Nctid:
NCT00000451
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000437", "term"=>"Alcoholism"}], "ancestors"=>[{"id"=>"D000019973", "term"=>"Alcohol-Related Disorders"}, {"id"=>"D000019966", "term"=>"Substance-Related Disorders"}, {"id"=>"D000064419", "term"=>"Chemically-Induced Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M3783", "name"=>"Alcoholism", "asFound"=>"Alcohol Dependence", "relevance"=>"HIGH"}, {"id"=>"M21842", "name"=>"Alcohol-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M21837", "name"=>"Substance-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M30302", "name"=>"Chemically-Induced Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Substance Related Disorders", "abbrev"=>"BC25"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000009271", "term"=>"Naltrexone"}, {"id"=>"D000020280", "term"=>"Sertraline"}], "ancestors"=>[{"id"=>"D000000427", "term"=>"Alcohol Deterrents"}, {"id"=>"D000009292", "term"=>"Narcotic Antagonists"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000000928", "term"=>"Antidepressive Agents"}, {"id"=>"D000011619", "term"=>"Psychotropic Drugs"}, {"id"=>"D000017367", "term"=>"Selective Serotonin Reuptake Inhibitors"}, {"id"=>"D000014179", "term"=>"Neurotransmitter Uptake Inhibitors"}, {"id"=>"D000049990", "term"=>"Membrane Transport Modulators"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D000018490", "term"=>"Serotonin Agents"}], "browseLeaves"=>[{"id"=>"M3777", "name"=>"Ethanol", "relevance"=>"LOW"}, {"id"=>"M12222", "name"=>"Naltrexone", "asFound"=>"Lumbar", "relevance"=>"HIGH"}, {"id"=>"M22100", "name"=>"Sertraline", "asFound"=>"Occur", "relevance"=>"HIGH"}, {"id"=>"M12245", "name"=>"Narcotics", "relevance"=>"LOW"}, {"id"=>"M12243", "name"=>"Narcotic Antagonists", "relevance"=>"LOW"}, {"id"=>"M4247", "name"=>"Antidepressive Agents", "relevance"=>"LOW"}, {"id"=>"M14474", "name"=>"Psychotropic Drugs", "relevance"=>"LOW"}, {"id"=>"M15512", "name"=>"Serotonin", "relevance"=>"LOW"}, {"id"=>"M19649", "name"=>"Selective Serotonin Reuptake Inhibitors", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Alcohol Deterrents", "abbrev"=>"AlcDet"}, {"name"=>"Narcotic Antagonists", "abbrev"=>"NarcAntag"}, {"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>198}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2003-01"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2013-01", "completionDateStruct"=>{"date"=>"2005-11", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2013-01-28", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"1999-11-02", "lastUpdatePostDateStruct"=>{"date"=>"2013-01-29", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-03", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2005-08", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Days abstinent"}]}, "conditionsModule"=>{"keywords"=>["Alcoholism", "Alcohol Dependence"], "conditions"=>["Alcoholism", "Alcohol Dependence"]}, "descriptionModule"=>{"briefSummary"=>"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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Alaska Native having biological Alaska Native ancestry.\n* Meets criteria for alcohol dependence.\n* Prior to entering the study must be abstinent between 3 and 14 days and have a withdrawal assessment.\n* Stable residence to ensure that subjects can be located during the study.\n\nExclusion Criteria:\n\n* Currently meets criteria for abuse or dependence on substances other than alcohol or nicotine.\n* Current use of disulfiram.\n* Psychotic or otherwise severely psychiatrically disabled.\n* Use of other psychotropic medications including antidepressants and anxiolytics.\n* 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.\n* Hepatocellular disease or elevated bilirubin levels.\n* Females who are pregnant, nursing, or not using a reliable method of birth control.\n* Probation or parole requirements that might interfere with participation in the study.\n* Involvement in alcohol treatment other than provided by the study or AA.\n* Use of monoamine oxidase inhibitors in the past month.\n* Current use of Type 1C antiarrhythmics propafenone and flecainide."}, "identificationModule"=>{"nctId"=>"NCT00000451", "briefTitle"=>"Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)", "organization"=>{"class"=>"OTHER", "fullName"=>"Yale University"}, "officialTitle"=>"Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives", "orgStudyIdInfo"=>{"id"=>"NIAAAOMA12028"}, "secondaryIdInfos"=>[{"id"=>"R01AA012028", "link"=>"https://reporter.nih.gov/quickSearch/R01AA012028", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"1", "description"=>"Naltrexone plus Sertraline", "interventionNames"=>["Drug: naltrexone"]}, {"type"=>"EXPERIMENTAL", "label"=>"2", "description"=>"Naltrexone alone", "interventionNames"=>["Drug: sertraline", "Drug: naltrexone"]}], "interventions"=>[{"name"=>"sertraline", "type"=>"DRUG", "otherNames"=>["Zoloft"], "description"=>"16 week outpatient study", "armGroupLabels"=>["2"]}, {"name"=>"naltrexone", "type"=>"DRUG", "otherNames"=>["Revia"], "description"=>"16 week outpatient study", "armGroupLabels"=>["1", "2"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"New Haven", "state"=>"Connecticut", "country"=>"United States", "geoPoint"=>{"lat"=>41.30815, "lon"=>-72.92816}}], "overallOfficials"=>[{"name"=>"Dr. Stephanie O'Malley", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Yale University"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Yale University", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)", "class"=>"NIH"}]}}}
