Protocol Number: 04-AA-0072
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 begins, a blood sample is drawn as a baseline measure to determine the amount of alcohol in the body before beginning the test and to examine the effects of the drug and the alcohol on various hormone levels. At 4 p.m., participants are given an alcoholic drink that they must drink within 5 minutes. They are monitored for the next 50 minutes, during which time they fill out rating scales. At 4:50 p.m., they are presented with four drinks and are given the option to drink as many of the drinks as they like or to receive $3.00 for each drink they do not consume. At 5:50 p.m., the drinks are removed, and at 6:00 p.m. four fresh, new drinks are presented with the same condition - to drink them or receive money for them. The study ends at 7 p.m. Participants are required to stay overnight in the hospital. The next morning, they are given breakfast, their vital signs are checked, they meet with staff to discuss risks associated with heavy alcohol use and are encouraged to participate in an alcohol treatment program. They are given a list of treatment programs and are offered assistance in making arrangements for treatment, if desired. They are then discharged from the hospital at about 9:00 a.m.
National Institutes of Health Clinical Center