Nctid:
NCT00000290
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000019970", "term"=>"Cocaine-Related Disorders"}], "ancestors"=>[{"id"=>"D000019966", "term"=>"Substance-Related Disorders"}, {"id"=>"D000064419", "term"=>"Chemically-Induced Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M21841", "name"=>"Cocaine-Related Disorders", "asFound"=>"Cocaine-Related Disorders", "relevance"=>"HIGH"}, {"id"=>"M21837", "name"=>"Substance-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M30302", "name"=>"Chemically-Induced Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Substance Related Disorders", "abbrev"=>"BC25"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000003042", "term"=>"Cocaine"}], "ancestors"=>[{"id"=>"D000000779", "term"=>"Anesthetics, Local"}, {"id"=>"D000000777", "term"=>"Anesthetics"}, {"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000014662", "term"=>"Vasoconstrictor Agents"}, {"id"=>"D000018765", "term"=>"Dopamine Uptake Inhibitors"}, {"id"=>"D000014179", "term"=>"Neurotransmitter Uptake Inhibitors"}, {"id"=>"D000049990", "term"=>"Membrane Transport Modulators"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000015259", "term"=>"Dopamine Agents"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}], "browseLeaves"=>[{"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M6271", "name"=>"Cocaine", "asFound"=>"Anakinra", "relevance"=>"HIGH"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M4109", "name"=>"Anesthetics, Local", "relevance"=>"LOW"}, {"id"=>"M17409", "name"=>"Vasoconstrictor Agents", "relevance"=>"LOW"}, {"id"=>"M7473", "name"=>"Dopamine", "relevance"=>"LOW"}, {"id"=>"M20832", "name"=>"Dopamine Uptake Inhibitors", "relevance"=>"LOW"}, {"id"=>"M17962", "name"=>"Dopamine Agents", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Vasoconstrictor Agents", "abbrev"=>"VaCoAg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Cardiotonic Agents", "abbrev"=>"CaAg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"count"=>0}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1997-05"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2016-11", "completionDateStruct"=>{"date"=>"2001-12"}, "lastUpdateSubmitDate"=>"2017-01-11", "studyFirstSubmitDate"=>"1999-09-20", "studyFirstSubmitQcDate"=>"1999-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2017-01-12", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-09-21", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Physiological measures"}, {"measure"=>"Biochemical"}]}, "conditionsModule"=>{"keywords"=>["cocaine dependence"], "conditions"=>["Cocaine-Related Disorders"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Presented at CPDD, 6/13/99. None"}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to determine the HPA axis and adrenergic system activation in response to cocaine administration.", "detailedDescription"=>"The goal of this study was to investigate the role of sympathetic-adrenal medullary (SAM) and hy0pothalamo-pituitary-adrenal (HPA) systems in mediating the addictive effects of cocaine. A toal of 6 male subjects were enrolled for this 5 day inpatient study. Subjects were assigned to either cocaine (32mg /70kg iv) or placebo (saline iv) treatment during the first experimental sessions and were crossed over to the alternative treatment during the second experimental session. Endpoints that were followed during the experimental sessions included neuroendocrine (serum epinephrine, norepinephrine and cortisol levels), physological (heart rate/blood pressure, EKG) and subjective measures (Beck Depression Inventory, Craving Questionnaire). We hypothesized that cocaine administration would lead to increased blood levels of norpinephrine, epinephrine and cortisol in cocaine dependent subjects."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT"], "maximumAge"=>"45 years", "minimumAge"=>"20 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nMales between the ages of 20-45. 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.\n\nExclusion Criteria:\n\nHistory of suicide attempt, bipolar disorder, schizophrenia, or generalized anxiety disorder. Current problem with major depressive disorder. Current use of alcohol or other drugs on a daily basis. History of major medical illnesses. Currently on parole, probation or a legal history of violence. Treatment for chemical dependency within the past 6 months. History of sensitivity to tricyclic compounds or other prescription drugs. Use of any psychotropic drugs including MAOIs in the past 6 months."}, "identificationModule"=>{"nctId"=>"NCT00000290", "briefTitle"=>"Stress Hormones and Human Cocaine Use - 7", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute on Drug Abuse (NIDA)"}, "officialTitle"=>"Stress Hormones and Human Cocaine Use", "orgStudyIdInfo"=>{"id"=>"NIDA-09259-7"}, "secondaryIdInfos"=>[{"id"=>"P50-09259-7"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Cocaine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"55455", "city"=>"Minneapolis", "state"=>"Minnesota", "country"=>"United States", "facility"=>"University of Minnesota", "geoPoint"=>{"lat"=>44.97997, "lon"=>-93.26384}}], "overallOfficials"=>[{"name"=>"Dorothy Hatsukami, Ph.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Minnesota"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute on Drug Abuse (NIDA)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"University of Minnesota", "class"=>"OTHER"}]}}}
