Naltrexone Treatment for Alcoholic Women - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00000448 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Naltrexone Treatment for Alcoholic Women
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Condition ^ICMJE	Alcoholism Eating Disorder
Intervention ^ICMJE	Drug: naltrexone (Revia)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	120
Completion Date	February 2001
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00000448
Responsible Party
Study ID Numbers ^ICMJE	NIAAAOMA10225
Study Sponsor ^ICMJE	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date	August 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP