Status:
COMPLETED
Naltrexone Treatment for Alcoholic Women
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholism
Eating Disorder
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief 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 wo...
Detailed 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 naltr...
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.
Key Trial Info
Start Date :
October 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2000
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00000448
Start Date
October 1 1995
End Date
December 1 2000
Last Update
May 7 2014
Active Locations (1)
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1
Substance Abuse Treatment Unit, Yale University
New Haven, Connecticut, United States, 06511