Use of Naltrexone in a Clinical Setting

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsored by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00000445

Purpose

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.

Condition	Intervention	Phase
Alcoholism	Drug: naltrexone (Revia)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Efficacy Study
Official Title:	Effectiveness of Naltrexone in a Community Setting

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Estimated Enrollment:	300
Estimated Study Completion Date:	September 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000445

Locations

United States, South Carolina
Center for Drug and Alcohol Programs, Medical University of South Carolina
Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More Information

No publications provided

Study ID Numbers:	NIAAABRA11747
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000445 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Mental Disorders
Narcotic Antagonists
Naltrexone
Alcoholism
Substance-Related Disorders

Disorders of Environmental Origin
Narcotics
Alcohol-Related Disorders
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Narcotic Antagonists
Physiological Effects of Drugs
Disorders of Environmental Origin
Pharmacologic Actions
Mental Disorders
Sensory System Agents
Therapeutic Uses

Alcoholism
Naltrexone
Substance-Related Disorders
Alcohol-Related Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009