Naltrexone Treatment of Alcohol Dependence

• Status: Completed
• Trial end date: 2003-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The long-range goal of this ongoing research program is to find more effective treatments for alcohol dependence by combining medication with the appropriate psychosocial support. This proposal has three specific aims: (1) to compare the effectiveness of naltrexone (Revia) in three types of treatment settings; (2) to assess the effects of psychosocial support on medication compliance and treatment retention; and (3) to investigate the individual characteristics that may predict who is likely to benefit from additional psychosocial support versus simple medication management.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Naltrexone

Criteria

Inclusion Criteria:

• Meets criteria for current diagnosis of alcohol dependence.

• Subjects used more than 15 standard alcohol drinks (average)/week with at least 1 day of 5 or more drinks in the past 30 days.

• Successful completion of medical detoxification.

• Lives within a commutable distance to the Treatment Research Center and agrees to follow-up visits.

• Understands and signs the informed consent.

Exclusion Criteria:

• Current diagnosis of any substance dependence other than alcohol, nicotine, or marijuana.

• Evidence of opiate use in the past 30 days.

• Current treatment with psychotropic medications, including disulfiram (Antabuse) (excluding short-term use of benzodiazepines for detoxification).

• History of unstable or serious medical illness, including need for opioid analgesics.

• Severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated bilirubin levels, and current severe psychiatric symptoms.

• Use of an investigation medication in the past 30 days.

• Female subjects who are pregnant, nursing, or not using reliable method of contraception.