Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence

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.

Inclusion Criteria:

- Smokes a minimum of 10 cigarettes daily for at least 1 year prior to study entry

- Abstinence from alcohol and other non-nicotine drugs for between 1 and 12 months at
time of study entry

- Meets criteria for alcohol dependence or abuse in the 12 months prior to study entry

Exclusion Criteria:

- History of seizures, head trauma and/or severe hepatic cirrhosis

- Current use of medications known to affect smoking behavior and/or cessation

- Use of tricyclic antidepressant medication and monoamine oxidase inhibitors

- Major depressive disorder within the month prior to study entry

- Eating disorder within the year prior to study entry

- History of bipolar or psychotic disorder

- Pregnant or breastfeeding

- Unstable serious medical disorder

- History of migraines

- Currently using smokeless tobacco, pipes, or cigars