Search / Trial NCT00000448

Naltrexone Treatment for Alcoholic Women

Launched by YALE UNIVERSITY · Nov 2, 1999

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Trial Information

Current as of September 11, 2024

Completed

Keywords

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 random...

Gender

FEMALE

Eligibility criteria

  • 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.

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

New Haven, Connecticut, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0