Naltrexone for Relapse Prevention

NCT ID: NCT00000442

Last Updated: 2011-06-20

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

PHASE4

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2002-12-31

Brief Summary

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This study is to evaluate the safety and effectiveness of an injectable slow releasing preparation of naltrexone to reduce alcohol consumption and risk of relapse in alcohol-dependent subjects. Individuals will receive either naltrexone or a placebo injection for a total of three months, with two subsequent followup visits spanning a 6- month period.

Detailed Description

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Conditions

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Alcoholism

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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naltrexone (Revia)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Meets criteria for alcohol dependence.
* Abstinent from alcohol for a period of at least 3 days prior to beginning of study.
* Able to read English and complete study evaluations.
* Females who are postmenopausal, have had surgical sterilization, or use reliable means of birth control.

Exclusion Criteria

* Meets criteria for dependence on a psychoactive substance other than alcohol and nicotine and/or cannabis.
* Prior history of opioid dependence.
* Regular use of psychoactive drugs including anxiolytics and antidepressants.
* Prior treatment with naltrexone.
* Current use of disulfiram.
* Psychotic or otherwise severely psychiatrically disabled (e.g., suicidal, current mania).
* Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac disease.
* Abstinent longer than 28 days prior to randomization.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

UConn Health

OTHER

Sponsor Role lead

Responsible Party

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University of Pennsylvania

Locations

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Department of Psychiatry, University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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P50AA003510

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAAAKRA3510

Identifier Type: -

Identifier Source: org_study_id

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