from the rest of sample (n = 1582 individuals pooled from 5 datasets) because of heterogeneity in sample parameters. Randomization itself was used as the instrumental variable. Results Randomization was a good instrument in both samples, effectively predicting increased AA attendance that could not be attributed to self-selection. In five of the six data sets, which were pooled for analysis, increased AA attendance that was attributable to randomization (i.e., free of self-selection bias) was effective at increasing days of abstinence at 3-month (B = .38, p = .001) and 15-month (B = 0.42, p = .04) follow-up. However, in the remaining dataset, in which pre-existing AA attendance was much higher, further increases in AA involvement caused by the randomly assigned facilitation intervention did not affect drinking outcome. Conclusions For most individuals seeking help for alcohol problems, increasing AA attendance leads to short and long term decreases in alcohol consumption that cannot be attributed to self-selection. However, for populations with high pre-existing AA involvement, further increases in AA attendance may have little impact. PMID:25421504
Methods for sample size determination in cluster randomized trials
Rutterford, Clare; Copas, Andrew; Eldridge, Sandra
2015-01-01
Background: The use of cluster randomized trials (CRTs) is increasing, along with the variety in their design and analysis. The simplest approach for their sample size calculation is to calculate the sample size assuming individual randomization and inflate this by a design effect to account for randomization by cluster. The assumptions of a simple design effect may not always be met; alternative or more complicated approaches are required. Methods: We summarise a wide range of sample size methods available for cluster randomized trials. For those familiar with sample size calculations for individually randomized trials but with less experience in the clustered case, this manuscript provides formulae for a wide range of scenarios with associated explanation and recommendations. For those with more experience, comprehensive summaries are provided that allow quick identification of methods for a given design, outcome and analysis method. Results: We present first those methods applicable to the simplest two-arm, parallel group, completely randomized design followed by methods that incorporate deviations from this design such as: variability in cluster sizes; attrition; non-compliance; or the inclusion of baseline covariates or repeated measures. The paper concludes with methods for alternative designs. Conclusions: There is a large amount of methodology available for sample size calculations in CRTs. This paper gives the most comprehensive description of published methodology for sample size calculation and provides an important resource for those designing these trials. PMID:26174515
Herbeck, Diane M; Brecht, Mary-Lynn; Christou, Dayna; Lovinger, Katherine
2014-01-01
To better understand methamphetamine (MA) use patterns and the process of recovery, qualitative interviews were conducted with adult MA users (n = 20), comparing a sample that received substance abuse treatment with those who had not received treatment. Respondents provided detailed information on why and how they changed from use to abstinence and factors they considered to be barriers to abstinence. Audio recordings and transcripts were reviewed for common themes. Participants reported a range of mild/moderate to intensely destructive problems, including loss of important relationships and profound changes to who they felt they were at their core; e.g., "I didn't realize how dark and mean I was … I was like a different person." Initial abstinence was often facilitated by multiple external forces (e.g., drug testing, child custody issues, prison, relocation), but sustained abstinence was attributed to shifts in thinking and salient realizations about using. The treatment group reported using more and different resources to maintain their abstinence than the no-treatment group. Findings indicate individualized interventions and multiple, simultaneous approaches and resources were essential in reaching stable abstinence. Understanding long-term users' experiences with MA use, addiction, and abstinence can inform strategies for engaging and sustaining MA users in treatment and recovery.
Herbeck, Diane M.; Brecht, Mary-Lynn; Christou, Dayna; Lovinger, Katherine
2014-01-01
To better understand methamphetamine (MA) use patterns and the process of recovery, qualitative interviews were conducted with adult MA users (n=20), comparing a sample that received substance abuse treatment with those who had not received treatment. Respondents provided detailed information on why and how they changed from use to abstinence, and factors they considered to be barriers to abstinence. Audio recordings and transcripts were reviewed for common themes. Participants reported a range of mild/moderate to intensely destructive problems, including loss of important relationships and profound changes to who they felt they were at their core, e.g., “I didn’t realize how dark and mean I was... I was like a different person.” Initial abstinence was often facilitated by multiple external forces (e.g., drug testing, child custody issues, prison, relocation), but sustained abstinence was attributed to shifts in thinking and salient realizations about using. The treatment group reported using more and different resources to maintain their abstinence than the no treatment group. Findings indicate individualized interventions and multiple, simultaneous approaches and resources were essential in reaching stable abstinence. Understanding long-term users’ experiences with MA use, addiction and abstinence can inform strategies for engaging and sustaining MA users in treatment and recovery. PMID:25052880
Abstinence-Only Sex Education: College Students' Evaluations and Responses
ERIC Educational Resources Information Center
Gardner, Emily A.
