Nctid:
NCT00000299
Payload:
{"FullStudy"=>{"Rank"=>474096, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"November 27, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000009293", "ConditionMeshTerm"=>"Opioid-Related Disorders"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000079524", "ConditionAncestorTerm"=>"Narcotic-Related Disorders"}, {"ConditionAncestorId"=>"D000019966", "ConditionAncestorTerm"=>"Substance-Related Disorders"}, {"ConditionAncestorId"=>"D000064419", "ConditionAncestorTerm"=>"Chemically-Induced Disorders"}, {"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M11934", "ConditionBrowseLeafName"=>"Opioid-Related Disorders", "ConditionBrowseLeafAsFound"=>"Opioid-Related Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M2057", "ConditionBrowseLeafName"=>"Narcotic-Related Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M21527", "ConditionBrowseLeafName"=>"Substance-Related Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M29992", "ConditionBrowseLeafName"=>"Chemically-Induced Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4505", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14163", "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"=>"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"=>"M11912", "InterventionBrowseLeafName"=>"Naltrexone", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M5007", "InterventionBrowseLeafName"=>"Buprenorphine", "InterventionBrowseLeafAsFound"=>"Iron", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M11911", "InterventionBrowseLeafName"=>"Naloxone", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3723", "InterventionBrowseLeafName"=>"Analgesics, Opioid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M27061", "InterventionBrowseLeafName"=>"Opiate Alkaloids", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3722", "InterventionBrowseLeafName"=>"Analgesics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M11935", "InterventionBrowseLeafName"=>"Narcotics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M11933", "InterventionBrowseLeafName"=>"Narcotic Antagonists", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Alcohol Deterrents", "InterventionBrowseBranchAbbrev"=>"AlcDet"}, {"InterventionBrowseBranchName"=>"Narcotic Antagonists", "InterventionBrowseBranchAbbrev"=>"NarcAntag"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Analgesics", "InterventionBrowseBranchAbbrev"=>"Analg"}, {"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Single", "DesignWhoMaskedList"=>{"DesignWhoMasked"=>["Participant"]}}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Crossover Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"12"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"October 2008"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"January 2016", "CompletionDateStruct"=>{"CompletionDate"=>"November 2009", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"January 27, 2016", "StudyFirstSubmitDate"=>"September 20, 1999", "StudyFirstSubmitQCDate"=>"September 20, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"January 29, 2016", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"September 21, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"November 2009", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Opiate craving", "PrimaryOutcomeTimeFrame"=>"10 test days", "PrimaryOutcomeDescription"=>"opiate craving is measured on each test day."}, {"PrimaryOutcomeMeasure"=>"Opiate withdrawal symptoms", "PrimaryOutcomeTimeFrame"=>"10 test days", "PrimaryOutcomeDescription"=>"opiate withdrawal symptoms are documented for each test day"}]}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Opioid-Related Disorders"]}, "ConditionList"=>{"Condition"=>["Opioid-Related Disorders"]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to develop a clinical protocol to detoxify patients from opiates to naltrexone using buprenorphine and to develop pilot data for a grant application for a controlled study of the efficacy of the new clinical protocol for outpatients."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"50 years", "MinimumAge"=>"21 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nMales/Females, ages 21-50. Opiate dependence according to DSM-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.\n\nExclusion Criteria:\n\npsychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependent on etoh or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe."}, "IdentificationModule"=>{"NCTId"=>"NCT00000299", "BriefTitle"=>"Rapid Opiate Detoxification and Naltrexone Induction Using Buprenorphine - 2", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"University of California, Los Angeles"}, "OfficialTitle"=>"Rapid Opiate Detoxification & Naltrexone Induction Using Bup.", "OrgStudyIdInfo"=>{"OrgStudyId"=>"NIDA-09260-2"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"P50DA009260", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/P50DA009260", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"P50-09260-2"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"buprenorphine", "ArmGroupDescription"=>"depot buprenorphine", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Buprenorphine"]}}, {"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"buprenorphine and ultra-low dose naloxone", "ArmGroupDescription"=>"depot buprenorphine and naloxone", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Buprenorphine"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Buprenorphine", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["buprenorphine", "buprenorphine and ultra-low dose naloxone"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"90025", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Friends Research Institute"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Walter Ling, M.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"Friends Research Institute, Inc."}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"University of California, Los Angeles", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute on Drug Abuse (NIDA)", "CollaboratorClass"=>"NIH"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Principal Investigator", "ResponsiblePartyInvestigatorTitle"=>"PI", "ResponsiblePartyInvestigatorFullName"=>"Walter Ling", "ResponsiblePartyInvestigatorAffiliation"=>"University of California, Los Angeles"}}}}}}
