Naltrexone Effects on Alcohol Intake

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Ethanol; Naltrexone

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