Nctid:
NCT00000318
Payload:
{"FullStudy"=>{"Rank"=>474572, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 01, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000019966", "ConditionMeshTerm"=>"Substance-Related Disorders"}, {"ConditionMeshId"=>"D000009293", "ConditionMeshTerm"=>"Opioid-Related Disorders"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000064419", "ConditionAncestorTerm"=>"Chemically-Induced Disorders"}, {"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}, {"ConditionAncestorId"=>"D000079524", "ConditionAncestorTerm"=>"Narcotic-Related Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M11934", "ConditionBrowseLeafName"=>"Opioid-Related Disorders", "ConditionBrowseLeafAsFound"=>"Opioid-Related Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M21527", "ConditionBrowseLeafName"=>"Substance-Related Disorders", "ConditionBrowseLeafAsFound"=>"Substance-Related Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M29992", "ConditionBrowseLeafName"=>"Chemically-Induced Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4505", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14163", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2057", "ConditionBrowseLeafName"=>"Narcotic-Related 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"=>"D000002047", "InterventionMeshTerm"=>"Buprenorphine"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000701", "InterventionAncestorTerm"=>"Analgesics, Opioid"}, {"InterventionAncestorId"=>"D000009294", "InterventionAncestorTerm"=>"Narcotics"}, {"InterventionAncestorId"=>"D000002492", "InterventionAncestorTerm"=>"Central Nervous System Depressants"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000000700", "InterventionAncestorTerm"=>"Analgesics"}, {"InterventionAncestorId"=>"D000018689", "InterventionAncestorTerm"=>"Sensory System Agents"}, {"InterventionAncestorId"=>"D000018373", "InterventionAncestorTerm"=>"Peripheral Nervous System Agents"}, {"InterventionAncestorId"=>"D000009292", "InterventionAncestorTerm"=>"Narcotic Antagonists"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M5007", "InterventionBrowseLeafName"=>"Buprenorphine", "InterventionBrowseLeafAsFound"=>"Ischemic", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3723", "InterventionBrowseLeafName"=>"Analgesics, Opioid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3722", "InterventionBrowseLeafName"=>"Analgesics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M11935", "InterventionBrowseLeafName"=>"Narcotics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M11933", "InterventionBrowseLeafName"=>"Narcotic Antagonists", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Analgesics", "InterventionBrowseBranchAbbrev"=>"Analg"}, {"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}, {"InterventionBrowseBranchName"=>"Narcotic Antagonists", "InterventionBrowseBranchAbbrev"=>"NarcAntag"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Factorial Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"202"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"December 1994"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"December 2008", "CompletionDateStruct"=>{"CompletionDate"=>"August 2007", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"January 11, 2017", "StudyFirstSubmitDate"=>"September 20, 1999", "StudyFirstSubmitQCDate"=>"September 20, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"January 12, 2017", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"September 21, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"March 2004", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Opioid and cocaine use", "PrimaryOutcomeTimeFrame"=>"26 weeks"}, {"PrimaryOutcomeMeasure"=>"Social and psychological functioning", "PrimaryOutcomeTimeFrame"=>"26 weeks"}, {"PrimaryOutcomeMeasure"=>"AIDS risk behavior", "PrimaryOutcomeTimeFrame"=>"26 weeks"}]}}, "OversightModule"=>{"OversightHasDMC"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["opioid dependence"]}, "ConditionList"=>{"Condition"=>["Opioid-Related Disorders", "Substance-Related Disorders"]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to assess optimal dosage of buprenorphine on a thrice weekly schedule in a pilot clinical trial."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"55 years", "MinimumAge"=>"21 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Please contact site for information."}, "IdentificationModule"=>{"NCTId"=>"NCT00000318", "BriefTitle"=>"Buprenorphine Maintenance Dose Schedule and Treatment Setting - 1", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute on Drug Abuse (NIDA)"}, "OfficialTitle"=>"Buprenorphine Maintenance Dose Schedule and Treatment Setting: Pilot", "OrgStudyIdInfo"=>{"OrgStudyId"=>"NIDA-09803-1"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01-09803-1"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"1", "ArmGroupDescription"=>"Maintenance treatment with daily medication", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Buprenorphine"]}}, {"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"2", "ArmGroupDescription"=>"Maintenance treatment with thrice-weekly medication", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Buprenorphine"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Buprenorphine", "InterventionType"=>"Drug", "InterventionDescription"=>"Experimental Maintenance treatment with daily medication\nExperimental Maintenance treatment with thrice-weekly medication", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["1", "2"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"06519", "LocationCity"=>"New Haven", "LocationState"=>"Connecticut", "LocationCountry"=>"United States", "LocationFacility"=>"APT Residential Services Division"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Richard Schottenfeld, M.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"Yale University"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute on Drug Abuse (NIDA)", "LeadSponsorClass"=>"NIH"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"Yale University", "CollaboratorClass"=>"OTHER"}]}, "ResponsibleParty"=>{"ResponsiblePartyOldNameTitle"=>"Richard S. Schottenfeld, MD", "ResponsiblePartyOldOrganization"=>"Yale University School of Medicine"}}}}}}