Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence

Status Recruiting

Clinical Trial Summary

Smoking is often a problem for alcohol dependent individuals. Many people who seek treatment for alcohol dependence are unable to quit smoking. The purpose of this study is to evaluate the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving treatment for alcohol dependence.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00304707
Study type	Interventional
Source	National Institute on Drug Abuse (NIDA)
Contact	David Kalman, PhD
Phone	781-687-3019
Email	david.kalman@va.gov
Status	Recruiting
Phase	Phase 3
Start date	April 2005
Completion date	February 2010

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.