Naltrexone Treatment of Alcohol Dependence

This study has been completed.

Sponsored by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00000452

Purpose

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.

Condition	Intervention	Phase
Alcoholism	Drug: naltrexone (Revia) Behavioral: Compliance Enhancement Tech. Behavioral: Cognitive Behavior Therapy	Phase IV

MedlinePlus related topics: Alcoholism

Drug Information available for: Naltrexone Naltrexone hydrochloride Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Estimated Enrollment:	240
Estimated Study Completion Date:	January 2003

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000452

Locations

United States, Pennsylvania
Treatment Research Center, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More Information

Study ID Numbers:	NIAAAVOL07517
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000452
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Mental Disorders
Naltrexone
Alcoholism
Substance-Related Disorders

Disorders of Environmental Origin
Alcohol-Related Disorders
Ethanol

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Narcotic Antagonists

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 10, 2009