Use of Naltrexone in a Clinical Setting

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.

Completed

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

naltrexone (Revia)

Drug

Sponsors and collaborators

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Nih

Registry information

Official study title

Effectiveness of Naltrexone in a Community Setting

Important dates

Study completion: 2002
First posted: Nov 3, 1999
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed