Sertraline and Naltrexone for Alcohol Dependence

Phase 2

Completed

• Conditions: Alcoholism

• Registration Number: NCT00000440
• Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Brief Summary

This study is a double-blind, placebo-controlled outpatient trial to improve, through the addition of sertraline (Zoloft), the abstinence and relapse rates in alcohol- dependent individuals currently taking naltrexone (Revia).

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: 2002-09
• Status Verified: 2004-11
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Meets the criteria for alcohol dependence.
• Abstinent from alcohol for a period of at least 5 days and not greater than 30 days.
• Able to read English and complete study evaluations.
• A stable residence and a telephone to ensure that subjects can be located during the study.

Exclusion Criteria

• Currently meets criteria for substance abuse or dependence with the exception of nicotine dependence.
• Current use of disulfiram (Antabuse) or a MAO Inhibitor.
• Psychotic or otherwise severely psychiatrically disabled (i.e., depressed, suicidal, current mania).
• Major depression at the time of assessment.
• Previous treatment with naltrexone (Revia) for alcohol dependence.
• Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac disease.
• Abstinent longer than 30 days prior to admission to program.
• Hepatocellular disease or elevated bilirubin levels.
• Females who are pregnant, nursing, or not using a reliable method of birth control.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Department of Psychiatry, Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States