Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075205
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-01-05
Brief Title:
Rimonabant to Reduce Alcohol Consumption
Sponsor:
National Institute on Alcohol Abuse and Alcoholism NIAAA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Clinical Trial of the Cannabinoid CB1 Receptor Antagonist SR141716 Rimonabant to Reduce Voluntary Ethanol Drinking in Healthy Non-Treatment Seeking Individuals Who Consume Between 20 and 50 Drinks Per Week
Status:
COMPLETED
Status Verified Date:
2010-06-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 participants 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
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 participants 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
Detailed Description:
Recent studies show that endogenous cannabinoids modulate appetitive behaviors For example an antagonist of the CB1 cannabinoid receptor SR141716 decreases food intake in animals as well as in humans and decreases alcohol consumption in rodent models of voluntary ethanol consumption In this protocol individuals consuming between 20 and 40 alcohol drinks per week and who are not seeking alcohol treatment will be recruited from the community Following a one week baseline evaluation participants will be randomized according to a double-blind design to receive either placebo or SR141716 for two additional weeks prior to being admitted to the hospital to participate in an alcohol self-administration experiment The design of this experiment has been previously shown by OMalley et al 1 to be an effective paradigm to study the effects of medication on alcohol consumption Following baseline psychological and endocrine measures participants will receive a priming dose of ethanol designed to raise the breath alcohol levels BAL to 003 gdl and then have the opportunity to consume up to eight drinks or to receive 3 dollars for each drink not consumed over a two hour period It is hypothesized that participants receiving SR141716 compared to those receiving placebo will have decreased alcohol consumption Following the study each participant will be carefully counseled about their alcohol consumption and provided referrals for alcohol treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-AA-0072 | None | None | None |