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Trial NCT00000451

Resource URI: http://static.linkedct.org/resource/trials/NCT00000451
PropertyValue
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/18868>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/6958>
linkedct:brief_title Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)
linkedct:condition <http://static.linkedct.org/resource/condition/714>
linkedct:condition <http://static.linkedct.org/resource/condition/744>
linkedct:criteria Inclusion Criteria: - Alaska Native having biological Alaska Native ancestry. - Meets criteria for alcohol dependence. - Prior to entering the study must be abstinent between 3 and 14 days and have a withdrawal assessment. - Stable residence to ensure that subjects can be located during the study. Exclusion Criteria: - Currently meets criteria for abuse or dependence on substances other than alcohol or nicotine. - Current use of disulfiram. - Psychotic or otherwise severely psychiatrically disabled. - Use of other psychotropic medications including antidepressants and anxiolytics. - Medical conditions that would not permit the use of sertraline or naltrexone, such as a history of unstable or severe hepatic, cardiovascular, metabolic, endocrine, gastrointestinal or kidney disease. - Hepatocellular disease or elevated bilirubin levels. - Females who are pregnant, nursing, or not using a reliable method of birth control. - Probation or parole requirements that might interfere with participation in the study. - Involvement in alcohol treatment other than provided by the study or AA. - Use of monoamine oxidase inhibitors in the past month. - Current use of Type 1C antiarrhythmics propafenone and flecainide.
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 65 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date November 2007
linkedct:enrollment 198 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000451
linkedct:intervention <http://static.linkedct.org/resource/intervention/24433>
linkedct:intervention <http://static.linkedct.org/resource/intervention/24434>
rdfs:label Trial NCT00000451
linkedct:lastchanged_date May 6, 2008
linkedct:lead_sponsor_agency National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:location <http://static.linkedct.org/resource/location/135715>
linkedct:nct_id NCT00000451
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives
linkedct:org_study_id NIAAAOMA12028
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/15022>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000451>
linkedct:phase Phase 2
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/6231>
linkedct:source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:start_date January 2003
linkedct:study_design Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary This study will assess the ability of naltrexone (Revia) to reduce the risk of relapse in Alaska natives with alcohol dependence. The study will also examine whether a combination of naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone. Alaska Native individuals will be recruited into a 16 week outpatient study.
rdf:type linkedct:trials
linkedct:verification_date May 2008