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Naltrexone Effects on Alcohol Intake

Primary Purpose

Social Drinker

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Drinker focused on measuring Alcohol, Naltrexone

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy volunteers who are 21-40 years of age If female, 7-20 alcoholic drinks must be consumed weekly. If male, 10-25 alcoholic drinks must be consumed weekly. If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or double barrier method [male condom, female condom, or diaphragm plus a spermicidal agent such as contraceptive foam, jelly or cream]). Must have a body mass index (BMI) ≥18 and ≤30. Able and willing to provide an informed consent. Able to understand and follow the instructions of the investigator, including the delayed discounting tasks. Have a breath alcohol concentration of less than 0.02 on visits 1, 2, 3, 5, and 6; and 0.00 on visits 4, 4a, 7 and 7a. Exclusion Criteria: Positive urine drug screen Using Cocaine, stimulants (other than nicotine and caffeine), methamphetamine, and/or amphetamines greater than 30 times in the last 24 months Using inhalants, hallucinogens, ecstasy, and/or ketamine greater than 30 times in the last 24 months Current enrollment in an alcohol, or other drug treatment program or current legal problems relating to alcohol, or other drug use, including awaiting trial or supervision by a parole or probation officer Binge drinking more than three times per week (>5 standard drinks in one session is a binge) Currently trying to quit alcohol use Current dependence on any other psychoactive drug (except nicotine or caffeine) and/or alcohol as determined by the study physician's assessment . Clinically significant medical or psychiatric illness as determined by screening blood tests, medical history, and physical exam performed by the study physician

Sites / Locations

  • UCSF

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 15, 2005
Last Updated
May 4, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00254670
Brief Title
Naltrexone Effects on Alcohol Intake
Official Title
Naltrexone Effects on Alcohol Intake Using a Laboratory Bar in Asp40 Positive and Negative Alcohol Users Characterized by fMRI and Genetic Screening
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to examine drinking behavior and decision-making while taking Naltrexone and placebo. This is a double-blind, randomized, placebo-controlled crossover study. There are two cycles: one cycle on Naltrexone and one cycle on placebo.
Detailed Description
The study proposed is a 22 to 23 day, double-blind, placebo-controlled crossover study in 60 male and female moderate to heavy alcohol users who are Asp40 positive and negative. Subjects will undergo a 6 to 7-day cycle taking the first study drug (naltrexone or placebo) with an alcohol self-administration visit in the laboratory bar on the 6th or 7th day of drug. The first alcohol self-administration visit is followed by an 8 to 9 day washout period. Subjects then cross over to repeat the cycle while taking the other drug (placebo or naltrexone). On the final day (either day 8 or 9) of the first study drug cycle, the subject will undergo functional imaging (fMRI) at the WBIC. There will be at least one day in between the 'lab bar' and the fMRI scan. The first fMRI visit is followed by a 5-6 day washout period. Subjects then cross over to repeat the cycle while taking the other drug (placebo or naltrexone). Subjects will keep daily diaries of alcohol and medication use throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Drinker
Keywords
Alcohol, Naltrexone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Naltrexone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers who are 21-40 years of age If female, 7-20 alcoholic drinks must be consumed weekly. If male, 10-25 alcoholic drinks must be consumed weekly. If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or double barrier method [male condom, female condom, or diaphragm plus a spermicidal agent such as contraceptive foam, jelly or cream]). Must have a body mass index (BMI) ≥18 and ≤30. Able and willing to provide an informed consent. Able to understand and follow the instructions of the investigator, including the delayed discounting tasks. Have a breath alcohol concentration of less than 0.02 on visits 1, 2, 3, 5, and 6; and 0.00 on visits 4, 4a, 7 and 7a. Exclusion Criteria: Positive urine drug screen Using Cocaine, stimulants (other than nicotine and caffeine), methamphetamine, and/or amphetamines greater than 30 times in the last 24 months Using inhalants, hallucinogens, ecstasy, and/or ketamine greater than 30 times in the last 24 months Current enrollment in an alcohol, or other drug treatment program or current legal problems relating to alcohol, or other drug use, including awaiting trial or supervision by a parole or probation officer Binge drinking more than three times per week (>5 standard drinks in one session is a binge) Currently trying to quit alcohol use Current dependence on any other psychoactive drug (except nicotine or caffeine) and/or alcohol as determined by the study physician's assessment . Clinically significant medical or psychiatric illness as determined by screening blood tests, medical history, and physical exam performed by the study physician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael C Rowbotham, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

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Naltrexone Effects on Alcohol Intake

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