Naltrexone Treatment for Alcoholic Women

Yale University

Status and phase

Completed

Phase 4

Conditions

Alcoholism

Eating Disorder

Treatments

Drug: Placebo

Drug: naltrexone

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00000448

R01AA010225 (U.S. NIH Grant/Contract)

NIAAAOMA10225

Details and patient eligibility

About

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.

Full description

Background: Despite important gender differences in drinking patterns, physiological effects of alcohol, and co-occurring psychiatric conditions, relatively little is known about the efficacy of naltrexone for the treatment of alcohol dependence in women. This study investigated the safety and efficacy of naltrexone in combination with Cognitive Behavioral Coping Skills Therapy (CBCST) in a sample of alcohol-dependent women, some with comorbid eating pathology.

Methods: One hundred three women meeting DSM-IV criteria for alcohol dependence (29 with comorbid eating disturbances) were randomized to receive either naltrexone or placebo for 12 weeks in addition to weekly group CBCST.

Enrollment

160 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.