Nctid:
NCT00000349
Payload:
{"FullStudy"=>{"Rank"=>475255, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000019970", "ConditionMeshTerm"=>"Cocaine-Related Disorders"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000019966", "ConditionAncestorTerm"=>"Substance-Related Disorders"}, {"ConditionAncestorId"=>"D000064419", "ConditionAncestorTerm"=>"Chemically-Induced Disorders"}, {"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M21531", "ConditionBrowseLeafName"=>"Cocaine-Related Disorders", "ConditionBrowseLeafAsFound"=>"Cocaine-Related Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M21527", "ConditionBrowseLeafName"=>"Substance-Related Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M29992", "ConditionBrowseLeafName"=>"Chemically-Induced Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14163", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4505", "ConditionBrowseLeafName"=>"Mental 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"=>"D000005475", "InterventionMeshTerm"=>"Flupenthixol"}, {"InterventionMeshId"=>"C000007761", "InterventionMeshTerm"=>"Flupenthixol decanoate"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000014150", "InterventionAncestorTerm"=>"Antipsychotic Agents"}, {"InterventionAncestorId"=>"D000014149", "InterventionAncestorTerm"=>"Tranquilizing Agents"}, {"InterventionAncestorId"=>"D000002492", "InterventionAncestorTerm"=>"Central Nervous System Depressants"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000011619", "InterventionAncestorTerm"=>"Psychotropic Drugs"}, {"InterventionAncestorId"=>"D000018492", "InterventionAncestorTerm"=>"Dopamine Antagonists"}, {"InterventionAncestorId"=>"D000015259", "InterventionAncestorTerm"=>"Dopamine Agents"}, {"InterventionAncestorId"=>"D000018377", "InterventionAncestorTerm"=>"Neurotransmitter Agents"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M5961", "InterventionBrowseLeafName"=>"Cocaine", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8293", "InterventionBrowseLeafName"=>"Flupenthixol", "InterventionBrowseLeafAsFound"=>"Peripheral nerve stimulator", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M179901", "InterventionBrowseLeafName"=>"Flupenthixol decanoate", "InterventionBrowseLeafAsFound"=>"Peripheral nerve stimulator", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M16594", "InterventionBrowseLeafName"=>"Antipsychotic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M14164", "InterventionBrowseLeafName"=>"Psychotropic Drugs", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7163", "InterventionBrowseLeafName"=>"Dopamine", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20286", "InterventionBrowseLeafName"=>"Dopamine Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17652", "InterventionBrowseLeafName"=>"Dopamine Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20194", "InterventionBrowseLeafName"=>"Neurotransmitter Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Vasoconstrictor Agents", "InterventionBrowseBranchAbbrev"=>"VaCoAg"}, {"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Psychotropic Drugs", "InterventionBrowseBranchAbbrev"=>"PsychDr"}, {"InterventionBrowseBranchName"=>"Cardiotonic Agents", "InterventionBrowseBranchAbbrev"=>"CaAg"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"0"}}, "StatusModule"=>{"OverallStatus"=>"Unknown status", "LastKnownStatus"=>"Active, not recruiting", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"December 2002", "LastUpdateSubmitDate"=>"January 10, 2017", "StudyFirstSubmitDate"=>"September 20, 1999", "StudyFirstSubmitQCDate"=>"September 20, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"January 11, 2017", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"September 21, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Degree of drug craving"}, {"PrimaryOutcomeMeasure"=>"History, incidence and amount of drug use"}, {"PrimaryOutcomeMeasure"=>"Type and severity of stimulant withdrawal symptoms"}, {"PrimaryOutcomeMeasure"=>"Characterization of study population"}, {"PrimaryOutcomeMeasure"=>"Population incidence of symptoms of depression, po"}, {"PrimaryOutcomeMeasure"=>"Frequency and intensity of drug use and sexual beh"}, {"PrimaryOutcomeMeasure"=>"Evidence of change in neurophysiology and brain ac"}, {"PrimaryOutcomeMeasure"=>"Evidence of change in subjective responses to coca"}, {"PrimaryOutcomeMeasure"=>"Clinical physiological response to cocaine challen"}, {"PrimaryOutcomeMeasure"=>"Degree to which study medication influences change"}]}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["cocaine dependence"]}, "ConditionList"=>{"Condition"=>["Cocaine-Related Disorders"]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to evaluate clinical safety issues pertaining to flupenthixol, to cocaine, and to their interaction, and to determine how pretreatment with flupenthixol modifies the subjective as well as physiological effects of cocaine. Taken together, these relatively D-1 selective agents can help determine the extent to which DA-1 binding affects the reinforcing effects of stimulants."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"50 years", "MinimumAge"=>"21 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nM/F, ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.\n\nExclusion Criteria:\n\nPsychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe."}, "IdentificationModule"=>{"NCTId"=>"NCT00000349", "BriefTitle"=>"Infusion Laboratory: Protocol 5 (Flupenthixol) - 14", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute on Drug Abuse (NIDA)"}, "OfficialTitle"=>"Infusion Laboratory: Protocol 5 (Flupenthixol)", "OrgStudyIdInfo"=>{"OrgStudyId"=>"NIDA-3-0010-14"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"Y01-3-0010-14"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Flupenthixol", "InterventionType"=>"Drug"}]}}, "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"=>"National Institute on Drug Abuse (NIDA)", "LeadSponsorClass"=>"NIH"}}}}}}
