Naltrexone Treatment of Alcohol Dependence

Alcoholism Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000452
• Other study ID #: NIAAAVOL07517
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: June 23, 2005
• Est. completion date: January 2003

Study information

• Verified date: November 2004
• Source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• naltrexone (Revia)

Behavioral:
• Compliance Enhancement Tech.

• Cognitive Behavior Therapy

Locations

Country	Name	City	State
United States	Treatment Research Center, University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States,