Naltrexone Treatment of Alcohol Dependence

National Institute on Alcohol Abuse and Alcoholism (NIAAA)1 site in 1 country240 target enrollmentNovember 3, 1999

ConditionsAlcoholism

Drugsnaltrexone (Revia)

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Alcoholism
Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Enrollment: 240
Locations: 1
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 3, 1999

End Date

January 2003

Last Updated

20 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Eligibility 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.