2015-01-01
This qualitative study explores the abstinence-only sex education experiences of a small group of young adults in the southeastern USA. Most participants felt that their abstinence-only sex education had mixed value and low overall impact in their lives. Perceptions about abstinence, virginity, and marriage varied significantly from those stressed…
Demaerschalk, Bart M; Brown, Robert D; Roubin, Gary S; Howard, Virginia J; Cesko, Eldina; Barrett, Kevin M; Longbottom, Mary E; Voeks, Jenifer H; Chaturvedi, Seemant; Brott, Thomas G; Lal, Brajesh K; Meschia, James F; Howard, George
2017-09-01
Multicenter clinical trials attempt to select sites that can move rapidly to randomization and enroll sufficient numbers of patients. However, there are few assessments of the success of site selection. In the CREST-2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trials), we assess factors associated with the time between site selection and authorization to randomize, the time between authorization to randomize and the first randomization, and the average number of randomizations per site per month. Potential factors included characteristics of the site, specialty of the principal investigator, and site type. For 147 sites, the median time between site selection to authorization to randomize was 9.9 months (interquartile range, 7.7, 12.4), and factors associated with early site activation were not identified. The median time between authorization to randomize and a randomization was 4.6 months (interquartile range, 2.6, 10.5). Sites with authorization to randomize in only the carotid endarterectomy study were slower to randomize, and other factors examined were not significantly associated with time-to-randomization. The recruitment rate was 0.26 (95% confidence interval, 0.23-0.28) patients per site per month. By univariate analysis, factors associated with faster recruitment were authorization to randomize in both trials, principal investigator specialties of interventional radiology and cardiology, pre-trial reported performance >50 carotid angioplasty and stenting procedures per year, status in the top half of recruitment in the CREST trial, and classification as a private health facility. Participation in StrokeNet was associated with slower recruitment as compared with the non-StrokeNet sites. Overall, selection of sites with high enrollment rates will likely require customization to align the sites selected to the factor under study in the trial. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02089217. © 2017
Diederichsen, Axel Cosmus Pyndt; Rasmussen, Lars Melholt; Søgaard, Rikke; Lambrechtsen, Jess; Steffensen, Flemming Hald; Frost, Lars; Egstrup, Kenneth; Urbonaviciene, Grazina; Busk, Martin; Olsen, Michael Hecht; Mickley, Hans; Hallas, Jesper; Lindholt, Jes Sanddal
2015-12-05
The significant increase in the average life expectancy has increased the societal challenge of managing serious age-related diseases, especially cancer and cardiovascular diseases. A routine check by a general practitioner is not sufficient to detect incipient cardiovascular disease. Population-based randomized clinically controlled screening trial. 45,000 Danish men aged 65-74 years living on the Island of Funen, or in the surrounding communities of Vejle and Silkeborg. No exclusion criteria are used. One-third will be invited to cardiovascular seven-faceted screening examinations at one of four locations. The screening will include: (1) low-dose non-contrast CT scan to detect coronary artery calcification and aortic/iliac aneurysms, (2) brachial and ankle blood pressure index to detect peripheral arterial disease and hypertension, (3) a telemetric assessment of the heart rhythm, and (4) a measurement of the cholesterol and plasma glucose levels. Up-to-date cardiovascular preventive treatment is recommended in case of positive findings. To investigate whether advanced cardiovascular screening will prevent death and cardiovascular events, and whether the possible health benefits are cost effective. Registry-based follow-up on all cause death (primary outcome), and costs after 3, 5 and 10 years (secondary outcome). Each of the 45,000 individuals is, by EPIDATA, given a random number from 1-100. Those numbered 67+ will be offered screening; the others will act as a control group. Only those randomized to the screening will be invited to the examination;the remaining participants will not. Numbers randomized: A total of 45,000 men will be randomized 1:2. Recruitment: Enrollment started October 2014. A 5% reduction in overall mortality (HR=0.95), with the risk for a type 1 error=5% and the risk for a type II error=80%, is expected. We expect a 2-year enrollment, a 10-year follow-up, and a median survival of 15 years among the controls. The attendance to screening is
Testing a workplace physical activity intervention: a cluster randomized controlled trial
2011-01-01
Background Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. Methods A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form) and health outcomes were assessed. Results and discussion Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ) at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B = -1.79 mm/Hg) and resting heart rate (B = -2.08 beats) and significantly increased body mass index (B = .18 units) compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. Conclusions The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. Trial registration Current controlled trials ISRCTN08807396 PMID:21481265
Characterizing Smoking and Drinking Abstinence from Social Media.
Tamersoy, Acar; De Choudhury, Munmun; Chau, Duen Horng
2015-09-01
Social media has been established to bear signals relating to health and well-being states. In this paper, we investigate the potential of social media in characterizing and understanding abstinence from tobacco or alcohol use. While the link between behavior and addiction has been explored in psychology literature, the lack of longitudinal self-reported data on long-term abstinence has challenged addiction research. We leverage the activity spanning almost eight years on two prominent communities on Reddit: StopSmoking and StopDrinking. We use the self-reported "badge" information of nearly a thousand users as gold standard information on their abstinence status to characterize long-term abstinence. We build supervised learning based statistical models that use the linguistic features of the content shared by the users as well as the network structure of their social interactions. Our findings indicate that long-term abstinence from smoking or drinking (~one year) can be distinguished from short-term abstinence (~40 days) with 85% accuracy. We further show that language and interaction on social media offer powerful cues towards characterizing these addiction-related health outcomes. We discuss the implications of our findings in social media and health research, and in the role of social media as a platform for positive behavior change and therapy.
