Overview

Naltrexone Treatment for Alcoholic Women

Status:
Completed
Trial end date:
2000-12-01
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yale University
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Treatments:
Naltrexone
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.