Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence
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|ClinicalTrials.gov Identifier: NCT00304707|
Recruitment Status : Completed
First Posted : March 20, 2006
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation Alcohol-Related Disorders||Drug: Bupropion Drug: placebo||Phase 3|
Past research suggests that over 75% of alcohol dependent individuals in early alcohol recovery smoke cigarettes; smoking-related mortality exceeds alcohol-related mortality in this population. Many alcohol dependent individuals in early recovery are interested in smoking cessation treatment; however, studies indicate that these smokers find it very difficult to quit smoking. More effective treatment methods are needed for smokers in early alcohol recovery. Bupropion is a dopaminergic antidepressant that may be effective in treating nicotine dependent individuals. The purpose of this study is to evaluate the effectiveness of bupropion in nicotine dependent individuals receiving treatment for alcohol dependence. In addition, this study will investigate the psychological mechanisms that may mediate the efficacy of bupropion in smoking cessation. We will also collect DNA from subjects in order to explore whether response to bupropion is mediated by particular genetic variants in the dopaminergic, metabolic and nicotinic receptor systems of smokers.
Participants will be randomly assigned to receive either 300 mg of bupropion or placebo, daily for 8 weeks. In addition, all participants will receive a nicotine patch for 7 weeks. This will consist of a 21-mg nicotine patch for 4 weeks, a 14-mg nicotine patch for 2 weeks, and a 7-mg nicotine patch for 1 week. All participants will undergo seven counseling sessions. Follow-up visits will occur at Weeks 7, 12, and 24. Pre-quit variables (e.g., smoking satisfaction) and three post-quit variables (craving, nicotine withdrawal, and negative effects) will be evaluated at all study visits.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||143 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Bupropion Treatment for Smokers in Recovery|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2011|
participants in this arm receive bupropion
300 mg QD
Placebo Comparator: 1
- Smoking Abstinence [ Time Frame: week 7, week 11 and week 24 after scheduled quit day ]The number of subjects in each treatment group who were smoking abstinent (7-day point prevalence) at week 7 (end of treatment), week 11 and week 24.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304707
|United States, Massachusetts|
|ENRM Veterans Hospital|
|Bedford, Massachusetts, United States, 01730|
|Principal Investigator:||David Kalman, PhD||Boston University|