Expired Study
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New Haven, Connecticut 06511


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.


Study summary:

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.


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.


NCT ID:

NCT00000448


Primary Contact:

Principal Investigator
Stephanie S O'Malley, PhD
Yale School of Medicine


Backup Contact:

N/A


Location Contact:

New Haven, Connecticut 06511
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: July 23, 2017

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