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Trial NCT00000448

Resource URI: http://static.linkedct.org/resource/trials/NCT00000448
linkedct:brief_title Naltrexone Treatment for Alcoholic Women
linkedct:condition <http://static.linkedct.org/resource/condition/4231>
linkedct:condition <http://static.linkedct.org/resource/condition/744>
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 50 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date February 2001
linkedct:enrollment 120 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000448
rdfs:label Trial NCT00000448
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:location <http://static.linkedct.org/resource/location/150189>
linkedct:nct_id NCT00000448
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Naltrexone: Consummatory Behaviors in Alcoholic Women
linkedct:org_study_id NIAAAOMA10225
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000448>
linkedct:phase Phase 4
linkedct:source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:study_design Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date August 2002