Status:
COMPLETED
Naltrexone Effects on Alcohol Intake
Lead Sponsor:
University of California, San Francisco
Conditions:
Social Drinker
Eligibility:
All Genders
21+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00254670
Start Date
February 1 2005
End Date
December 1 2006
Last Update
May 8 2023
Active Locations (1)
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1
UCSF
San Francisco, California, United States, 94115