Sertraline and Naltrexone for Alcohol Dependence

Alcoholism Clinical Trial

Official title:

Sertraline and Naltrexone for Alcohol Dependents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000440
• Other study ID #: NIAAAFAR11222
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005
• Est. completion date: September 2002

Study information

• Verified date: November 2004
• Source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• naltrexone (Revia)

• sertraline (Zoloft)

Locations

Country	Name	City	State
United States	Department of Psychiatry, Mount Sinai School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States,