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Trial NCT00000440

Resource URI: http://static.linkedct.org/resource/trials/NCT00000440
linkedct:brief_title Sertraline and Naltrexone for Alcohol Dependence
linkedct:condition <http://static.linkedct.org/resource/condition/744>
linkedct:criteria Inclusion Criteria: - Meets the criteria for alcohol dependence. - Abstinent from alcohol for a period of at least 5 days and not greater than 30 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: - Currently meets criteria for substance abuse or dependence with the exception of nicotine dependence. - Current use of disulfiram (Antabuse) or a MAO Inhibitor. - Psychotic or otherwise severely psychiatrically disabled (i.e., depressed, suicidal, current mania). - Major depression at the time of assessment. - Previous treatment with naltrexone (Revia) for alcohol dependence. - Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac disease. - Abstinent longer than 30 days prior to admission to program. - Hepatocellular disease or elevated bilirubin levels. - Females who are pregnant, nursing, or not using a reliable method of birth control.
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 55 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date September 2002
linkedct:enrollment 124 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000440
rdfs:label Trial NCT00000440
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/153733>
linkedct:nct_id NCT00000440
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Sertraline and Naltrexone for Alcohol Dependents
linkedct:org_study_id NIAAAFAR11222
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000440>
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 This study is a double-blind, placebo-controlled outpatient trial to improve, through the addition of sertraline (Zoloft), the abstinence and relapse rates in alcohol- dependent individuals currently taking naltrexone (Revia).
rdf:type linkedct:trials
linkedct:verification_date November 2004