Nctid:
NCT00000339
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D019970", "term"=>"Cocaine-Related Disorders"}], "ancestors"=>[{"id"=>"D019966", "term"=>"Substance-Related Disorders"}, {"id"=>"D064419", "term"=>"Chemically-Induced Disorders"}, {"id"=>"D001523", "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"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental 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"=>"D018967", "term"=>"Risperidone"}], "ancestors"=>[{"id"=>"D012702", "term"=>"Serotonin Antagonists"}, {"id"=>"D018490", "term"=>"Serotonin Agents"}, {"id"=>"D018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D014150", "term"=>"Antipsychotic Agents"}, {"id"=>"D014149", "term"=>"Tranquilizing Agents"}, {"id"=>"D002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D011619", "term"=>"Psychotropic Drugs"}, {"id"=>"D018492", "term"=>"Dopamine Antagonists"}, {"id"=>"D015259", "term"=>"Dopamine Agents"}], "browseLeaves"=>[{"id"=>"M20999", "name"=>"Risperidone", "asFound"=>"Operation", "relevance"=>"HIGH"}, {"id"=>"M6271", "name"=>"Cocaine", "relevance"=>"LOW"}, {"id"=>"M15512", "name"=>"Serotonin", "relevance"=>"LOW"}, {"id"=>"M15513", "name"=>"Serotonin Antagonists", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}, {"id"=>"M16904", "name"=>"Antipsychotic Agents", "relevance"=>"LOW"}, {"id"=>"M14474", "name"=>"Psychotropic Drugs", "relevance"=>"LOW"}, {"id"=>"M7473", "name"=>"Dopamine", "relevance"=>"LOW"}, {"id"=>"M20596", "name"=>"Dopamine Antagonists", "relevance"=>"LOW"}, {"id"=>"M17962", "name"=>"Dopamine Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Vasoconstrictor Agents", "abbrev"=>"VaCoAg"}, {"name"=>"Cardiotonic Agents", "abbrev"=>"CaAg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"SINGLE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"count"=>13}}, "statusModule"=>{"overallStatus"=>"UNKNOWN", "lastKnownStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"1996-06"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1996-06", "lastUpdateSubmitDate"=>"2017-01-10", "studyFirstSubmitDate"=>"1999-09-20", "studyFirstSubmitQcDate"=>"1999-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2017-01-11", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-09-21", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Evidence of change in neurotoxicity based on chore"}, {"measure"=>"Degree of drug craving"}, {"measure"=>"History, incidence and amount of drug use"}, {"measure"=>"Type and severity of stimulant withdrawal symptoms"}, {"measure"=>"Characterization of study population"}, {"measure"=>"Population incidence of symptoms of depression, po"}, {"measure"=>"Frequency and intensity of drug use and sexual beh"}, {"measure"=>"Evidence of change in subjective responses to coca"}, {"measure"=>"Clinical physiological response to cocaine challen"}, {"measure"=>"Degree to which study medication influences change"}]}, "conditionsModule"=>{"keywords"=>["cocaine dependence"], "conditions"=>["Cocaine-Related Disorders"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to evaluate clinical safety issues pertaining to risperidone, to cocaine and to its interaction, and to determine how pretreatment with risperidone modifies the subjective as well as physiological effects of cocaine."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"50 years", "minimumAge"=>"21 years", "healthyVolunteers"=>false, "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"=>"NCT00000339", "briefTitle"=>"Infusion Laboratory: Protocol 3 (Risperidone) - 4", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute on Drug Abuse (NIDA)"}, "officialTitle"=>"Infusion Laboratory: Protocol 3 (Risperidone)", "orgStudyIdInfo"=>{"id"=>"NIDA-3-0010-4"}, "secondaryIdInfos"=>[{"id"=>"Y01-3-0010-4"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Risperidone", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90025", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Friends Research Institute", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}], "overallOfficials"=>[{"name"=>"Walter Ling, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Friends Research Institute, Inc."}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute on Drug Abuse (NIDA)", "class"=>"NIH"}}}}
