Nctid:
NCT00000451
Payload:
{"FullStudy"=>{"Rank"=>498875, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000000437", "ConditionMeshTerm"=>"Alcoholism"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000019973", "ConditionAncestorTerm"=>"Alcohol-Related Disorders"}, {"ConditionAncestorId"=>"D000019966", "ConditionAncestorTerm"=>"Substance-Related Disorders"}, {"ConditionAncestorId"=>"D000064419", "ConditionAncestorTerm"=>"Chemically-Induced Disorders"}, {"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M3783", "ConditionBrowseLeafName"=>"Alcoholism", "ConditionBrowseLeafAsFound"=>"Alcohol Dependence", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M21842", "ConditionBrowseLeafName"=>"Alcohol-Related Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M21837", "ConditionBrowseLeafName"=>"Substance-Related Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M30302", "ConditionBrowseLeafName"=>"Chemically-Induced Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4815", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14473", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Substance Related Disorders", "ConditionBrowseBranchAbbrev"=>"BC25"}, {"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000009271", "InterventionMeshTerm"=>"Naltrexone"}, {"InterventionMeshId"=>"D000020280", "InterventionMeshTerm"=>"Sertraline"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000427", "InterventionAncestorTerm"=>"Alcohol Deterrents"}, {"InterventionAncestorId"=>"D000009292", "InterventionAncestorTerm"=>"Narcotic Antagonists"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000018689", "InterventionAncestorTerm"=>"Sensory System Agents"}, {"InterventionAncestorId"=>"D000018373", "InterventionAncestorTerm"=>"Peripheral Nervous System Agents"}, {"InterventionAncestorId"=>"D000000928", "InterventionAncestorTerm"=>"Antidepressive Agents"}, {"InterventionAncestorId"=>"D000011619", "InterventionAncestorTerm"=>"Psychotropic Drugs"}, {"InterventionAncestorId"=>"D000017367", "InterventionAncestorTerm"=>"Selective Serotonin Reuptake Inhibitors"}, {"InterventionAncestorId"=>"D000014179", "InterventionAncestorTerm"=>"Neurotransmitter Uptake Inhibitors"}, {"InterventionAncestorId"=>"D000049990", "InterventionAncestorTerm"=>"Membrane Transport Modulators"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000018377", "InterventionAncestorTerm"=>"Neurotransmitter Agents"}, {"InterventionAncestorId"=>"D000018490", "InterventionAncestorTerm"=>"Serotonin Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M3777", "InterventionBrowseLeafName"=>"Ethanol", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M12222", "InterventionBrowseLeafName"=>"Naltrexone", "InterventionBrowseLeafAsFound"=>"General anesthesia", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M22100", "InterventionBrowseLeafName"=>"Sertraline", "InterventionBrowseLeafAsFound"=>"10%", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M12245", "InterventionBrowseLeafName"=>"Narcotics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M12243", "InterventionBrowseLeafName"=>"Narcotic Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4247", "InterventionBrowseLeafName"=>"Antidepressive Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M14474", "InterventionBrowseLeafName"=>"Psychotropic Drugs", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M15512", "InterventionBrowseLeafName"=>"Serotonin", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M19649", "InterventionBrowseLeafName"=>"Selective Serotonin Reuptake Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20504", "InterventionBrowseLeafName"=>"Neurotransmitter Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Alcohol Deterrents", "InterventionBrowseBranchAbbrev"=>"AlcDet"}, {"InterventionBrowseBranchName"=>"Narcotic Antagonists", "InterventionBrowseBranchAbbrev"=>"NarcAntag"}, {"InterventionBrowseBranchName"=>"Psychotropic Drugs", "InterventionBrowseBranchAbbrev"=>"PsychDr"}, {"InterventionBrowseBranchName"=>"Analgesics", "InterventionBrowseBranchAbbrev"=>"Analg"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Triple", "DesignWhoMaskedList"=>{"DesignWhoMasked"=>["Participant", "Care Provider", "Investigator"]}}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"198"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"January 2003"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"January 2013", "CompletionDateStruct"=>{"CompletionDate"=>"November 2005", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"January 28, 2013", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"November 2, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"January 29, 2013", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 3, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"August 2005", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Days abstinent"}]}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Alcoholism", "Alcohol Dependence"]}, "ConditionList"=>{"Condition"=>["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"=>{"Gender"=>"All", "MaximumAge"=>"65 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nAlaska Native having biological Alaska Native ancestry.\nMeets criteria for alcohol dependence.\nPrior to entering the study must be abstinent between 3 and 14 days and have a withdrawal assessment.\nStable residence to ensure that subjects can be located during the study.\n\nExclusion Criteria:\n\nCurrently meets criteria for abuse or dependence on substances other than alcohol or nicotine.\nCurrent use of disulfiram.\nPsychotic or otherwise severely psychiatrically disabled.\nUse of other psychotropic medications including antidepressants and anxiolytics.\nMedical 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.\nHepatocellular disease or elevated bilirubin levels.\nFemales who are pregnant, nursing, or not using a reliable method of birth control.\nProbation or parole requirements that might interfere with participation in the study.\nInvolvement in alcohol treatment other than provided by the study or AA.\nUse of monoamine oxidase inhibitors in the past month.\nCurrent use of Type 1C antiarrhythmics propafenone and flecainide."}, "IdentificationModule"=>{"NCTId"=>"NCT00000451", "BriefTitle"=>"Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"Yale University"}, "OfficialTitle"=>"Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives", "OrgStudyIdInfo"=>{"OrgStudyId"=>"NIAAAOMA12028"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01AA012028", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01AA012028", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"1", "ArmGroupDescription"=>"Naltrexone plus Sertraline", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: naltrexone"]}}, {"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"2", "ArmGroupDescription"=>"Naltrexone alone", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: sertraline", "Drug: naltrexone"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"sertraline", "InterventionType"=>"Drug", "InterventionDescription"=>"16 week outpatient study", "InterventionOtherNameList"=>{"InterventionOtherName"=>["Zoloft"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["2"]}}, {"InterventionName"=>"naltrexone", "InterventionType"=>"Drug", "InterventionDescription"=>"16 week outpatient study", "InterventionOtherNameList"=>{"InterventionOtherName"=>["Revia"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["1", "2"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationCity"=>"New Haven", "LocationState"=>"Connecticut", "LocationCountry"=>"United States"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Dr. Stephanie O'Malley", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"Yale University"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"Yale University", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)", "CollaboratorClass"=>"NIH"}]}}}}}}
