Naltrexone Treatment of Alcohol Dependence

Phase 4

Completed

• Conditions: Alcoholism

• Registration Number: NCT00000452
• Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 1999-11-02
• Study First Submitted QC: 1999-11-02
• Study First Posted: 1999-11-03
• Study Completion: 2003-01
• Status Verified: 2004-11
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Treatment Research Center, University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States