Naltrexone Treatment for Alcoholism

NCT ID: NCT00000438

Last Updated: 2010-05-14

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

192 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2003-03-31

Brief Summary

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This study will evaluate the effectiveness of the medication naltrexone (Revia) for treating alcoholism. Individuals will be inpatients for a 2 week period and provide assessments of their alcohol withdrawal symptoms, craving, and mood. Following hospital discharge, individuals will be assigned randomly to receive naltrexone daily, naltrexone twice a day or a placebo. This part of the study will last 12 weeks, with regular measurements of drinking level, craving and mood. Assessments will be conducted 6 and 12 months after the beginning of the study.

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

Interventions

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naltrexone (Revia)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Meets criteria for alcohol dependence.
* Committed to alcohol abstinence as a treatment goal.
* Individuals will be required to identify two family members or close friends who are knowledgeable about their location, drinking behavior, and psychosocial status.

Exclusion Criteria

* Meets criteria for any other psychoactive substance use disorder (excluding nicotine and caffeine).
* Meets criteria for a major psychiatric disorder and are in need of or currently undergoing pharmacotherapy.
* Females who are pregnant, lactating, or not using a reliable method of contraception.
* Currently experiencing a serious medical condition that would place them at risk or interfere with study participation.
* Experiencing acute hepatitis or liver failure or whose liver function test is more than 3 times normal.
* Have a history of severe allergies, multiple adverse drug reactions or known allergy to naltrexone.
* Vocabulary below the 5th grade reading level.
* Abnormal MRI scan.
* HIV infection due to the neurological sequelae.
* Significant central nervous system diseases.
* Seizure disorder or history of closed head trauma.
* Neuroendocrine disorders.
* Treatment with opiates within the last six months.
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 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

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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R01AA011855

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAAAMCC11855

Identifier Type: -

Identifier Source: org_study_id

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