Nctid:
NCT00000262
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-21"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000019966", "term"=>"Substance-Related Disorders"}, {"id"=>"D000009293", "term"=>"Opioid-Related Disorders"}], "ancestors"=>[{"id"=>"D000064419", "term"=>"Chemically-Induced Disorders"}, {"id"=>"D000001523", "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"=>"M27137", "name"=>"Respiratory Aspiration", "relevance"=>"LOW"}, {"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"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000009609", "term"=>"Nitrous Oxide"}, {"id"=>"D000077149", "term"=>"Sevoflurane"}], "ancestors"=>[{"id"=>"D000010975", "term"=>"Platelet Aggregation Inhibitors"}, {"id"=>"D000018685", "term"=>"Anesthetics, Inhalation"}, {"id"=>"D000018681", "term"=>"Anesthetics, General"}, {"id"=>"D000000777", "term"=>"Anesthetics"}, {"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000018712", "term"=>"Analgesics, Non-Narcotic"}, {"id"=>"D000000700", "term"=>"Analgesics"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}], "browseLeaves"=>[{"id"=>"M1673", "name"=>"Sevoflurane", "asFound"=>"Laboratory", "relevance"=>"HIGH"}, {"id"=>"M12546", "name"=>"Nitrous Oxide", "asFound"=>"Oxygen therapy", "relevance"=>"HIGH"}, {"id"=>"M13865", "name"=>"Platelet Aggregation Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M20765", "name"=>"Anesthetics, Inhalation", "relevance"=>"LOW"}, {"id"=>"M20761", "name"=>"Anesthetics, General", "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"=>"Platelet Aggregation Inhibitors", "abbrev"=>"PlAggInh"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>20}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1996-11"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2015-05", "completionDateStruct"=>{"date"=>"1999-02", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2015-05-26", "studyFirstSubmitDate"=>"1999-09-20", "studyFirstSubmitQcDate"=>"1999-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2015-05-27", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-09-21", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1999-02", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Pain intensity, pain bothersomeness", "timeFrame"=>"During inhalation", "description"=>"Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4"}, {"measure"=>"Mood", "timeFrame"=>"During inhalation", "description"=>"Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4"}, {"measure"=>"Psychomotor performance", "timeFrame"=>"During inhalation", "description"=>"Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4"}]}, "conditionsModule"=>{"keywords"=>["nitrous oxide", "sevoflurane", "drug interaction", "subjective effects", "analgesia", "healthy volunteers"], "conditions"=>["Opioid-Related Disorders", "Substance-Related Disorders"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to determine the effects of combined sevoflurane and nitrous oxide inhalation on mood, psychomotor performance, and the pain response in humans."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Please contact site for information."}, "identificationModule"=>{"nctId"=>"NCT00000262", "briefTitle"=>"Effects of Combined Sevoflurane and Nitrous Oxide Inhalation - 14", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Chicago"}, "officialTitle"=>"Effects of Combined Sevoflurane and Nitrous Oxide Inhalation", "orgStudyIdInfo"=>{"id"=>"NIDA-08391-14"}, "secondaryIdInfos"=>[{"id"=>"R01DA008391", "link"=>"https://reporter.nih.gov/quickSearch/R01DA008391", "type"=>"NIH"}, {"id"=>"R01-08391-14"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo +/- 30% Nitrous oxide", "interventionNames"=>["Drug: 30% Nitrous oxide", "Other: Placebo"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Sevoflurane 0.2% +/- 30% Nitrous oxide", "interventionNames"=>["Drug: 30% Nitrous oxide", "Drug: 0.2% sevoflurane"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Sevoflurane 0.4% +/- 30% Nitrous oxide", "interventionNames"=>["Drug: 30% Nitrous oxide", "Drug: 0.4% Sevoflurane"]}], "interventions"=>[{"name"=>"30% Nitrous oxide", "type"=>"DRUG", "armGroupLabels"=>["Placebo +/- 30% Nitrous oxide", "Sevoflurane 0.2% +/- 30% Nitrous oxide", "Sevoflurane 0.4% +/- 30% Nitrous oxide"]}, {"name"=>"0.4% Sevoflurane", "type"=>"DRUG", "armGroupLabels"=>["Sevoflurane 0.4% +/- 30% Nitrous oxide"]}, {"name"=>"0.2% sevoflurane", "type"=>"DRUG", "armGroupLabels"=>["Sevoflurane 0.2% +/- 30% Nitrous oxide"]}, {"name"=>"Placebo", "type"=>"OTHER", "armGroupLabels"=>["Placebo +/- 30% Nitrous oxide"]}]}, "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"}}}}