Back to resultsBehavior and Naltrexone Treatment for Alcoholics
Primary Purpose
Alcoholism
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
naltrexone (Revia)
cognitive behavioral therapy
cue exposure treatment
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism
Eligibility 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.
Sites / Locations
- Brown University, Center for Alcohol and Addiction Studies
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000449
First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT00000449
Brief Title
Behavior and Naltrexone Treatment for Alcoholics
Official Title
Coping, Exposure, and Naltrexone Treatment With Alcoholics
Study Type
Interventional
2. Study Status
Record Verification Date
August 2002
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Allocation
Randomized
Enrollment
160 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
naltrexone (Revia)
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral therapy
Intervention Type
Behavioral
Intervention Name(s)
cue exposure treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Brown University, Center for Alcohol and Addiction Studies
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Behavior and Naltrexone Treatment for Alcoholics
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