Part versus Whole: A Randomized Trial of Central Venous Catheterization Education
ERIC Educational Resources Information Center
Chan, Angela; Singh, Sunita; Dubrowski, Adam; Pratt, Daniel D.; Zalunardo, Nadia; Nair, Parvarthy; McLaughlin, Kevin; Ma, Irene W. Y.
2015-01-01
Central venous catheterization (CVC) is a complex but commonly performed procedure. How best to teach this complex skill has not been clearly delineated. We conducted a randomized trial of the effects of two types of teaching of CVC on skill acquisition and retention. We randomly assigned novice internal medicine residents to learning CVC in-part…
ERIC Educational Resources Information Center
Killen, Joel D.; Robinson, Thomas N.; Ammerman, Seth; Hayward, Chris; Rogers, Jayna; Stone, Christi; Samuels, Deanne; Levin, Sara K.; Green, Sarah
2004-01-01
Adolescent smokers (N = 211) were randomized to 1 of 2 groups: (a) nicotine patch plus bupropion SR (sustained release; 150 mg per day) or (b) nicotine patch plus placebo. Group skills training sessions were conducted each week by research staff. Abstinence rates at Weeks 10 and 26 were as follows: (a) patch plus bupropion, 23% and 8%, (b) patch…
Niemiec, Christopher P.; Ryan, Richard M.; Deci, Edward L.; Williams, Geoffrey C.
2009-01-01
Objective To assess aspirations for physical health over 18 months. To examine whether maintained importance of aspirations for physical health mediated and/or moderated the effect of an intensive intervention on long-term tobacco abstinence. Methods Participants were randomly assigned to an intervention based on self-determination theory or to community care, and provided data at baseline and at 18 and 30 months post-randomization. Results Aspirations for physical health were better maintained over 18 months among participants in the intervention (mean change = .05), relative to community care (mean change = -.13), t = 2.66, p < .01. Maintained importance of aspirations for physical health partially mediated the treatment condition effects on seven-day point prevalence tobacco abstinence (z′ = 1.68, p < .01) and the longest number of days not smoking (z′ = 2.16, p < .01), and interacted with treatment condition to facilitate the longest number of days not smoking (β = .08, p < .05). Conclusion Maintained importance of aspirations for physical health facilitated tobacco abstinence. Practice implications Smokers may benefit from discussing aspirations for physical health within autonomy-supportive interventions. Patients may benefit from discussing aspirations during counseling about therapeutic lifestyle change and medication use. PMID:18838243
Niemiec, Christopher P; Ryan, Richard M; Deci, Edward L; Williams, Geoffrey C
2009-02-01
To assess aspirations for physical health over 18 months. To examine whether maintained importance of aspirations for physical health mediated and/or moderated the effect of an intensive intervention on long-term tobacco abstinence. Participants were randomly assigned to an intervention based on self-determination theory or to community care, and provided data at baseline and at 18 and 30 months post-randomization. Aspirations for physical health were better maintained over 18 months among participants in the intervention (mean change=.05), relative to community care (mean change=-.13), t=2.66, p<.01. Maintained importance of aspirations for physical health partially mediated the treatment condition effects on seven-day point prevalence tobacco abstinence (z'=1.68, p<.01) and the longest number of days not smoking (z'=2.16, p<.01), and interacted with treatment condition to facilitate the longest number of days not smoking (beta=.08, p<.05). Maintained importance of aspirations for physical health facilitated tobacco abstinence. Smokers may benefit from discussing aspirations for physical health within autonomy-supportive interventions. Patients may benefit from discussing aspirations during counseling about therapeutic lifestyle change and medication use.
External validity of randomized controlled trials in older adults, a systematic review.
van Deudekom, Floor J; Postmus, Iris; van der Ham, Danielle J; Pothof, Alexander B; Broekhuizen, Karen; Blauw, Gerard J; Mooijaart, Simon P
2017-01-01
To critically assess the external validity of randomized controlled trials (RCTs) it is important to know what older adults have been enrolled in the trials. The aim of this systematic review is to study what proportion of trials specifically designed for older patients report on somatic status, physical and mental functioning, social environment and frailty in the patient characteristics. PubMed was searched for articles published in 2012 and only RCTs were included. Articles were further excluded if not conducted with humans or only secondary analyses were reported. A random sample of 10% was drawn. The current review analyzed this random sample and further selected trials when the reported mean age was ≥ 60 years. We extracted geriatric assessments from the population descriptives or the in- and exclusion criteria. In total 1396 trials were analyzed and 300 trials included. The median of the reported mean age was 66 (IQR 63-70) and the median percentage of men in the trials was 60 (IQR 45-72). In 34% of the RCTs specifically designed for older patients somatic status, physical and mental functioning, social environment or frailty were reported in the population descriptives or the in- and exclusion criteria. Physical and mental functioning was reported most frequently (22% and 14%). When selecting RCTs on a mean age of 70 or 80 years the report of geriatric assessments in the patient characteristics was 46% and 85% respectively but represent only 5% and 1% of the trials. Somatic status, physical and mental functioning, social environment and frailty are underreported even in RCTs specifically designed for older patients published in 2012. Therefore, it is unclear for clinicians to which older patients the results can be applied. We recommend systematic to transparently report these relevant characteristics of older participants included in RCTs.
