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Completed

NCT Number: NCT00000448

Naltrexone Treatment for Alcoholic Women

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.

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Eating Disorder Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Substance Abuse Treatment Unit, Yale University

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naltrexone

Drug

Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence.

Other names: Revia, Depade

Placebo

Drug

A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient.

Primary outcomes

  1. Time to first day of drinking

    Time frame: 12 week treatment period

  2. Time to first day of heavy drinking

    Time frame: 12 weeks

    Defined as consuming 4 or more drinks during the 12-week period

Secondary outcomes

  1. Percentage of days abstinent

    Time frame: 12 weeks of treatment

  2. Percentage of heavy drinking days

    Time frame: 12 weeks of treatment

  3. Beck Depression Index

    Time frame: 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.

  4. Obsessive Compulsive Drinking Scale (OCDS)

    Time frame: Baseline, Month 1, 2, 3

    The OCDS was developed to reflect obsessionality and compulsivity related to craving and drinking behavior.

  5. Eating Disorder Examination (EDE)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Naltrexone: Consummatory Behaviors in Alcoholic Women

Important dates

Study start
1995
Primary completion
2000
Study completion
2000
First posted
Nov 3, 1999
Registry last updated
May 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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