Nctid:
NCT00000294
Payload:
{"FullStudy"=>{"Rank"=>499028, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "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"=>"M21841", "ConditionBrowseLeafName"=>"Cocaine-Related Disorders", "ConditionBrowseLeafAsFound"=>"Cocaine-Related Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"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"=>"D000077261", "InterventionMeshTerm"=>"Carvedilol"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000319", "InterventionAncestorTerm"=>"Adrenergic beta-Antagonists"}, {"InterventionAncestorId"=>"D000018674", "InterventionAncestorTerm"=>"Adrenergic Antagonists"}, {"InterventionAncestorId"=>"D000018663", "InterventionAncestorTerm"=>"Adrenergic Agents"}, {"InterventionAncestorId"=>"D000018377", "InterventionAncestorTerm"=>"Neurotransmitter Agents"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000000959", "InterventionAncestorTerm"=>"Antihypertensive Agents"}, {"InterventionAncestorId"=>"D000000975", "InterventionAncestorTerm"=>"Antioxidants"}, {"InterventionAncestorId"=>"D000020011", "InterventionAncestorTerm"=>"Protective Agents"}, {"InterventionAncestorId"=>"D000002121", "InterventionAncestorTerm"=>"Calcium Channel Blockers"}, {"InterventionAncestorId"=>"D000049990", "InterventionAncestorTerm"=>"Membrane Transport Modulators"}, {"InterventionAncestorId"=>"D000077264", "InterventionAncestorTerm"=>"Calcium-Regulating Hormones and Agents"}, {"InterventionAncestorId"=>"D000014665", "InterventionAncestorTerm"=>"Vasodilator Agents"}, {"InterventionAncestorId"=>"D000058668", "InterventionAncestorTerm"=>"Adrenergic alpha-1 Receptor Antagonists"}, {"InterventionAncestorId"=>"D000000317", "InterventionAncestorTerm"=>"Adrenergic alpha-Antagonists"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M1718", "InterventionBrowseLeafName"=>"Carvedilol", "InterventionBrowseLeafAsFound"=>"Circulating", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M6271", "InterventionBrowseLeafName"=>"Cocaine", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3671", "InterventionBrowseLeafName"=>"Adrenergic beta-Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20746", "InterventionBrowseLeafName"=>"Adrenergic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20755", "InterventionBrowseLeafName"=>"Adrenergic Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20504", "InterventionBrowseLeafName"=>"Neurotransmitter Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4277", "InterventionBrowseLeafName"=>"Antihypertensive Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4292", "InterventionBrowseLeafName"=>"Antioxidants", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M21869", "InterventionBrowseLeafName"=>"Protective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M5398", "InterventionBrowseLeafName"=>"Calcium, Dietary", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M5381", "InterventionBrowseLeafName"=>"Calcium", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M5384", "InterventionBrowseLeafName"=>"Calcium Channel Blockers", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9789", "InterventionBrowseLeafName"=>"Hormones", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17412", "InterventionBrowseLeafName"=>"Vasodilator Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M29194", "InterventionBrowseLeafName"=>"Adrenergic alpha-1 Receptor Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3669", "InterventionBrowseLeafName"=>"Adrenergic alpha-Antagonists", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Antihypertensive Agents", "InterventionBrowseBranchAbbrev"=>"AnAg"}, {"InterventionBrowseBranchName"=>"Channel Blockers", "InterventionBrowseBranchAbbrev"=>"ChanBlk"}, {"InterventionBrowseBranchName"=>"Vasodilator Agents", "InterventionBrowseBranchAbbrev"=>"VaDiAg"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Vasoconstrictor Agents", "InterventionBrowseBranchAbbrev"=>"VaCoAg"}, {"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}, {"InterventionBrowseBranchName"=>"Bone Density Conservation Agents", "InterventionBrowseBranchAbbrev"=>"BDCA"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignMaskingInfo"=>{"DesignMasking"=>"Double"}, "DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"0"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"September 1998"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"March 1999", "CompletionDateStruct"=>{"CompletionDate"=>"December 2001"}, "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"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Behavioral"}, {"PrimaryOutcomeMeasure"=>"Subjective"}, {"PrimaryOutcomeMeasure"=>"Physiologic measures"}]}}, "ConditionsModule"=>{"ConditionList"=>{"Condition"=>["Cocaine-Related Disorders"]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to examine carvedilol effects in response to cocaine.", "DetailedDescription"=>"The purpose of this study was to determine whether carvedilol, and alpha and beta adrenergic blocker, would inhibit the priming effect of cocaine in a laboratory model. A total of 12 subjects were enrolled in this double blind, placebo controlled, outpatient study. After an adaptation session, three experimental sessions were held, 2-9 days apart. On each of 3 experimental sessions, a single oral dose of low (25mg) or high dose of carvedilol (50mg) or placebo were administered. Two hours following carvedilol or placebo treatment, subjects received a priming dose of smoked cocaine, 0.4 mg/kg. during the second part of the session, subjects had the option to earn up to 2 tokens by working on a computer task that could later be exchanged for money or deliveries of cocaine. We proposed that blockage of adrenergic receptors by carvedilol would significantly alter the subjective and physiological effects of cocaine."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"55 years", "MinimumAge"=>"20 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nMale/Female between 20 and 55. History of smoked or intravenous cocaine use on the average of at least once a week over a 6 month period. current history of good health and normal EKG. Not pregnant as determined by pregnancy screening nor breast feeding, using acceptable birth control methods (e.g. birth control pills diaphragm, condoms plus foam)\n\nExclusion Criteria:\n\nCurrent problems with major psychiatric illnesses including bipolar disorder, schizophrenia, or anxiety disorders. History of major medical illnesses including asthma and chronic obstructive pulmonary disease. Currently on a drug related parole or probation. Treated for chemical dependency withing the past 6 months."}, "IdentificationModule"=>{"NCTId"=>"NCT00000294", "BriefTitle"=>"Effects of Carvedilol on Cocaine Use in Humans - 11", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute on Drug Abuse (NIDA)"}, "OfficialTitle"=>"Effects of Carvedilol on Cocaine Use in Humans", "OrgStudyIdInfo"=>{"OrgStudyId"=>"NIDA-09259-11"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"P50-09259-11"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Carvedilol", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"55455", "LocationCity"=>"Minneapolis", "LocationState"=>"Minnesota", "LocationCountry"=>"United States", "LocationFacility"=>"University of Minnesota"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Dorothy Hatsukami, Ph.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"University of Minnesota"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute on Drug Abuse (NIDA)", "LeadSponsorClass"=>"NIH"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"University of Minnesota", "CollaboratorClass"=>"OTHER"}]}}}}}}