Schuster, Randi Melissa; Hanly, Ailish; Gilman, Jodi; Budney, Alan; Vandrey, Ryan; Evins, A Eden
2016-10-01
Rates of young adult cannabis use are rising, perceived harm is at its historical nadir, and most users do not want to quit. Most studies evaluating effects of cannabis use in young adults are cross-sectional, limiting causal inference. A method to reliably induce abstinence periods in cannabis users would allow assessment of the effects of abstinence and resumption of use on a variety of outcomes in a within-subjects, repeated measures design. We examined the efficacy and feasibility of a voucher-based contingency management procedure for incentivizing one month of continuous cannabis abstinence among young adults who reported at least weekly cannabis use, volunteered to participate in a laboratory study, and did not express a desire to discontinue cannabis use long-term. Continuous cannabis abstinence was reinforced with an escalating incentive schedule, and self-report of abstinence was confirmed by frequent quantitative assays of urine cannabis metabolite (THCCOOH) concentration. New cannabis use during the abstinence period was determined using an established algorithm of change in creatinine-adjusted cannabis metabolite concentrations between study visits. Thirty-eight young adults, aged 18-25 years, enrolled and 34 (89.5%) attained biochemically confirmed 30-day abstinence. Among those who attained abstinence, 93.9% resumed regular use within two-weeks of incentive discontinuation. Findings support the feasibility and efficacy of contingency management to elicit short-term, continuous cannabis abstinence among young adult, non-treatment seeking, regular cannabis users. Further work should test the effectiveness of this contingency management procedure for cannabis abstinence in periods longer than one month, which may be required to evaluate some effects of abstinence. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
Johnston, Jennifer; Lintzeris, Nicholas; Allsop, David J; Suraev, Anastasia; Booth, Jessica; Carson, Dean S; Helliwell, David; Winstock, Adam; McGregor, Iain S
2014-12-01
Preclinical studies suggest that lithium carbonate (lithium) can reduce precipitated cannabinoid withdrawal in rats by stimulating release of the neuropeptide oxytocin, while two open-label studies indicate lithium may ameliorate cannabis withdrawal symptoms in humans. This study was conducted to examine the efficacy and safety of lithium in the inpatient management of cannabis withdrawal and to determine whether lithium affects plasma oxytocin and the rate of elimination of plasma cannabinoids during abstinence. Treatment-seeking cannabis-dependent adults (n = 38) were admitted for 8 days to an inpatient withdrawal unit and randomized to either oral lithium (500 mg) or placebo given twice a day under double-blind randomized controlled trial (RCT) conditions. Primary outcomes included withdrawal severity [cannabis withdrawal scale (CWS)], rates of detoxification completion, and adverse events. Plasma cannabinoids, plasma oxytocin and serum lithium levels were measured repeatedly over admission. Follow-up research interviews were conducted at 14, 30, and 90 days postdischarge. Lithium did not significantly affect total CWS scores relative to placebo, although it significantly reduced individual symptoms of "loss of appetite," "stomach aches," and "nightmares/strange dreams." No significant group differences were found in treatment retention or adverse events. Lithium did not increase plasma oxytocin levels nor influence the rate of elimination of cannabinoids. Both placebo- and lithium-treated participants showed reduced levels of cannabis use (verified by urinalysis) and improved health and psychosocial outcomes at 30- and 90-day follow-up relative to pretreatment baselines. Despite the strong rationale for the present study, the efficacy of lithium over placebo in the management of cannabis withdrawal was not demonstrated.
