Naltrexone Treatment for Alcoholic Women

Phase 4

Completed

• Conditions: Alcoholism; Eating Disorder
• Interventions: Drug: Placebo; Drug: naltrexone

• Registration Number: NCT00000448
• Lead Sponsor: Yale University

Brief 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.

Study Timeline

• Study Start: 1995-10
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 1999-11-02
• Study First Posted: 1999-11-03
• Primary Completion: 2000-12
• Study Completion: 2000-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-06
• Last Update Posted: 2014-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects were given an inert placebo for 2 days, followed by daily doses of matching placebo for a total of 12 weeks.
Naltrexone	naltrexone	Subjects were prescribed 25 mg naltrexone for 2 days, followed by daily doses of 50 mg of naltrexone for a total of 12 weeks.

Primary Outcome Measures

Name	Time	Method
Time to first day of heavy drinking	12 weeks	Defined as consuming 4 or more drinks during the 12-week period
Time to first day of drinking	12 week treatment period

Secondary Outcome Measures

Name	Time	Method
Percentage of days abstinent	12 weeks of treatment
Percentage of heavy drinking days	12 weeks of treatment
Beck Depression Index	12 weeks of treatment	The Beck Depression Inventory (BDI, BDI-1A, BDI-II), created by Dr. Aaron T. Beck, is a 21-question multiple-choice self-report inventory. Higher total scores indicate more severe depressive symptoms. This was administered bi-weekly throughout the treatment period.
Obsessive Compulsive Drinking Scale (OCDS)	Baseline, Month 1, 2, 3	The OCDS was developed to reflect obsessionality and compulsivity related to craving and drinking behavior.
Eating Disorder Examination (EDE)	baseline, month 1, 2, 3	The Eating Disorder Examination Interview (EDE) devised by Cooper \& Fairburn (1987) is a semi-structured interview conducted by a clinician in the assessment of an eating disorder. The questions concern the frequency in which the patient engages in behaviors indicative of an eating disorder over a 28 day period. The test is scored on a 7 point scale from 0-6. With a zero score indicating not having engaged in the questioned behavior.

Trial Locations

Locations (1)

Substance Abuse Treatment Unit, Yale University; 🇺🇸 New Haven, Connecticut, United States