Naltrexone Treatment for Alcoholic Women - Tabular View

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Naltrexone Treatment for Alcoholic Women

This study has been completed.

Study NCT00000448. Last updated on June 23, 2005. Information provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Naltrexone Treatment for Alcoholic Women
Official Title ^†	Naltrexone: Consummatory Behaviors in Alcoholic Women
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 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
Study Phase	Phase IV
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Alcoholism Eating Disorder
Intervention ^†	Drug: naltrexone (Revia)
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	120
Start Date ^†
Completion Date	February 2001
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.
Gender	Female
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00000448
Organization ID	NIAAAOMA10225
Secondary IDs ^††
Study Sponsor ^†	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators ^††
Investigators ^†
Information Provided By	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date	August 2002
First Received Date ^†	November 2, 1999
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.