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Behavior and Naltrexone Treatment for Alcoholics

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ClinicalTrials.gov Identifier: NCT00000449
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : June 24, 2005
Sponsor:
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)
Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
Official Title: Coping, Exposure, and Naltrexone Treatment With Alcoholics
Study Completion Date : March 2000

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

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 ClinicalTrials.gov identifier (NCT number): NCT00000449


Locations
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)

ClinicalTrials.gov 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:
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