Andersen, Kjeld; Bogenschutz, Michael P; Bühringer, Gerhard; Behrendt, Silke; Bilberg, Randi; Braun, Barbara; Ekstrøm, Claus Thorn; Forcehimes, Alyssa; Lizarraga, Christine; Moyers, Theresa B; Nielsen, Anette Søgaard
2015-11-14
The proportion of 60+ years with excessive alcohol intake varies in western countries between 6-16 % among men and 2-7 % among women. Specific events related to aging (e.g. loss of job, physical and mental capacity, or spouse) may contribute to onset or continuation of alcohol use disorders (AUD). We present the rationale and design of a multisite, multinational AUD treatment study for subjects aged 60+ years. 1,000 subjects seeking treatment for AUD according to DSM-5 in outpatient clinics in Denmark, Germany, and New Mexico (USA) are invited to participate in a RCT. Participants are randomly assigned to four sessions of Motivational Enhancement Treatment (MET) or to MET plus an add-on with eight sessions based on the Community Reinforcement Approach (CRA), which include a new module targeting specific problems of older adults. A series of assessment instruments is applied, including the Form-90, Alcohol Dependence Scale, Penn Alcohol Craving Scale, Brief Symptom Inventory and WHO Quality of Life. Enrolment will be completed by April 2016 and data collection by April 2017. The primary outcome is the proportion in each group who are abstinent or have a controlled use of alcohol six months after treatment initiation. Controlled use is defined as maximum blood alcohol content not exceeding 0.05 % during the last month. Total abstinence is a secondary outcome, together with quality of life andcompliance with treatment. The study will provide new knowledge about brief treatment of AUD for older subjects. As the treatment is manualized and applied in routine treatment facilities, barriers for implementation in the health care system are relatively low. Finally, as the study is being conducted in three different countries it will also provide significant insight into the possible interaction of service system differences and related patient characteristics in predictionof treatment outcome. Clinical Trials.gov NCT02084173 , March 7, 2014.
Schuster, Randi Melissa; Hanly, Ailish; Gilman, Jodi; Budney, Alan; Vandrey, Ryan; Evins, A. Eden
2016-01-01
Background Rates of young adult cannabis use are rising, perceived harm is at its historical nadir, and most users do not want to quit. Most studies evaluating effects of cannabis use in young adults are cross-sectional, limiting causal inference. A method to reliably induce abstinence periods in cannabis users would allow assessment of the effects of abstinence and resumption of use on a variety of outcomes in a within subjects, repeated measure design. Methods We examined the efficacy and feasibility of a voucher-based contingency management procedure for incentivizing one month of continuous cannabis abstinence among young adults who reported at least weekly cannabis use, volunteered to participate in a laboratory study, and did not express desire to discontinue cannabis use long-term. Continuous cannabis abstinence was reinforced with an escalating incentive schedule, and self-report of abstinence was confirmed by frequent quantitative assays of urine cannabis metabolite (THCCOOH) concentration. New cannabis use during the abstinence period was determined using an established algorithm of change in creatinine-adjusted cannabis metabolite concentration between study visits. Results Thirty-eight young adults, aged 18–25, enrolled and 34 (89.5%) attained biochemically confirmed 30-day abstinence. Among those who attained abstinence, 93.9% resumed regular use within two-weeks of incentive discontinuation. Conclusion Findings support the feasibility and efficacy of contingency management to elicit short-term, continuous cannabis abstinence among young adult, non-treatment-seeking, regular cannabis users. Further work should test the effectiveness of this CM procedure for cannabis abstinence periods longer than one month, which may be required to evaluate some effects of abstinence. PMID:27590742
Wangberg, Silje C; Nilsen, Olav; Antypas, Konstantinos; Gram, Inger Torhild
2011-12-15
Studies suggest that tailored materials are superior to nontailored materials in supporting health behavioral change. Several trials on tailored Internet-based interventions for smoking cessation have shown good effects. There have, however, been few attempts to isolate the effect of the tailoring component of an Internet-based intervention for smoking cessation and to compare it with the effectiveness of the other components. The study aim was to isolate the effect of tailored emails in an Internet-based intervention for smoking cessation by comparing two versions of the intervention, with and without tailored content. We conducted a two-arm, randomized controlled trial of the open and free Norwegian 12-month follow-up, fully automated Internet-based intervention for smoking cessation, slutta.no. We collected information online on demographics, smoking, self-efficacy, use of the website, and participant evaluation at enrollment and subsequently at 1, 3, and 12 months. Altogether, 2298 self-selected participants aged 16 years or older registered at the website between August 15, 2006 and December 7, 2007 and were randomly assigned to either a multicomponent, nontailored Internet-based intervention for smoking cessation (control) or a version of the same Internet-based intervention with tailored content delivered on the website and via email. Of the randomly assigned participants, 116 (of 419, response rate = 27.7%) in the intervention group and 128 (of 428, response rate = 29.9%) in the control group had participated over the 12 months and responded at the end of follow-up. The 7-day intention-to-treat abstinence rate at 1 month was 15.2% (149/982) among those receiving the tailored intervention, compared with 9.4% (94/999) among those who received the nontailored intervention (P < .001). The corresponding figures at 3 months were 13.5% (122/902) and 9.4% (84/896, P =.006) and at 12 months were 11.2% (47/419) and 11.7% (50/428, P = .91). Likewise, the intervention
Financial Management of a Large Multi-site Randomized Clinical Trial
Sheffet, Alice J.; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E.; Longbottom, Mary E.; Howard, Virginia J.; Marler, John R.; Brott, Thomas G.
