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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Alcoholism Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Naltrexone plus Sertraline

Group Type EXPERIMENTAL

naltrexone

Intervention Type DRUG

16 week outpatient study

2

Naltrexone alone

Group Type EXPERIMENTAL

sertraline

Intervention Type DRUG

16 week outpatient study

naltrexone

Intervention Type DRUG

16 week outpatient study

Interventions

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sertraline

16 week outpatient study

Intervention Type DRUG

naltrexone

16 week outpatient study

Intervention Type DRUG

Other Intervention Names

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Zoloft Revia

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No