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Behavior and Naltrexone Treatment for Alcoholics

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. Identifier: NCT00000449
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : June 24, 2005
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Brief Summary:
The study's purpose is to improve alcoholism treatment by investigating the combined effectiveness of a psychotherapy (Coping Skills Training and Cue Exposure Treatment - CSTCET) with naltrexone in a randomized clinical trial. Individuals will receive 2 weeks of CSTCET or a control treatment as inpatients followed by 12 consecutive weeks of receiving either naltrexone or placebo as outpatients. Followups at 24, 48, and 72 weeks after treatment is completed.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: naltrexone (Revia) Behavioral: cognitive behavioral therapy Behavioral: cue exposure treatment Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
Official Title: Coping, Exposure, and Naltrexone Treatment With Alcoholics
Estimated Study Completion Date : March 2000

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meets criteria for alcohol dependence.

Exclusion Criteria:

  • Current diagnosis of dependence on other substances except nicotine.
  • A history of psychosis or current psychotic symptoms.
  • Current suicidality, homocidality, or psychiatric symptoms that require additional medication.
  • Current use of disulfiram (Antabuse).
  • Evidence of significant cerebral, renal, thyroid, or cardiac disease.
  • History of opioid abuse in the previous year.
  • History of cirrhosis, hepatocellular disease, or elevated bilirubin.
  • Females who are pregnant, nursing, or not using a reliable method of birth control.

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 identifier (NCT number): NCT00000449

United States, Rhode Island
Brown University, Center for Alcohol and Addiction Studies
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA) Identifier: NCT00000449     History of Changes
Other Study ID Numbers: NIAAAMON7850
First Posted: November 3, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: August 2002

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