Naltrexone Treatment for Alcoholic Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Naltrexone: Consummatory Behaviors in Alcoholic Women

Conditions
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Alcoholism, Eating Disorder

Intervention / Treatment
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* Drug: naltrexone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Subjects were given an inert placebo for 2 days, followed by daily doses of matching placebo for a total of 12 weeks. | Drug: Placebo<br>* A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient.<br>|
| Experimental: Naltrexone<br>Subjects were prescribed 25 mg naltrexone for 2 days, followed by daily doses of 50 mg of naltrexone for a total of 12 weeks. | Drug: naltrexone<br>* Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence.<br>* Other names: Depade;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first day of drinking |  | 12 week treatment period | 
| Time to first day of heavy drinking | Defined as consuming 4 or more drinks during the 12-week period | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of days abstinent |  | 12 weeks of treatment | 
| Percentage of heavy drinking days |  | 12 weeks of treatment | 
| 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 | 
| 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 | 
| 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 |