2014-01-01
Background The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years’ funding ($21,112,866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2,500 randomized participants at 40 sites. Aims Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Methods Projections of the original grant’s fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant’s fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Results Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2,500 targeted sample size, 138 (5.5%) were randomized during the first five years and 1,387 (55.5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13,845) of the projected per-patient costs ($152,992) of the fixed model. Conclusions Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. PMID:24661748
Testing a Violence-Prevention Intervention for Incarcerated Women Using a Randomized Control Trial
ERIC Educational Resources Information Center
Kubiak, Sheryl Pimlott; Kim, Woo Jong; Fedock, Gina; Bybee, Deborah
2015-01-01
Objective: Beyond Violence (BV), a new prevention program for women with assaultive offenses, demonstrated feasibility in previous studies. This study's purpose is to assess the efficacy of BV using a randomized control trial. Method: Eligible women were randomly assigned to treatment as usual (TAU) and the experimental condition (BV). Measures of…
Wijeysundera, Duminda N; Austin, Peter C; Hux, Janet E; Beattie, W Scott; Laupacis, Andreas
2009-01-01
Randomized trials generally use "frequentist" statistics based on P-values and 95% confidence intervals. Frequentist methods have limitations that might be overcome, in part, by Bayesian inference. To illustrate these advantages, we re-analyzed randomized trials published in four general medical journals during 2004. We used Medline to identify randomized superiority trials with two parallel arms, individual-level randomization and dichotomous or time-to-event primary outcomes. Studies with P<0.05 in favor of the intervention were deemed "positive"; otherwise, they were "negative." We used several prior distributions and exact conjugate analyses to calculate Bayesian posterior probabilities for clinically relevant effects. Of 88 included studies, 39 were positive using a frequentist analysis. Although the Bayesian posterior probabilities of any benefit (relative risk or hazard ratio<1) were high in positive studies, these probabilities were lower and variable for larger benefits. The positive studies had only moderate probabilities for exceeding the effects that were assumed for calculating the sample size. By comparison, there were moderate probabilities of any benefit in negative studies. Bayesian and frequentist analyses complement each other when interpreting the results of randomized trials. Future reports of randomized trials should include both.
Beyond the Randomized Controlled Trial: A Review of Alternatives in mHealth Clinical Trial Methods
Wiljer, David; Cafazzo, Joseph A
2016-01-01
Background Randomized controlled trials (RCTs) have long been considered the primary research study design capable of eliciting causal relationships between health interventions and consequent outcomes. However, with a prolonged duration from recruitment to publication, high-cost trial implementation, and a rigid trial protocol, RCTs are perceived as an impractical evaluation methodology for most mHealth apps. Objective Given the recent development of alternative evaluation methodologies and tools to automate mHealth research, we sought to determine the breadth of these methods and the extent that they were being used in clinical trials. Methods We conducted a review of the ClinicalTrials.gov registry to identify and examine current clinical trials involving mHealth apps and retrieved relevant trials registered between November 2014 and November 2015. Results Of the 137 trials identified, 71 were found to meet inclusion criteria. The majority used a randomized controlled trial design (80%, 57/71). Study designs included 36 two-group pretest-posttest control group comparisons (51%, 36/71), 16 posttest-only control group comparisons (23%, 16/71), 7 one-group pretest-posttest designs (10%, 7/71), 2 one-shot case study designs (3%, 2/71), and 2 static-group comparisons (3%, 2/71). A total of 17 trials included a qualitative component to their methodology (24%, 17/71). Complete trial data collection required 20 months on average to complete (mean 21, SD 12). For trials with a total duration of 2 years or more (31%, 22/71), the average time from recruitment to complete data collection (mean 35 months, SD 10) was 2 years longer than the average time required to collect primary data (mean 11, SD 8). Trials had a moderate sample size of 112 participants. Two trials were conducted online (3%, 2/71) and 7 trials collected data continuously (10%, 7/68). Onsite study implementation was heavily favored (97%, 69/71). Trials with four data collection points had a longer study
Beyond the Randomized Controlled Trial: A Review of Alternatives in mHealth Clinical Trial Methods.
Pham, Quynh; Wiljer, David; Cafazzo, Joseph A
2016-09-09
Randomized controlled trials (RCTs) have long been considered the primary research study design capable of eliciting causal relationships between health interventions and consequent outcomes. However, with a prolonged duration from recruitment to publication, high-cost trial implementation, and a rigid trial protocol, RCTs are perceived as an impractical evaluation methodology for most mHealth apps. Given the recent development of alternative evaluation methodologies and tools to automate mHealth research, we sought to determine the breadth of these methods and the extent that they were being used in clinical trials. We conducted a review of the ClinicalTrials.gov registry to identify and examine current clinical trials involving mHealth apps and retrieved relevant trials registered between November 2014 and November 2015. Of the 137 trials identified, 71 were found to meet inclusion criteria. The majority used a randomized controlled trial design (80%, 57/71). Study designs included 36 two-group pretest-posttest control group comparisons (51%, 36/71), 16 posttest-only control group comparisons (23%, 16/71), 7 one-group pretest-posttest designs (10%, 7/71), 2 one-shot case study designs (3%, 2/71), and 2 static-group comparisons (3%, 2/71). A total of 17 trials included a qualitative component to their methodology (24%, 17/71). Complete trial data collection required 20 months on average to complete (mean 21, SD 12). For trials with a total duration of 2 years or more (31%, 22/71), the average time from recruitment to complete data collection (mean 35 months, SD 10) was 2 years longer than the average time required to collect primary data (mean 11, SD 8). Trials had a moderate sample size of 112 participants. Two trials were conducted online (3%, 2/71) and 7 trials collected data continuously (10%, 7/68). Onsite study implementation was heavily favored (97%, 69/71). Trials with four data collection points had a longer study duration than trials with two data
A randomized trial of blood donor recruitment strategies.
