Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence
|Smoking Cessation Alcohol-Related Disorders||Drug: Bupropion Drug: placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Bupropion Treatment for Smokers in Recovery|
- 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.
|Study Start Date:||April 2005|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
participants in this arm receive bupropion
300 mg QD
Placebo Comparator: 1
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304707
|United States, Massachusetts|
|ENRM Veterans Hospital|
|Bedford, Massachusetts, United States, 01730|
|Principal Investigator:||David Kalman, PhD||Boston University|