Nctid:
NCT00000254
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "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"=>"M12244", "name"=>"Opioid-Related Disorders", "asFound"=>"Opioid-Related Disorders", "relevance"=>"HIGH"}, {"id"=>"M21837", "name"=>"Substance-Related Disorders", "asFound"=>"Substance-Related Disorders", "relevance"=>"HIGH"}, {"id"=>"M30302", "name"=>"Chemically-Induced Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic 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"=>"D009609", "term"=>"Nitrous Oxide"}, {"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"}, {"id"=>"D018712", "term"=>"Analgesics, Non-Narcotic"}, {"id"=>"D000700", "term"=>"Analgesics"}, {"id"=>"D018689", "term"=>"Sensory System Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}], "browseLeaves"=>[{"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M12546", "name"=>"Nitrous Oxide", "asFound"=>"Propionate", "relevance"=>"HIGH"}, {"id"=>"M10562", "name"=>"Isoflurane", "asFound"=>"Research Study", "relevance"=>"HIGH"}, {"id"=>"M20761", "name"=>"Anesthetics, General", "relevance"=>"LOW"}, {"id"=>"M20765", "name"=>"Anesthetics, Inhalation", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M20786", "name"=>"Analgesics, Non-Narcotic", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}]}}, "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"=>"1995-01"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2015-05", "completionDateStruct"=>{"date"=>"1995-09", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2015-05-26", "studyFirstSubmitDate"=>"1999-09-20", "studyFirstSubmitQcDate"=>"1999-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2015-05-28", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-09-21", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1995-09", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Pain response", "timeFrame"=>"Post inhalation", "description"=>"Effects of inhaled isoflurane on pain from immersion of subject's arm in ice cold water. Nitrous oxide (40%) was used as a positive control to confirm sensitivity of the pain assay."}]}, "conditionsModule"=>{"keywords"=>["isoflurane", "general anesthetic", "inhalant", "subjective effects", "healthy volunteer"], "conditions"=>["Opioid-Related Disorders", "Substance-Related Disorders"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Anesthesiology, 1995, 83: A287"}]}, "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 test the hypothesis that isoflurane at subanesthetic concentrations does not reduce cold-water immersion pain in healthy volunteers."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT"], "maximumAge"=>"34 years", "minimumAge"=>"21 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Please contact site for information."}, "identificationModule"=>{"nctId"=>"NCT00000254", "briefTitle"=>"Isoflurane at Subanesthetic Concentrations - 6", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Chicago"}, "officialTitle"=>"Isoflurane at Subanesthetic Concentrations", "orgStudyIdInfo"=>{"id"=>"NIDA-08391-6"}, "secondaryIdInfos"=>[{"id"=>"R01DA008391", "link"=>"https://reporter.nih.gov/quickSearch/R01DA008391", "type"=>"NIH"}, {"id"=>"R01-08391-6"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"SHAM_COMPARATOR", "label"=>"0% isoflurane", "interventionNames"=>["Drug: 40% Nitrous oxide", "Other: Sham comparator"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"0.2% isoflurane", "interventionNames"=>["Drug: 40% Nitrous oxide", "Drug: 0.2% isoflurane"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"0.4% isoflurane", "interventionNames"=>["Drug: 40% Nitrous oxide", "Drug: 0.4% isoflurane"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"0.6% isoflurane", "interventionNames"=>["Drug: 40% Nitrous oxide", "Drug: 0.6% isoflurane"]}], "interventions"=>[{"name"=>"40% Nitrous oxide", "type"=>"DRUG", "description"=>"Used as pain assay positive control", "armGroupLabels"=>["0% isoflurane", "0.2% isoflurane", "0.4% isoflurane", "0.6% isoflurane"]}, {"name"=>"Sham comparator", "type"=>"OTHER", "description"=>"0% isoflurane in oxygen", "armGroupLabels"=>["0% isoflurane"]}, {"name"=>"0.2% isoflurane", "type"=>"DRUG", "armGroupLabels"=>["0.2% isoflurane"]}, {"name"=>"0.4% isoflurane", "type"=>"DRUG", "armGroupLabels"=>["0.4% isoflurane"]}, {"name"=>"0.6% isoflurane", "type"=>"DRUG", "armGroupLabels"=>["0.6% isoflurane"]}]}, "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"}}}}