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Naltrexone Treatment of Alcohol Dependence

Primary Purpose

Alcoholism

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
naltrexone (Revia)
Compliance Enhancement Tech.
Cognitive Behavior Therapy
Sponsored by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Treatment Research Center, University of Pennsylvania

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000452
Brief Title
Naltrexone Treatment of Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
November 2004
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Masking
Double
Allocation
Randomized
Enrollment
240 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
naltrexone (Revia)
Intervention Type
Behavioral
Intervention Name(s)
Compliance Enhancement Tech.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Treatment Research Center, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Naltrexone Treatment of Alcohol Dependence

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