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A Randomized Trial Evaluating Whether Topiramate Aids Smoking Cessation and Prevents Alcohol Relapse in Recovering Alcohol-Dependent Men.

ABSTRACT: BACKGROUND:Alcohol and nicotine dependence frequently co-occur, and quitting smoking might enhance long-term alcohol abstinence. Topiramate appears to help non-alcohol-dependent individuals quit smoking, and our pilot work suggested efficacy only in men. It also prevents relapse to alcohol in recently detoxified alcoholics. We evaluated topiramate in abstinent alcohol-dependent men to assess whether this medication (i) promotes smoking cessation and (ii) prevents alcohol and other drug relapse in the context of smoking cessation treatment. METHODS:One hundred and twenty-nine alcohol-abstinent (mean ~6 months) alcohol-dependent male smokers (80% with other substance use disorders) participated in this 12-week randomized, double blind, parallel group comparison of topiramate (up to 200 mg/d) and placebo with a 24-week nontreatment follow-up period. The study was carried out sequentially at 2 academic centers in the Midwest and Southern California between March 23, 2009 and November 20, 2014. All participants received manual-guided smoking cessation counseling combined with medication-focused compliance enhancement therapy. Randomization was block designed by the research pharmacist in a 1:1 ratio. Participants, investigators, and research personnel were masked to treatment assignment. The primary smoking end point was biochemically confirmed 4-week continuous abstinence from smoking during weeks 9 to 12, while the secondary end point was relapse to any drinking or drug use during the entire 36-week evaluation period. Logistic regression was used to determine the effects of topiramate on quitting smoking and alcohol relapse, controlling for relevant covariates. The trial is registered at ClinicalTrials.gov (number NCT00802412) and is now closed. RESULTS:Only a small proportion (7.9%) of topiramate-treated participants were able to quit smoking, and this cessation rate was similar to placebo (10.6%; odds ratio = 1.60; 95% confidence interval 0.4, 6.5; p = 0.51). Roughly 30% of the sample had a documented relapse to drinking or drug use during the study, and these rates were similar in the topiramate (20/63; 31.8%) and placebo groups (18/66; 27.3%; p = 0.58). Results of a longitudinal logistic regression model examining time to any alcohol relapse revealed no medication effect. CONCLUSIONS:Topiramate at a daily dosage of up to 200 mg per day, combined with smoking cessation and medication adherence counseling, had no effects on smoking cessation or the prevention of alcohol or drug relapse in male smokers who were in early or sustained full remission from alcohol and motivated to make a quit attempt. Alternative approaches for treating this high-risk, dually dependent population are needed.

SUBMITTER: Anthenelli RM

PROVIDER: S-EPMC5310526 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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A Randomized Trial Evaluating Whether Topiramate Aids Smoking Cessation and Prevents Alcohol Relapse in Recovering Alcohol-Dependent Men.

Anthenelli Robert M RM Heffner Jaimee L JL Wong Esther E Tibbs Jessie J Russell Katie K Isgro Melodie M Dinh Elizabeth E Wehrle Chris C Worley Matthew J MJ Doran Neal N

Alcoholism, clinical and experimental research 20161228 1

<h4>Background</h4>Alcohol and nicotine dependence frequently co-occur, and quitting smoking might enhance long-term alcohol abstinence. Topiramate appears to help non-alcohol-dependent individuals quit smoking, and our pilot work suggested efficacy only in men. It also prevents relapse to alcohol in recently detoxified alcoholics. We evaluated topiramate in abstinent alcohol-dependent men to assess whether this medication (i) promotes smoking cessation and (ii) prevents alcohol and other drug r ...[more]

