NCT00000448

Naltrexone Treatment for Alcoholic Women

Naltrexone: Consummatory Behaviors in Alcoholic Women

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Alcoholism
• Eating Disorder

Interventions

Type	Name	Description
DRUG	naltrexone	Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence.
DRUG	Placebo	A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient.

Timeline

• Start date: 1995-10-01
• Primary completion: 2000-12-01
• Completion: 2000-12-01
• First posted: 1999-11-03
• Last updated: 2014-05-07

Locations

1 site across 1 country: United States