Naltrexone Treatment of Alcohol Dependence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2003-01-31

Brief Summary

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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

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Conditions

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Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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naltrexone (Revia)

Intervention Type DRUG

Compliance Enhancement Tech.

Intervention Type BEHAVIORAL

Cognitive Behavior Therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Treatment Research Center, University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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NIAAAVOL07517

Identifier Type: -

Identifier Source: org_study_id