This study will examine whether Rimonabant, a drug that blocks cannabinoid-1 (CB1) receptors
in the brain, affects alcohol consumption. Substances called endocannabinoids, which have
many of the same effects of marijuana, bind to CB1 receptors. Animal studies show that when
CB1 receptors are blocked, the animals consume less alcohol.
Healthy normal volunteers between 21 and 40 years of age who consume between 20 and 40
alcoholic drinks per week, drink at least 4 days a week, and are not seeking treatment for
alcoholism may be eligible for this study. Candidates are screened with a medical history,
including questions about alcohol and drug use, physical examination, blood and urine tests,
breath alcohol test, and electrocardiogram.
Participants are asked about their mental health history and use of alcohol, cigarettes and
illicit drugs, and fill out questionnaires evaluating their emotional state and personality.
Then, they begin a baseline evaluation in which they call a number at the NIH Clinical Center
for 21 days to report how much alcohol they drank that day. One week after starting the
baseline evaluation, they are randomly assigned to take either Rimonabant or placebo (a pill
with no active ingredient) for 2 weeks. Before starting the drug, they have a urine drug
screen and measurement of blood alcohol level. After 1 week on the test medication, they
return to the Clinical Center to monitor drug or placebo side effects, if any, and to have a
blood alcohol level test, urine drug screen, and blood tests for routine blood chemistries.
After 2 weeks on the test medication, they come to the Clinical Center at noon for an alcohol
self-administration test. Before the test, they are given a breath alcohol test and a urine
drug test. The results of both tests must be negative to continue in the study.
The alcohol self-administration test is videotaped. A heparin lock is placed in a vein in the
participant's arm. This small needle remains in the arm for the duration of the study to
avoid multiple needle sticks for blood draws. Blood is drawn periodically during the test to
determine routine laboratory values, cotinine level (assessment of smoking status), the
amount of Rimonabant or placebo in the body, and levels of various hormones. Thirty minutes
before the test begins and every 30 minutes during the test, participants complete
questionnaires and rating scales regarding their mood and desire to drink. Five minutes
before the test be...
Phase:
Phase 2
Details
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)