Sertraline and Naltrexone for Alcohol Dependence

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

124 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2002-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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naltrexone (Revia)

Intervention Type DRUG

sertraline (Zoloft)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Department of Psychiatry, Mount Sinai School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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NIAAAFAR11222

Identifier Type: -

Identifier Source: org_study_id