The objective of this proposed Columbia-Yale collaborative project is to test the efficacy of varenicline for the treatment of alcohol dependenc among individuals who also report daily cigarette smoking. Alcohol dependent smokers have poorer alcoholism treatment outcomes and experience greater morbidity and mortality than alcohol dependent nonsmokers. The strong association between smoking and alcohol dependence suggests that common underlying factors may provide a therapeutic target for alcohol and nicotine use. Nicotinic acetylcholine receptors are the primary target of nicotine, and these receptors are involved in alcohol dependence. Varenicline is a partial nicotinic acetylcholine receptor antagonist with documented efficacy for smoking cessation. Varenicline also shows promise as a potential treatment for alcohol dependence based on preclinical models and recent human preliminary studies in heavy drinking smokers. Research conducted at Yale found that varenicline substantially reduces alcohol craving and drinking (compared to placebo) in a laboratory-alcohol administration paradigm and in a 3-week placebo controlled preliminary study. Based on these promising findings, the proposed study is a collaborative RO1 Phase II randomized double-blind placebo controlled 16-week study of varenicline for the treatment of alcohol drinking among 160 alcohol dependent daily smokers recruited at Yale and Columbia. The primary hypothesis is that varenicline will significantly reduce the percentage of heavy drinking days during the last two months of the treatment period. A secondary aim is to test the hypothesis that varenicline will promote smoking abstinence among alcohol dependent individuals who are not seeking smoking cessation counseling. Other secondary aims are to evaluate the effects of varenicline on alcohol and tobacco craving and the maintenance of change up through one-year. Finally, exploratory analyses will be conducted of moderators and mediators of varenicline effects. The combined recruitment resources and expertise of Yale and Columbia will advance the goals of the project. The potential benefits of varenicline, if confirmed, would represent a significant advance for the treatment of alcohol dependent smokers.

Public Health Relevance

Alcohol dependent smokers have poorer alcoholism treatment outcomes and experience greater morbidity and mortality than alcohol dependent nonsmokers. Varenicline, which has documented efficacy for smoking cessation, also shows promise as a potential treatment for alcohol dependence based on preclinical models and recent human preliminary studies in heavy drinking smokers. The potential benefits of varenicline, if confirmed by our proposed study, would represent a significant advance for the treatment of alcohol dependent smokers.

Agency
National Institute of Health (NIH)
Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Type
Research Project (R01)
Project #
1R01AA020388-01A1
Application #
8236503
Study Section
Health Services Research Review Subcommittee (AA)
Program Officer
Roach, Deidra
Project Start
2012-03-05
Project End
2016-02-29
Budget Start
2012-03-05
Budget End
2013-02-28
Support Year
1
Fiscal Year
2012
Total Cost
$528,887
Indirect Cost
$209,960
Name
Yale University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520