Reich, Pascale; Roberts, Paula; Laabs, Nancy; Chinn, Artina; McEvoy, Patrick; Hirschler, Nora; Murphy, Edward L
2006-07-01
Improvement in donor return rates, especially among first-time donors, may significantly improve the blood supply. There are few rigorous studies of the effectiveness of various approaches to donor recruitment, however. By use of a single-blind, randomized trial design, 6919 post-September 11, 2001, first-time donors were randomly assigned into the following intervention arms: T-shirt incentive versus none, recruitment scripts with a patient story (Script A) versus a complimentary message including the donor's blood type (Script B), and telephone versus e-mail recruitment. Our primary outcome was a second donation within 6 months. Rate ratios (RRs) and 95 percent confidence intervals (95% CIs) were calculated with Taylor series methods. A total of 1421 (20.5%) first-time donors returned within the 6 months, including 1252 with a second and 169 with both second and third donations. The T-shirt incentive was not effective in increasing returns compared to no incentive (20.5% vs. 20.6%; RR, 0.99; 95% CI, 0.91-1.09). Script A was significantly more effective than Script B (22.2% vs. 18.9%; RR, 1.18; 95% CI, 1.07-1.29). E-mail was substantially less effective than telephone recruitment (13.2% vs. 27.8%; RR, 0.48; 95% CI, 0.40-0.57). A T-shirt incentive had no apparent effect, but an empathetic message significantly improved the return donation rate. E-mail recruitment was substantially less effective than telephone recruitment, perhaps due to technical problems. The study illustrates the utility of the randomized clinical trial study design for testing donor recruitment strategies.
Dickson-Spillmann, Maria; Haug, Severin; Schaub, Michael P
2013-12-23
Despite the popularity of hypnotherapy for smoking cessation, the efficacy of this method is unclear. We aimed to investigate the efficacy of a single-session of group hypnotherapy for smoking cessation compared to relaxation in Swiss adult smokers. This was a cluster-randomised, parallel-group, controlled trial. A single session of hypnosis or relaxation for smoking cessation was delivered to groups of smokers (median size = 11). Participants were 223 smokers consuming ≥ 5 cigarettes per day, willing to quit and not using cessation aids (47.1% females, M = 37.5 years [SD = 11.8], 86.1% Swiss). Nicotine withdrawal, smoking abstinence self-efficacy, and adverse reactions were assessed at a 2-week follow-up. The main outcome, self-reported 30-day point prevalence of smoking abstinence, was assessed at a 6-month follow up. Abstinence was validated through salivary analysis. Secondary outcomes included number of cigarettes smoked per day, smoking abstinence self-efficacy, and nicotine withdrawal. At the 6-month follow up, 14.7% in the hypnosis group and 17.8% in the relaxation group were abstinent. The intervention had no effect on smoking status (p = .73) or on the number of cigarettes smoked per day (p = .56). Smoking abstinence self-efficacy did not differ between the interventions (p = .14) at the 2-week follow-up, but non-smokers in the hypnosis group experienced reduced withdrawal (p = .02). Both interventions produced few adverse reactions (p = .81). A single session of group hypnotherapy does not appear to be more effective for smoking cessation than a group relaxation session. Current Controlled Trials ISRCTN72839675.
Withdrawal-Related Changes in Delay Discounting Predict Short-Term Smoking Abstinence.
