Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)

Phase 2

Completed

• Conditions: Alcoholism; Alcohol Dependence
• Interventions: Drug: naltrexone; Drug: sertraline

• Registration Number: NCT00000451
• Lead Sponsor: Yale University

Brief Summary

This study will assess the ability of naltrexone (Revia) to reduce the risk of relapse in Alaska natives with alcohol dependence. The study will also examine whether a combination of naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone. Alaska Native individuals will be recruited into a 16 week outpatient study.

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 Start: 2003-01
• Primary Completion: 2005-08
• Study Completion: 2005-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• Alaska Native having biological Alaska Native ancestry.
• Meets criteria for alcohol dependence.
• Prior to entering the study must be abstinent between 3 and 14 days and have a withdrawal assessment.
• Stable residence to ensure that subjects can be located during the study.

Exclusion Criteria

• Currently meets criteria for abuse or dependence on substances other than alcohol or nicotine.
• Current use of disulfiram.
• Psychotic or otherwise severely psychiatrically disabled.
• Use of other psychotropic medications including antidepressants and anxiolytics.
• Medical conditions that would not permit the use of sertraline or naltrexone, such as a history of unstable or severe hepatic, cardiovascular, metabolic, endocrine, gastrointestinal or kidney disease.
• Hepatocellular disease or elevated bilirubin levels.
• Females who are pregnant, nursing, or not using a reliable method of birth control.
• Probation or parole requirements that might interfere with participation in the study.
• Involvement in alcohol treatment other than provided by the study or AA.
• Use of monoamine oxidase inhibitors in the past month.
• Current use of Type 1C antiarrhythmics propafenone and flecainide.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	naltrexone	Naltrexone plus Sertraline
2	sertraline	Naltrexone alone
2	naltrexone	Naltrexone alone

Primary Outcome Measures

Name	Time	Method
Days abstinent