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Naltrexone Treatment for Alcoholic Women - Article


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Clinical Trial: Naltrexone Treatment for Alcoholic Women

This study has been completed.

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Purpose

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.

Condition Treatment or Intervention Phase
Alcoholism
Eating Disorder
 Drug: naltrexone (Revia)
Phase IV

MedlinePlus related topics:  Alcoholism;   Eating Disorders

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Official Title: Naltrexone: Consummatory Behaviors in Alcoholic Women

Further Study Details: 

Expected Total Enrollment:  120

Study completion: February 2001

Eligibility

Ages Eligible for Study:  18 Years   -   50 Years,  Genders Eligible for Study:  Female

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.

Location Information


Connecticut
      Substance Abuse Treatment Unit, Yale University, New Haven,  Connecticut,  06511,  United States

More Information

Study ID Numbers:  NIAAAOMA10225
Record last reviewed:  August 2002
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000448
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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