Use of Naltrexone in a Clinical Setting

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

300 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2002-09-30

Brief Summary

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This 12-week trial will compare individuals receiving naltrexone or placebo plus substance abuse counseling therapy versus those receiving only substance abuse counseling therapy in a rural, nonacademic setting. A followup period of 12 months is included. The effect on service utilization and the cost of the addition of naltrexone to treatment services for alcohol dependence also will be assessed. The study will expand existing research concerning the effectiveness of naltrexone in clinical trials versus a clinical setting.

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

NONE

Interventions

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naltrexone (Revia)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Meets criteria for alcohol dependence (within the past 3 months).
* Meets criteria for another substance use disorder (except narcotic dependence) but must identify alcohol as the primary substance of abuse.
* Must be able to provide an informed consent.
* Consent to random assignment and be willing to commit to possible medication treatment and research follow-up.
* Must be eligible for treatment at the Dorchester Alcohol and Drug Commission.

Exclusion Criteria

* Meets criteria for opiate dependence.
* Clinically significant medical problems such as collagen-vascular disease, cardiovascular, renal, gastrointestinal or endocrine problem that would impair participation or limit medication ingestion.
* Hepatocellular disease.
* Women who are pregnant, nursing, or not practicing an effective means of birth control.
* Currently being prescribed naltrexone.
* Known sensitivity or allergy to naltrexone.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Center for Drug and Alcohol Programs, Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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NIAAABRA11747

Identifier Type: -

Identifier Source: org_study_id