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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000452
Other study ID # NIAAAVOL07517
Secondary ID
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
Est. primary completion date
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


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, 

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