Sertraline and Naltrexone for Alcohol Dependence

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Alcoholism

Treatments: Drug: naltrexone (Revia); Drug: sertraline (Zoloft)

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000440

NIAAAFAR11222

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.