Naltrexone for Relapse Prevention

Phase 4

Completed

• Conditions: Alcoholism

• Registration Number: NCT00000442
• Lead Sponsor: UConn Health

Brief Summary

This study is to evaluate the safety and effectiveness of an injectable slow releasing preparation of naltrexone to reduce alcohol consumption and risk of relapse in alcohol-dependent subjects. Individuals will receive either naltrexone or a placebo injection for a total of three months, with two subsequent followup visits spanning a 6- month period.

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: 2002-12
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-17
• Last Update Posted: 2011-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Meets criteria for alcohol dependence.
• Abstinent from alcohol for a period of at least 3 days prior to beginning of study.
• Able to read English and complete study evaluations.
• Females who are postmenopausal, have had surgical sterilization, or use reliable means of birth control.

Exclusion Criteria

• Meets criteria for dependence on a psychoactive substance other than alcohol and nicotine and/or cannabis.
• Prior history of opioid dependence.
• Regular use of psychoactive drugs including anxiolytics and antidepressants.
• Prior treatment with naltrexone.
• Current use of disulfiram.
• Psychotic or otherwise severely psychiatrically disabled (e.g., suicidal, current mania).
• Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac disease.
• Abstinent longer than 28 days prior to randomization.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Department of Psychiatry, University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States