Sertraline and Naltrexone for Alcohol Dependence

• Status: Completed
• Trial end date: 2002-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Naltrexone; Sertraline

Criteria

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.