Rimonabant to Reduce Alcohol Consumption

Completed · Phase 2

Conditions studied: Healthy, Alcohol Drinking

In brief

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...

Key facts

Study ID

NCT00075205

Run by

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

People needed

54

Starts

2003-12-31

Expected to finish

2007-03-15

Last updated by the study team

2017-07-02

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Any history or presence of significant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic (including any history of convulsions), systemic, infectious diseases, or psychiatric disorders (i.e., a current diagnosis of major depression, panic disorder, eating disorders, or history of schizophrenia, bipolar disorder, or obsessive compulsive disorder). Individuals who report suicidal ideation or who have a past history of suicide attempts.
• Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
• Symptomatic hypotension whenever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in systolic blood pressure (SBP) equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position.
• Blood donation within three months before administration.
• Presence or history of any allergy or unusual reactions to drugs or anesthetics that would suggest the participant could have a problem tolerating SR141716 or placebo.
• A participant who, in the judgment of the Investigator, is likely to be non-compliant, is violent when drinking, or is unable to cooperate because of a language problem or poor mental development.
• Participant who cannot be contacted in case of emergency.
• Currently taking any prescription medications or over-the-counter medications on a regular basis. Participants will be allowed to take an occasional pain medication or an antibiotic, if they get sick during their participation in the protocol.
• Excessive consumption of beverages with xanthine bases (greater than 6 cups or glasses/day).
• Female participants who have a positive Beta-HCG test (urine and/or plasma) or who are lactating.
• Positive reaction to any of the following tests: HBs antigen, anti-HCVantibody, anti-HIV1 antibodies, anti-HIV2 antibodies. (Hepatitis could interfere with the metabolism of SR141716 in the liver. HIV could alter brain function.)
• Positive results of screening for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates).
• A DSM-IV diagnosis of illicit drug dependence in the last 6 months.
• Participants who come to the NIAAA Clinic and evidence withdrawal symptoms that result in a score of 8 or above on the CIWA Instrument.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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