Status:
COMPLETED
Naltrexone Treatment of Alcohol Dependence
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholism
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 th...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
January 1 2003
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00000452
End Date
January 1 2003
Last Update
June 24 2005
Active Locations (1)
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1
Treatment Research Center, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104