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Trial NCT00000443

Resource URI: http://static.linkedct.org/resource/trials/NCT00000443
linkedct:brief_title Ondansetron Treatment for Alcoholism
linkedct:condition <http://static.linkedct.org/resource/condition/744>
linkedct:criteria Inclusion Criteria: - Meet criteria for alcohol dependence. - Subjects with early onset alcoholism must also have a diagnosis of antisocial personality disorder. - Understand the requirements of the study and be able to complete the questionnaires and rating scales. Exclusion Criteria: - Current diagnosis of substance dependence or self-report of having used narcotics (opiates, cocaine, amphetamine-like substances, and hallucinogens) in the 30 day period prior to study. - Positive urine drug screen test for narcotics, barbiturates, or benzodiazepines. - Receiving current psychotropic medications. - Current history of other psychiatric disorders excluding nicotine dependence. - Hepatocellular disease. - Pregnant females.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 60 Years
linkedct:eligibility_minimum_age 25 Years
linkedct:end_date April 2000
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000443
rdfs:label Trial NCT00000443
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/202096>
linkedct:nct_id NCT00000443
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Pharmacological Treatment for Alcoholism
linkedct:org_study_id NIAAAJOH10522
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000443>
linkedct:phase Phase 2
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 The purpose of this study is to: a) evaluate the effectiveness of ondansetron (Zofran) in the treatment of alcohol dependent patients; b) investigate whether early versus late onset alcoholism predicts treatment outcome; and c) determine whether the early and late onset groups respond differently to treatment. Individuals will be "typed" into early onset and late onset alcoholism groups. Individuals will be randomly assigned to a 12-week outpatient treatment program.
rdf:type linkedct:trials
linkedct:verification_date August 2002