Sertraline and Naltrexone for Alcohol Dependents

National Institute on Alcohol Abuse and Alcoholism (NIAAA)1 site in 1 country124 target enrollmentNovember 3, 1999

ConditionsAlcoholism

Drugsnaltrexone (Revia)sertraline (Zoloft)

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Alcoholism
Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Enrollment: 124
Locations: 1
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

November 3, 1999

End Date

September 2002

Last Updated

20 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Eligibility 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.