Nctid:
NCT00000259
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"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"]}, "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>12}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1996-08"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2015-05", "completionDateStruct"=>{"date"=>"1997-11", "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"=>"1997-11", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Pain intensity", "timeFrame"=>"30 min of inhalation", "description"=>"Subjects underwent a 3 min cold immersion test at 30 min of inhalation and then provided response to pain intensity questionnaire"}, {"measure"=>"Psychomotor performance", "timeFrame"=>"Baseline, 5 min of inhalation; 5, 30, 60 minutes recovery", "description"=>"Subjects underwent psychomotor testing at baseline, during inhalation, and during recovery post inhalation"}, {"measure"=>"Cognitive performance", "timeFrame"=>"Baseline, every 5 min during inhalation, 5, 30, & 60 min during recovery", "description"=>"Subject underwent memory, sedation, visual analog, and drug effects testing"}]}, "conditionsModule"=>{"keywords"=>["sevoflurane", "nitrous oxide", "subjective effects", "healthy volunteer"], "conditions"=>["Opioid-Related Disorders", "Substance-Related Disorders"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Anesthesiology. 1997 (in press)."}]}, "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. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine sevoflurane versus isoflurane inhalation at subanesthetic concentrations on mood, pain, and psychomotor performance."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"39 years", "minimumAge"=>"21 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Please contact site for information."}, "identificationModule"=>{"nctId"=>"NCT00000259", "briefTitle"=>"Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations - 11", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Chicago"}, "officialTitle"=>"Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations", "orgStudyIdInfo"=>{"id"=>"NIDA-08391-11"}, "secondaryIdInfos"=>[{"id"=>"R01DA008391", "link"=>"https://reporter.nih.gov/quickSearch/R01DA008391", "type"=>"NIH"}, {"id"=>"R01-08391-11"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo", "description"=>"Subject inhales no drug (100% oxygen)", "interventionNames"=>["Other: Placebo"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"0.3% sevoflurane", "interventionNames"=>["Drug: 0.3 % Sevoflurane"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"0.6% sevoflurane", "interventionNames"=>["Drug: 0.6% Sevoflurane"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"15% Nitrous oxide", "interventionNames"=>["Drug: 15 % Nitrous oxide"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"30% Nitrous oxide", "interventionNames"=>["Drug: 30% Nitrous oxide"]}], "interventions"=>[{"name"=>"15 % Nitrous oxide", "type"=>"DRUG", "armGroupLabels"=>["15% Nitrous oxide"]}, {"name"=>"0.3 % Sevoflurane", "type"=>"DRUG", "armGroupLabels"=>["0.3% sevoflurane"]}, {"name"=>"30% Nitrous oxide", "type"=>"DRUG", "armGroupLabels"=>["30% Nitrous oxide"]}, {"name"=>"0.6% Sevoflurane", "type"=>"DRUG", "armGroupLabels"=>["0.6% sevoflurane"]}, {"name"=>"Placebo", "type"=>"OTHER", "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"}}}}