Naltrexone Treatment for Alcoholic Women

Alcoholism Clinical Trial

Official title:

Naltrexone: Consummatory Behaviors in Alcoholic Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000448
• Other study ID #: NIAAAOMA10225
• Secondary ID: R01AA010225
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: May 6, 2014
• Start date: October 1995
• Est. completion date: December 2000

Study information

• Verified date: May 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2000
• Est. primary completion date: December 2000
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism
• Eating Disorder
• Eating Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Substance Abuse Treatment Unit, Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

O'Malley SS, Sinha R, Grilo CM, Capone C, Farren CK, McKee SA, Rounsaville BJ, Wu R. Naltrexone and cognitive behavioral coping skills therapy for the treatment of alcohol drinking and eating disorder features in alcohol-dependent women: a randomized cont — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first day of drinking		12 week treatment period	No
Primary	Time to first day of heavy drinking	Defined as consuming 4 or more drinks during the 12-week period	12 weeks	No
Secondary	Percentage of days abstinent		12 weeks of treatment	No
Secondary	Percentage of heavy drinking days		12 weeks of treatment	No
Secondary	Beck Depression Index	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.	12 weeks of treatment	No
Secondary	Obsessive Compulsive Drinking Scale (OCDS)	The OCDS was developed to reflect obsessionality and compulsivity related to craving and drinking behavior.	Baseline, Month 1, 2, 3	No
Secondary	Eating Disorder Examination (EDE)	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.	baseline, month 1, 2, 3	No

External Links

•   Published paper