Naltrexone for Relapse Prevention

This study has been completed.

First Received on November 2, 1999. Last Updated on June 17, 2011 History of Changes

Sponsor:	University of Connecticut Health Center
Collaborator:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	University of Connecticut Health Center
ClinicalTrials.gov Identifier:	NCT00000442

Purpose

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.

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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment
Official Title:	Etiology and Treatment of Alcohol Dependence

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 University of Connecticut Health Center:

Estimated Enrollment:	57
Estimated Study Completion Date:	December 2002

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000442

Locations

United States, Pennsylvania
Department of Psychiatry, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19103

Sponsors and Collaborators

University of Connecticut Health Center

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More Information

No publications provided

Responsible Party:	Henry Kranzler, University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00000442 History of Changes
Other Study ID Numbers:	NIAAAKRA3510, P50AA003510
Study First Received:	November 2, 1999
Last Updated:	June 17, 2011
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists

Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012