Nctid:
NCT00000251
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D019966", "term"=>"Substance-Related Disorders"}, {"id"=>"D009293", "term"=>"Opioid-Related Disorders"}], "ancestors"=>[{"id"=>"D064419", "term"=>"Chemically-Induced Disorders"}, {"id"=>"D001523", "term"=>"Mental Disorders"}, {"id"=>"D000079524", "term"=>"Narcotic-Related Disorders"}], "browseLeaves"=>[{"id"=>"M21837", "name"=>"Substance-Related Disorders", "asFound"=>"Substance-Related Disorders", "relevance"=>"HIGH"}, {"id"=>"M12244", "name"=>"Opioid-Related Disorders", "asFound"=>"Opioid-Related Disorders", "relevance"=>"HIGH"}, {"id"=>"M30302", "name"=>"Chemically-Induced Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M2057", "name"=>"Narcotic-Related 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"=>"D007530", "term"=>"Isoflurane"}], "ancestors"=>[{"id"=>"D018685", "term"=>"Anesthetics, Inhalation"}, {"id"=>"D018681", "term"=>"Anesthetics, General"}, {"id"=>"D000777", "term"=>"Anesthetics"}, {"id"=>"D002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M12546", "name"=>"Nitrous Oxide", "relevance"=>"LOW"}, {"id"=>"M10562", "name"=>"Isoflurane", "asFound"=>"IMT", "relevance"=>"HIGH"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M20765", "name"=>"Anesthetics, Inhalation", "relevance"=>"LOW"}, {"id"=>"M20761", "name"=>"Anesthetics, General", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>10}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1994-04"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2015-11", "completionDateStruct"=>{"date"=>"1996-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2015-11-30", "studyFirstSubmitDate"=>"1999-09-20", "studyFirstSubmitQcDate"=>"1999-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2015-12-02", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-09-21", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1996-01", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Logical reasoning test", "timeFrame"=>"15 & 30 min inhalation and 5, 30, & 60 min post inhalation"}, {"measure"=>"Free recall memory test", "timeFrame"=>"15 & 30 min inhalation and 5, 30, & 60 min post inhalation"}, {"measure"=>"Auditory reaction time", "timeFrame"=>"15 & 30 min inhalation and 5,30 & 60 min post inhalation"}, {"measure"=>"Digit symbol substitution test", "timeFrame"=>"2,15 & 30 min inhalation and 5,30 & 60 min post inhalation"}]}, "conditionsModule"=>{"keywords"=>["nitrous oxide", "isoflurane", "subjective effects", "psychomotor", "healthy volunteer", "drug interaction"], "conditions"=>["Opioid-Related Disorders", "Substance-Related Disorders"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8712393", "type"=>"BACKGROUND", "citation"=>"Zacny JP, Yajnik S, Lichtor JL, Klafta JM, Young CJ, Thapar P, Rupani G, Coalson DW, Apfelbaum JL. The acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations on cognitive and psychomotor performance in healthy volunteers. Anesth Analg. 1996 Jan;82(1):153-7. doi: 10.1097/00000539-199601000-00028."}, {"pmid"=>"29610659", "type"=>"DERIVED", "citation"=>"Whelan J, Hackshaw A, McTiernan A, Grimer R, Spooner D, Bate J, Ranft A, Paulussen M, Juergens H, Craft A, Lewis I. Survival is influenced by approaches to local treatment of Ewing sarcoma within an international randomised controlled trial: analysis of EICESS-92. Clin Sarcoma Res. 2018 Mar 30;8:6. doi: 10.1186/s13569-018-0093-y. eCollection 2018."}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To evaluate the acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations in healthy volunteers."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"32 years", "minimumAge"=>"21 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Please contact site for information."}, "identificationModule"=>{"nctId"=>"NCT00000251", "briefTitle"=>"Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Chicago"}, "officialTitle"=>"Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide", "orgStudyIdInfo"=>{"id"=>"NIDA-08391-3"}, "secondaryIdInfos"=>[{"id"=>"R01DA008391", "link"=>"https://reporter.nih.gov/quickSearch/R01DA008391", "type"=>"NIH"}, {"id"=>"R01-08391-3"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo", "description"=>"Subjects inhale 100% oxygen", "interventionNames"=>["Other: 100% oxygen"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"30% N2O", "description"=>"Subjects inhale 30% N2O", "interventionNames"=>["Drug: 30% N2O"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"0.2% isoflurane", "description"=>"Subjects inhale 0.2% isoflurane", "interventionNames"=>["Drug: 0.2% isoflurane"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"0.4% isoflurane", "description"=>"Subjects inhale 0.4% isoflurane", "interventionNames"=>["Drug: 0.4% isoflurane"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"0.2% isoflurane + 30% N2O", "description"=>"Subjects will inhale a combination of 0.2% isoflurane and 30% N2O", "interventionNames"=>["Drug: 30% N2O", "Drug: 0.2% isoflurane"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"0.4% isoflurane + 30% N2O", "description"=>"Subjects will inhale a combination of 0.4% isoflurane and 30% N2O", "interventionNames"=>["Drug: 30% N2O", "Drug: 0.4% isoflurane"]}], "interventions"=>[{"name"=>"30% N2O", "type"=>"DRUG", "armGroupLabels"=>["0.2% isoflurane + 30% N2O", "0.4% isoflurane + 30% N2O", "30% N2O"]}, {"name"=>"0.2% isoflurane", "type"=>"DRUG", "armGroupLabels"=>["0.2% isoflurane", "0.2% isoflurane + 30% N2O"]}, {"name"=>"0.4% isoflurane", "type"=>"DRUG", "armGroupLabels"=>["0.4% isoflurane", "0.4% isoflurane + 30% N2O"]}, {"name"=>"100% oxygen", "type"=>"OTHER", "description"=>"Placebo", "armGroupLabels"=>["Placebo"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"60637", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"University of Chicago, Anesthesia & Critical Care", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}], "overallOfficials"=>[{"name"=>"James Zacny, Ph.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Chicago"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Chicago", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institute on Drug Abuse (NIDA)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
