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Naltrexone Treatment of Alcohol Dependence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000452
First Posted: November 3, 1999
Last Update Posted: June 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  Purpose
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.

Condition Intervention Phase
Alcoholism Drug: naltrexone (Revia) Behavioral: Compliance Enhancement Tech. Behavioral: Cognitive Behavior Therapy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Estimated Enrollment: 240
Estimated Study Completion Date: January 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000452


Locations
United States, Pennsylvania
Treatment Research Center, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  More Information

ClinicalTrials.gov Identifier: NCT00000452     History of Changes
Other Study ID Numbers: NIAAAVOL07517
First Submitted: November 2, 1999
First Posted: November 3, 1999
Last Update Posted: June 24, 2005
Last Verified: November 2004

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents