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Completed

NCT Number: NCT00000452

Naltrexone Treatment of Alcohol Dependence

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.

Completed

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Treatment Research Center, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

naltrexone (Revia)

Drug

Compliance Enhancement Tech.

Behavioral

Cognitive Behavior Therapy

Behavioral

Sponsors and collaborators

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Nih

Registry information

Important dates

Study completion
2003
First posted
Nov 3, 1999
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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