Nctid:
NCT00000251
Payload:
{"FullStudy"=>{"Rank"=>499069, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "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"=>"M21837", "ConditionBrowseLeafName"=>"Substance-Related Disorders", "ConditionBrowseLeafAsFound"=>"Substance-Related Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M12244", "ConditionBrowseLeafName"=>"Opioid-Related Disorders", "ConditionBrowseLeafAsFound"=>"Opioid-Related Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M30302", "ConditionBrowseLeafName"=>"Chemically-Induced Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4815", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14473", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2057", "ConditionBrowseLeafName"=>"Narcotic-Related Disorders", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Substance Related Disorders", "ConditionBrowseBranchAbbrev"=>"BC25"}, {"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000007530", "InterventionMeshTerm"=>"Isoflurane"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"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"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M12546", "InterventionBrowseLeafName"=>"Nitrous Oxide", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M10562", "InterventionBrowseLeafName"=>"Isoflurane", "InterventionBrowseLeafAsFound"=>"Placing", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M4107", "InterventionBrowseLeafName"=>"Anesthetics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20765", "InterventionBrowseLeafName"=>"Anesthetics, Inhalation", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20761", "InterventionBrowseLeafName"=>"Anesthetics, General", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Analgesics", "InterventionBrowseBranchAbbrev"=>"Analg"}, {"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Single", "DesignWhoMaskedList"=>{"DesignWhoMasked"=>["Participant"]}}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Crossover Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"10"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"April 1994"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"November 2015", "CompletionDateStruct"=>{"CompletionDate"=>"January 1996", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"November 30, 2015", "StudyFirstSubmitDate"=>"September 20, 1999", "StudyFirstSubmitQCDate"=>"September 20, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"December 2, 2015", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"September 21, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"January 1996", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Logical reasoning test", "PrimaryOutcomeTimeFrame"=>"15 & 30 min inhalation and 5, 30, & 60 min post inhalation"}, {"PrimaryOutcomeMeasure"=>"Free recall memory test", "PrimaryOutcomeTimeFrame"=>"15 & 30 min inhalation and 5, 30, & 60 min post inhalation"}, {"PrimaryOutcomeMeasure"=>"Auditory reaction time", "PrimaryOutcomeTimeFrame"=>"15 & 30 min inhalation and 5,30 & 60 min post inhalation"}, {"PrimaryOutcomeMeasure"=>"Digit symbol substitution test", "PrimaryOutcomeTimeFrame"=>"2,15 & 30 min inhalation and 5,30 & 60 min post inhalation"}]}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["nitrous oxide", "isoflurane", "subjective effects", "psychomotor", "healthy volunteer", "drug interaction"]}, "ConditionList"=>{"Condition"=>["Opioid-Related Disorders", "Substance-Related Disorders"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"8712393", "ReferenceType"=>"background", "ReferenceCitation"=>"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."}, {"ReferencePMID"=>"29610659", "ReferenceType"=>"derived", "ReferenceCitation"=>"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"=>{"Gender"=>"All", "MaximumAge"=>"32 years", "MinimumAge"=>"21 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"Accepts Healthy Volunteers", "EligibilityCriteria"=>"Please contact site for information."}, "IdentificationModule"=>{"NCTId"=>"NCT00000251", "BriefTitle"=>"Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"University of Chicago"}, "OfficialTitle"=>"Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide", "OrgStudyIdInfo"=>{"OrgStudyId"=>"NIDA-08391-3"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01DA008391", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01DA008391", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"R01-08391-3"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Placebo Comparator", "ArmGroupLabel"=>"Placebo", "ArmGroupDescription"=>"Subjects inhale 100% oxygen", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Other: 100% oxygen"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"30% N2O", "ArmGroupDescription"=>"Subjects inhale 30% N2O", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 30% N2O"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"0.2% isoflurane", "ArmGroupDescription"=>"Subjects inhale 0.2% isoflurane", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 0.2% isoflurane"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"0.4% isoflurane", "ArmGroupDescription"=>"Subjects inhale 0.4% isoflurane", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 0.4% isoflurane"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"0.2% isoflurane + 30% N2O", "ArmGroupDescription"=>"Subjects will inhale a combination of 0.2% isoflurane and 30% N2O", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 30% N2O", "Drug: 0.2% isoflurane"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"0.4% isoflurane + 30% N2O", "ArmGroupDescription"=>"Subjects will inhale a combination of 0.4% isoflurane and 30% N2O", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 30% N2O", "Drug: 0.4% isoflurane"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"30% N2O", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["0.2% isoflurane + 30% N2O", "0.4% isoflurane + 30% N2O", "30% N2O"]}}, {"InterventionName"=>"0.2% isoflurane", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["0.2% isoflurane", "0.2% isoflurane + 30% N2O"]}}, {"InterventionName"=>"0.4% isoflurane", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["0.4% isoflurane", "0.4% isoflurane + 30% N2O"]}}, {"InterventionName"=>"100% oxygen", "InterventionType"=>"Other", "InterventionDescription"=>"Placebo", "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"}}}}}}