Clinical Trial: Varenicline to Reduce Alcohol Consumption in Heavy Drinkers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-blind, Placebo Controlled Trial (RCT) of Varenicline to Reduce Alcohol Consumption in Heavy Drinkers

Brief Summary:

This study will determine whether varenicline, a drug that acts on the brain's nicotine receptors and is used to help smokers stop smoking, will have an impact on alcohol self-administration.

People between 24 and 60 years of age who regularly consume alcoholic drinks (more than 15 drinks per week for women, and more than 20 drinks per week for men) may be eligible for this study. The study requires five outpatient visits and one overnight hospital admission at the NIH Clinical Center.

Participants undergo the following procedures:

Visit 1 (outpatient: 4-5 hours)

Standard assessments, including vital signs measurements, breathalyzer test, blood and urine tests (including pregnancy test for females), questionnaires about mood, symptoms, alcohol use and smoking, if applicable
Questionnaires about medical and psychological status
Health assessment and assessment of alcohol drinking behavior

Visit 2 (outpatient: 8 hours)

Standard assessments (see above)
Computer-Assisted Self-infusion of Ethanol (CASE) session: Subjects will receive a priming intravenous infusion of alcohol. After 25 min, they will be allowed to give themselves additional exposures of alcohol over a period of 2 hours by pressing a button on a computer that controls the infusion pump.

Visit 3 (outpatient: 2 hours)

-Standard assessments