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Behavior and Naltrexone Treatment for Alcoholics

Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
Overall Status
Completed
CT.gov ID
NCT00000449
Collaborator
(none)
160
Enrollment
1
Location

Study Details

Study Description

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
  • Drug: naltrexone (Revia)
  • Behavioral: cognitive behavioral therapy
  • Behavioral: cue exposure treatment
 Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Primary Purpose:
Treatment
Official Title:
Coping, Exposure, and Naltrexone Treatment With Alcoholics
Study Completion Date :
Mar 1, 2000

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00000449
    Other Study ID Numbers:
    • NIAAAMON7850
    First Posted:
    Nov 3, 1999
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Aug 1, 2002
    Additional relevant MeSH terms:
    Alcoholism
    Naltrexone

    Study Results

    No Results Posted as of Jun 24, 2005