Nctid:
NCT00000259
Payload:
{"FullStudy"=>{"Rank"=>474629, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 01, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000019966", "ConditionMeshTerm"=>"Substance-Related Disorders"}, {"ConditionMeshId"=>"D000009293", "ConditionMeshTerm"=>"Opioid-Related Disorders"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000064419", "ConditionAncestorTerm"=>"Chemically-Induced Disorders"}, {"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}, {"ConditionAncestorId"=>"D000079524", "ConditionAncestorTerm"=>"Narcotic-Related Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M26827", "ConditionBrowseLeafName"=>"Respiratory Aspiration", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11934", "ConditionBrowseLeafName"=>"Opioid-Related Disorders", "ConditionBrowseLeafAsFound"=>"Opioid-Related Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M21527", "ConditionBrowseLeafName"=>"Substance-Related Disorders", "ConditionBrowseLeafAsFound"=>"Substance-Related Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M29992", "ConditionBrowseLeafName"=>"Chemically-Induced Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4505", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14163", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2057", "ConditionBrowseLeafName"=>"Narcotic-Related Disorders", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Respiratory Tract (Lung and Bronchial) Diseases", "ConditionBrowseBranchAbbrev"=>"BC08"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Substance Related Disorders", "ConditionBrowseBranchAbbrev"=>"BC25"}, {"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000009609", "InterventionMeshTerm"=>"Nitrous Oxide"}, {"InterventionMeshId"=>"D000077149", "InterventionMeshTerm"=>"Sevoflurane"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000010975", "InterventionAncestorTerm"=>"Platelet Aggregation Inhibitors"}, {"InterventionAncestorId"=>"D000018685", "InterventionAncestorTerm"=>"Anesthetics, Inhalation"}, {"InterventionAncestorId"=>"D000018681", "InterventionAncestorTerm"=>"Anesthetics, General"}, {"InterventionAncestorId"=>"D000000777", "InterventionAncestorTerm"=>"Anesthetics"}, {"InterventionAncestorId"=>"D000002492", "InterventionAncestorTerm"=>"Central Nervous System Depressants"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000018712", "InterventionAncestorTerm"=>"Analgesics, Non-Narcotic"}, {"InterventionAncestorId"=>"D000000700", "InterventionAncestorTerm"=>"Analgesics"}, {"InterventionAncestorId"=>"D000018689", "InterventionAncestorTerm"=>"Sensory System Agents"}, {"InterventionAncestorId"=>"D000018373", "InterventionAncestorTerm"=>"Peripheral Nervous System Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M1673", "InterventionBrowseLeafName"=>"Sevoflurane", "InterventionBrowseLeafAsFound"=>"Group 2", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M12236", "InterventionBrowseLeafName"=>"Nitrous Oxide", "InterventionBrowseLeafAsFound"=>"Involve", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M13555", "InterventionBrowseLeafName"=>"Platelet Aggregation Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3797", "InterventionBrowseLeafName"=>"Anesthetics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20455", "InterventionBrowseLeafName"=>"Anesthetics, Inhalation", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20451", "InterventionBrowseLeafName"=>"Anesthetics, General", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3722", "InterventionBrowseLeafName"=>"Analgesics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20476", "InterventionBrowseLeafName"=>"Analgesics, Non-Narcotic", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}, {"InterventionBrowseBranchName"=>"Platelet Aggregation Inhibitors", "InterventionBrowseBranchAbbrev"=>"PlAggInh"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Analgesics", "InterventionBrowseBranchAbbrev"=>"Analg"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Not Applicable"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Non-Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Double", "DesignWhoMaskedList"=>{"DesignWhoMasked"=>["Participant", "Investigator"]}}, "DesignInterventionModel"=>"Crossover Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"12"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"August 1996"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"May 2015", "CompletionDateStruct"=>{"CompletionDate"=>"November 1997", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"May 26, 2015", "StudyFirstSubmitDate"=>"September 20, 1999", "StudyFirstSubmitQCDate"=>"September 20, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"May 28, 2015", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"September 21, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"November 1997", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Pain intensity", "PrimaryOutcomeTimeFrame"=>"30 min of inhalation", "PrimaryOutcomeDescription"=>"Subjects underwent a 3 min cold immersion test at 30 min of inhalation and then provided response to pain intensity questionnaire"}, {"PrimaryOutcomeMeasure"=>"Psychomotor performance", "PrimaryOutcomeTimeFrame"=>"Baseline, 5 min of inhalation; 5, 30, 60 minutes recovery", "PrimaryOutcomeDescription"=>"Subjects underwent psychomotor testing at baseline, during inhalation, and during recovery post inhalation"}, {"PrimaryOutcomeMeasure"=>"Cognitive performance", "PrimaryOutcomeTimeFrame"=>"Baseline, every 5 min during inhalation, 5, 30, & 60 min during recovery", "PrimaryOutcomeDescription"=>"Subject underwent memory, sedation, visual analog, and drug effects testing"}]}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["sevoflurane", "nitrous oxide", "subjective effects", "healthy volunteer"]}, "ConditionList"=>{"Condition"=>["Opioid-Related Disorders", "Substance-Related Disorders"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferenceType"=>"background", "ReferenceCitation"=>"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"=>{"Gender"=>"All", "MaximumAge"=>"39 years", "MinimumAge"=>"21 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"Accepts Healthy Volunteers", "EligibilityCriteria"=>"Please contact site for information."}, "IdentificationModule"=>{"NCTId"=>"NCT00000259", "BriefTitle"=>"Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations - 11", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"University of Chicago"}, "OfficialTitle"=>"Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations", "OrgStudyIdInfo"=>{"OrgStudyId"=>"NIDA-08391-11"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01DA008391", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01DA008391", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"R01-08391-11"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Placebo Comparator", "ArmGroupLabel"=>"Placebo", "ArmGroupDescription"=>"Subject inhales no drug (100% oxygen)", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Other: Placebo"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"0.3% sevoflurane", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 0.3 % Sevoflurane"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"0.6% sevoflurane", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 0.6% Sevoflurane"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"15% Nitrous oxide", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 15 % Nitrous oxide"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"30% Nitrous oxide", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 30% Nitrous oxide"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"15 % Nitrous oxide", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["15% Nitrous oxide"]}}, {"InterventionName"=>"0.3 % Sevoflurane", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["0.3% sevoflurane"]}}, {"InterventionName"=>"30% Nitrous oxide", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["30% Nitrous oxide"]}}, {"InterventionName"=>"0.6% Sevoflurane", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["0.6% sevoflurane"]}}, {"InterventionName"=>"Placebo", "InterventionType"=>"Other", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Placebo"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"60637", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"University of Chicago, Anesthesia & Critical Care"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"James Zacny, Ph.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"University of Chicago"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"University of Chicago", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute on Drug Abuse (NIDA)", "CollaboratorClass"=>"NIH"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
