Naltrexone Treatment for Alcoholic Women

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:	NCT00000448

Purpose

This study will assess naltrexone's effectiveness in treating alcoholism in women and provide information on its potential value in treating eating disorders common among alcoholic women. Alcoholic women with and without both eating disorders and depression will be randomly assigned to placebo or naltrexone treatment. Each group will receive behavioral therapy for 12 weeks, with followup 6 months after treatment.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Official Title:	Naltrexone: Consummatory Behaviors in Alcoholic Women

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Eating Disorders

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:	120
Estimated Study Completion Date:	February 2001

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meets criteria for alcohol dependence. Abstinent from alcohol for a period of at least 5 days.
Able to read English and complete study evaluations.
A stable residence and a telephone to ensure that subjects can be located during the study.

Exclusion Criteria:

Meets criteria for dependence on another psychoactive substance besides alcohol or nicotine.
Regular use of psychoactive drugs except antidepressants.
Current use of disulfiram (Antabuse).
Psychotic or otherwise severely psychiatrically disabled.
Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac pathology.
Abstinent longer than 30 days prior to admission to program.
Hepatocellular disease or elevated bilirubin levels.
Individuals with present history of opiate abuse or who require the use of opioid analgesics.
Women who are pregnant, nursing, or not using a reliable method of birth control.
Women who are significantly overweight or significantly underweight.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000448

Locations

United States, Connecticut
Substance Abuse Treatment Unit, Yale University
New Haven, Connecticut, United States, 06511

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More Information

No publications provided

Study ID Numbers:	NIAAAOMA10225
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000448 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
Eating Disorders

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
Eating Disorders

ClinicalTrials.gov processed this record on July 02, 2009