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