Nctid:
NCT00000337
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"=>"D000012642", "term"=>"Selegiline"}], "ancestors"=>[{"id"=>"D000000928", "term"=>"Antidepressive Agents"}, {"id"=>"D000011619", "term"=>"Psychotropic Drugs"}, {"id"=>"D000000978", "term"=>"Antiparkinson Agents"}, {"id"=>"D000018726", "term"=>"Anti-Dyskinesia Agents"}, {"id"=>"D000008996", "term"=>"Monoamine Oxidase Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000018696", "term"=>"Neuroprotective Agents"}, {"id"=>"D000020011", "term"=>"Protective Agents"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M6271", "name"=>"Cocaine", "relevance"=>"LOW"}, {"id"=>"M15454", "name"=>"Selegiline", "asFound"=>"Auditory stimulation", "relevance"=>"HIGH"}, {"id"=>"M4247", "name"=>"Antidepressive Agents", "relevance"=>"LOW"}, {"id"=>"M14474", "name"=>"Psychotropic Drugs", "relevance"=>"LOW"}, {"id"=>"M4295", "name"=>"Antiparkinson Agents", "relevance"=>"LOW"}, {"id"=>"M11960", "name"=>"Monoamine Oxidase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M20773", "name"=>"Neuroprotective Agents", "relevance"=>"LOW"}, {"id"=>"M21869", "name"=>"Protective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Vasoconstrictor Agents", "abbrev"=>"VaCoAg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Dyskinesia Agents", "abbrev"=>"AnDyAg"}, {"name"=>"Neuroprotective Agents", "abbrev"=>"NeuroAg"}, {"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>0}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1994-11"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1996-08", "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"=>"Degree of drug craving"}, {"measure"=>"History, incidence and amount of drug use"}, {"measure"=>"Type and severity of stimulant withdrawal symptoms"}, {"measure"=>"Population incidence of symptoms of depression, possible organic brain syndrome deficits"}, {"measure"=>"Frequency and intensity of drug use and sexual behaviors at risk for HIV"}, {"measure"=>"Evidence of change in neurophysiology and brain activity"}, {"measure"=>"Evidence of change in subjective responses to cocaine challenge"}, {"measure"=>"Clinical physiological response to cocaine challenge - especially adverse effects measures"}, {"measure"=>"Degree to which study medication influences changes in #6, 7 & 8 above (possible efficacy measure)"}, {"measure"=>"Characterization of study population"}]}, "conditionsModule"=>{"keywords"=>["cocaine dependence"], "conditions"=>["Cocaine-Related Disorders"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"1996 CPDD: \"Acute cocaine administration reverses EEG signs of cocaine withdrawal.\". 1996 CPDD: \"Acute cocaine administration reverses EEG signs of cocaine withdrawal.\""}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to determine the effects of selegiline on the subjective and physiological effects of cocaine challenge in chronic crack abusers, and to evaluate clinical safety issues pertaining to selegeline, to cocaine and their interaction in a chronic crack dependent population.", "detailedDescription"=>"To develop a medication for the treatment of cocaine addiction using a medical human physio-neuro-psycho-immunology laboratory setting. To characterize this cocaine abusing population on a variety of psychological and physicologically measures over time from withdrawal through pere and post cocaine administration. To determine the effects of selegeline on the subjective and physiological effects of cocaine challenge in chronic crack abusers. To evaluate clinical safety issues pertaining to selegeline, to cocaine and their interaction in a chronic crack dependent population."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"47 years", "minimumAge"=>"31 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"=>"NCT00000337", "briefTitle"=>"Infusion Laboratory: Protocol 1 - Selegeline - 2", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute on Drug Abuse (NIDA)"}, "officialTitle"=>"Infusion Laboratory: Protocol 1 - Selegeline", "orgStudyIdInfo"=>{"id"=>"NIDA-3-0010-2"}, "secondaryIdInfos"=>[{"id"=>"Y01-3-0010-2"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Selegiline", "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"}}}}