Miglin, Rickie; Kable, Joseph W; Bowers, Maureen E; Ashare, Rebecca L
2017-06-01
Impulsive decision making is associated with smoking behavior and reflects preferences for smaller, immediate rewards and intolerance of temporal delays. Nicotine withdrawal may alter impulsive decision making and time perception. However, little is known about whether withdrawal-related changes in decision making and time perception predict smoking relapse. Forty-five smokers (14 female) completed two laboratory sessions, one following 24-hour abstinence and one smoking-as-usual (order counterbalanced; biochemically verified abstinence). During each visit, participants completed measures of time perception, decision making (ie, discount rates), craving, and withdrawal. Following the second laboratory session, subjects underwent a well-validated model of short-term abstinence (quit week) with small monetary incentives for each day of biochemically confirmed abstinence. Smokers significantly overestimated time during abstinence, compared to smoking-as-usual (p = .021), but there were no abstinence effects on discount rates (p = .6). During the quit week, subjects were abstinent for 3.5 days (SD = 2.15) and smoked a total of 12.9 cigarettes (SD = 15.8). Importantly, higher discount rates (ie, preferences for immediate rewards) during abstinence (abstinence minus smoking difference score) predicted greater number of days abstinent (p = .01) and fewer cigarettes smoked during the quit week (p = .02). Withdrawal-related change in time reproduction did not predict relapse (p = .2). These data suggest that individuals who have a greater preference for immediate rewards during abstinence (vs. smoking-as-usual) may be more successful at maintaining short-term abstinence when provided with frequent (eg, daily) versus less frequent incentive schedules (eg, 1 month). Abstinence-induced changes in decision making may be important for identifying smokers who may benefit from interventions that incentivize abstinence such as contingency management (CM). The present results
2013-01-01
Background Organic nitrates uncouple bone turnover, improve bone mineral density, and improve trabecular and cortical components of bone. These changes in turnover, strength and geometry may translate into an important reduction in fractures. However, before proceeding with a large fracture trial, there is a need to identify the nitrate formulation that has both the greatest efficacy (with regards to bone turnover markers) and gives the fewest headaches. Ascertaining which nitrate formulation this may be is the purpose of the current study. Methods and design This will be an open-label randomized, controlled trial conducted at Women’s College Hospital comparing five formulations of nitrates for their effects on bone turnover markers and headache. We will recruit postmenopausal women age 50 years or older with no contraindications to nitroglycerin. Our trial will consist of a run-in phase and a treatment phase. We will enroll 420 women in the run-in phase, each to receive all of the 5 potential treatments in random order for 2 days, each with a 2-day washout period between treatments. Those who tolerate all formulations will enter the 12-week treatment phase and be randomly assigned to one of five groups: 0.3 mg sublingual nitroglycerin tablet, 0.6 mg of the sublingual tablet, a 20 mg tablet of isosorbide mononitrate, a 160 mg nitroglycerin transdermal patch (used for 8 h), and 15 mg of nitroglycerin ointment as used in a previous trial by our group. We will continue enrolment until we have randomized 210 women or 35 women per group. Concentrations of bone formation (bone-specific alkaline phosphatase and procollagen type I N-terminal propeptide) and bone resorption (C-telopeptides of collagen crosslinks and N-terminal crosslinks of collagen) agents will be measured in samples taken at study entry (the start of the run in phase) and 12 weeks. Subjects will record the frequency and severity of headaches daily during the run-in phase and then monthly after that. We
A contingent payment model of smoking cessation: effects on abstinence and withdrawal.
Heil, Sarah H; Tidey, Jennifer W; Holmes, Heather W; Badger, Gary J; Higgins, Stephen T
2003-04-01
The present study was designed to characterize nicotine withdrawal during a 5-day period in which smokers who were not trying to quit were offered monetary incentives to abstain while residing in their usual environments. Participants were randomly assigned to one of three groups. In two groups, monetary payment was delivered contingent on breath carbon monoxide levels (CO< or =8 ppm) indicating recent smoking abstinence, with the amount of payment differing between the two groups. The third group was a control group in which payment was delivered independent of smoking status. Participants provided CO samples three times per day (morning, afternoon- and evening) for 5 days (Monday-Friday). At each evening visit, all participants completed a nicotine withdrawal questionnaire and other questionnaires. Contingent payment significantly decreased expired-air CO and salivary cotinine levels as compared with the control group. No significant differences in abstinence were noted as a function of the amount paid. Participants in both contingent payment groups reported significantly more withdrawal symptoms than those in the noncontingent control group, including increases in anxiety and nervousness, impatience and restlessness, hunger, and desire to smoke. Such contingent payment procedures may provide an effective method for studying nicotine withdrawal in smokers that does not require the costly and inconvenient practice of housing research participants on a closed ward to prevent smoking.
ERIC Educational Resources Information Center
Ludman, Evette J.; Simon, Gregory E.; Tutty, Steve; Von Korff, Michael
2007-01-01
Randomized trial evidence and expert guidelines are mixed regarding the value of combined pharmacotherapy and psychotherapy as initial treatment for depression. This study describes long-term results of a randomized trial (N = 393) evaluating telephone-based cognitive-behavioral therapy (CBT) plus care management for primary care patients…
Social Influences on Abstinence Self-Efficacy among Justice-Involved Persons
Majer, John M.; Callahan, Sarah; Stevick, Kate; Jason, Leonard A.
2016-01-01
Social influences (social support for alcohol/drug use and social support for abstinence) were examined in relation to abstinence self-efficacy among a sample of 250 justice involved persons exiting inpatient treatment for substance use disorders. Hierarchical linear regression was used to examine social influences in relation to abstinence self-efficacy. Social influences were significantly related to abstinence self-efficacy when examined independently. However, only social support for alcohol/drug use was significant when both social influences were entered into the model. Findings suggest social support for alcohol/drug use compromises abstinence social support, particularly among justice involved persons who are early in their recovery from substance use disorders. PMID:27594810