Naltrexone Treatment for Alcoholic Women

Completed · Phase 4 · Has a placebo group

Conditions studied: Alcoholism, Eating Disorder

In brief

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.

Key facts

Study ID

NCT00000448

Run by

Yale University

People needed

160

Starts

1995-10-01

Expected to finish

2000-12-01

Last updated by the study team

2014-05-07

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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