Behavior and Naltrexone Treatment for Alcoholics

Phase 4

Completed

• Conditions: Alcoholism

• Registration Number: NCT00000449
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 1999-11-02
• Study First Submitted QC: 1999-11-02
• Study First Posted: 1999-11-03
• Study Completion: 2000-03
• Status Verified: 2002-08
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Trial Locations

Locations (1)

Brown University, Center for Alcohol and Addiction Studies; 🇺🇸 Providence, Rhode Island, United States