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

Vi

Detailed Summary:

Objective:

Considerable clinical and experimental evidence in humans and animal models links nicotine use with heavy alcohol consumption. Varenicline, an alpha4beta2 (nicotinic) acetylcholine receptor (nAchR) partial agonist, is an oral medication approved by the FDA (2006) for smoking cessation. Recently, it has been shown to reduce alcohol consumption in a rodent model of alcohol dependence. In the present short-term experimental study, it will be assessed primarily for its ability to reduce alcohol self-administration in heavy drinkers. Secondarily, its effects on alcohol urges (cravings), as well as smoking parameters will be measured. In addition, effects of varenicline on incentive motivation for alcohol and the underlying brain reward system activation, as well as on activation of brain reward systems in response to intravenously administered alcohol will be measured.

Study Population:

Fifty healthy, adults (smokers and non-smokers), age 21 to 60 years, will be studied. Individuals must drink alcohol regularly at a heavy level, on average greater than 20 drinks per week for men, and greater than 15 drinks per week for women, and not be seeking help for alcohol-related problems.

Design:

Following protocol screening and medical evaluation, qualified subjects will undergo an initial ( pre-study drug ) intravenous alcohol self-administration session (hereafter, called computer-assisted self-infusion of ethanol, or CASE). Following this, subjects will be randomized to varenicline or placebo. Subjects will be clinically evaluated on three occasions while on study drug: once after one week of study medication; again, prior to the fMRI; and again, at the end of treatment, when
Sponsor: Vijay Ramchandani, Ph.D.

Current Primary Outcome: Alcohol Consumption [ Time Frame: 2.5 hr session following 3 weeks of treatment ]

Original Primary Outcome: Alcohol Consumption

Current Secondary Outcome: Alcohol Urges [ Time Frame: 2.5 hr session following 3 weeks of treatment ]

Original Secondary Outcome:

Information By: National Institutes of Health Clinical Center (CC)

Dates:
Date Received: June 11, 2008
Date Started: June 2008
Date Completion:
Last Updated: July 5, 2016
Last Verified: July 2016