PMID: 28029173

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Project description:BackgroundNicotine addiction through cigarette use is highly prevalent among individuals suffering from alcohol and other drug (AOD) problems and remains a prominent risk factor for morbidity, mortality, and healthcare utilization. Whereas most people agree that providing smoking cessation services (SCS) to this vulnerable population is vitally important, the timing of such service provision has been hotly debated, including whether such services should be excluded, available (but not offered), offered, or fully integrated into AOD treatment settings. Important stakeholders in this debate are those in recovery from AOD problems who, in addition to having often been AOD treatment patients themselves, frequently hold influential clinical, research or policy positions and thus can influence the likelihood of SCS provision. This study sought to understand the attitudes of this important stakeholder group in providing SCS in AOD treatment settings.MethodWe assessed a national cross-sectional sample of individuals in recovery from an AOD problem (n = 1973) on whether SCS should be: a. excluded; b. available; c. offered; or d. integrated into AOD services. We estimated associations between participants' demographic, clinical, and recovery support service use history, and SCS attitude variables, using multinomial logistic regression.ResultsRoughly equal proportions endorsed each attitudinal position (23.5% excluded, 25% available, 24.6% offered; 26.9% integrated). Correlates of holding more positive SCS implementation attitudes were Black race; primary substance other than alcohol, greater intensity of former or recent smoking, and less mutual-help organization participation; older individuals achieving recovery between 30 and 40 years ago also had more positive attitudes toward integrating SCS.ConclusionsAbout half of those sampled were either against SCS inclusion in AOD settings or were in favor of making it "available" only, but not in offering it or integrating it. This oppositional pattern was accentuated particularly among those with primary alcohol problem histories and those participating in mutual-help organizations. Given the universally well-known negative health effects of smoking, understanding more about the exact reasons why certain groups of recovering persons may endorse such positions is an area worthy of further investigation, as it may uncover potential barriers to SCS implementation in AOD treatment settings.

Project description:Background and aimsUnderstanding whether and how far smokers' characteristics influence the effectiveness of treatment may be important for tailoring recommendations on cessation aids to those most likely to help the user achieve abstinence. This study aimed to estimate the effectiveness of commonly used smoking cessation aids and test whether their effectiveness differs according to cigarette addiction, socio-economic status, age or sex.DesignCorrelational design using cross-sectional survey data collected monthly between 2006 and 2018.SettingEngland.ParticipantsA total of 18 929 adults (aged ≥ 16 years, 52.0% female) who had smoked within the previous 12 months and had made at least one quit attempt during that period.MeasurementsThe outcome was self-reported abstinence from quit date to survey. Independent variables were self-reported use during the most recent quit attempt of: prescription nicotine replacement therapy (NRT), NRT over-the-counter, varenicline, bupropion, e-cigarettes, face-to-face behavioural support, telephone support, written self-help materials, websites and hypnotherapy. Moderators were cigarette addiction, social grade, age and sex.FindingsAfter adjustment for covariates and use of other cessation aids, users of e-cigarettes [odds ratio (OR) = 1.95, 95% confidence interval (CI) = 1.69-2.24] and varenicline (OR = 1.82, 95% CI = 1.51-2.21) had significantly higher odds of reporting abstinence than those who did not report use of these cessation aids. Use of prescription NRT was associated with increased abstinence in older (≥ 45 years) (OR = 1.58, 95% CI = 1.25-2.00) but not younger (< 45 years) smokers (OR = 1.09, 95% CI = 0.85-1.42). Use of websites was associated with increased abstinence in smokers from lower (OR = 2.20, 95% CI = 1.22-3.98) but not higher social grades (OR = 0.74, 95% CI = 0.40-1.38). There was little evidence of benefits of using other cessation aids.ConclusionsUse of e-cigarettes and varenicline are associated with higher abstinence rates following a quit attempt in England. Use of prescription of nicotine replacement therapy is also associated with higher abstinence rates, but only in older smokers, and use of websites only in smokers from lower socio-economic status.

Dataset Information

A Randomized Trial Evaluating Whether Topiramate Aids Smoking Cessation and Prevents Alcohol Relapse in Recovering Alcohol-Dependent Men.

Publications

A Randomized Trial Evaluating Whether Topiramate Aids Smoking Cessation and Prevents Alcohol Relapse in Recovering Alcohol-Dependent Men.

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