Social Drinker Clinical Trial
Official title:
Naltrexone Effects on Alcohol Intake Using a Laboratory Bar in Asp40 Positive and Negative Alcohol Users Characterized by fMRI and Genetic Screening
Verified date | March 2011 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | December 2006 |
Est. primary completion date | December 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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United States | UCSF | San Francisco | California |
Lead Sponsor | Collaborator |
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University of California, San Francisco |
United States,