Varenicline Treatment for Active Alcoholic Smokers
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
Alcohol dependence is a significant and prevalent public health problem affecting
approximately 4% of the U.S. adult population. Individuals with alcohol dependence actively
seek treatment annually, and long-term alcohol abstinence varies from 40-60%. Because of the
high smoking prevalence and trends toward heavier smoking, alcoholic smokers are at high risk
for both morbidity and mortality related to alcohol consumption and tobacco dependence.
Although several studies have evaluated pharmacotherapy for tobacco dependence in recovering
alcoholic smokers, few have evaluated pharmacotherapy for tobacco dependence among currently
drinking alcoholic smokers.
Varenicline is the most effective medication currently available for treating tobacco
dependence. While some randomized trials have included recovering alcoholics, active
alcoholism has been an exclusion criteria for these trials. Thus, this proposal would be the
first such clinical trial in currently drinking alcoholic smokers. In addition to helping
smokers to stop smoking, varenicline has also been shown to reduce alcohol consumption in
rats. The goal of this proposal is to explore the potential efficacy of varenicline for
treating tobacco dependence and reducing drinking among alcohol dependent smokers.
The investigators hypothesize that 12 weeks of treatment with varenicline, a partial
nicotinic acetylcholine receptor agonist will be more effective than placebo in treating
tobacco dependence and reducing nicotine withdrawal symptoms in currently drinking alcoholic
smokers. The investigators will also explore whether varenicline has an effect on drinking
behavior among currently drinking alcoholics. The investigators propose the following
specific aims to test these hypotheses in 70 currently drinking alcoholic smokers recruited
at the Mayo Clinic in Rochester, Minnesota.