Nctid:
NCT00000252
Payload:
{"FullStudy"=>{"Rank"=>474636, "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"=>"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"}, {"ConditionBrowseLeafId"=>"T170", "ConditionBrowseLeafName"=>"Acute Graft Versus Host Disease", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Substance Related Disorders", "ConditionBrowseBranchAbbrev"=>"BC25"}, {"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000009609", "InterventionMeshTerm"=>"Nitrous Oxide"}]}, "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"}, {"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"=>"M12236", "InterventionBrowseLeafName"=>"Nitrous Oxide", "InterventionBrowseLeafAsFound"=>"Activity tracker", "InterventionBrowseLeafRelevance"=>"high"}, {"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"=>"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"=>"Double", "DesignWhoMaskedList"=>{"DesignWhoMasked"=>["Participant", "Investigator"]}}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Crossover Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"11"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"June 1994"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"May 2015", "CompletionDateStruct"=>{"CompletionDate"=>"June 1996", "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"=>"June 1996", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Psychomotor performance", "PrimaryOutcomeTimeFrame"=>"During inhalation", "PrimaryOutcomeDescription"=>"Subjects will undergo psychomotor testing during 120 min inhalation session of each intervention"}, {"PrimaryOutcomeMeasure"=>"Cognitive performance", "PrimaryOutcomeTimeFrame"=>"During inhalation", "PrimaryOutcomeDescription"=>"Subjects will under cognitive testing during 120 minute inhalation session of each intervention"}]}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["nitrous oxide", "acute tolerance", "subjective effects", "psychomotor", "analgesia", "healthy volunteer"]}, "ConditionList"=>{"Condition"=>["Opioid-Related Disorders", "Substance-Related Disorders"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"8743615", "ReferenceType"=>"background", "ReferenceCitation"=>"Yajnik S, Zacny JP, Young CJ, Lichtor JL, Rupani G, Klafta JM, Coalson DW, Apfelbaum JL. Lack of acute tolerance development to the subjective, cognitive, and psychomotor effects of nitrous oxide in healthy volunteers. Pharmacol Biochem Behav. 1996 Jun;54(2):501-8. doi: 10.1016/0091-3057(95)02278-3."}]}}, "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 examine the lack of acute tolerance development to the subjective, cognitive, and psychomotor effects of nitrous oxide in healthy volunteers."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"29 years", "MinimumAge"=>"21 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"Accepts Healthy Volunteers", "EligibilityCriteria"=>"Please contact site for information."}, "IdentificationModule"=>{"NCTId"=>"NCT00000252", "BriefTitle"=>"Lack of Acute Tolerance Development to Effects of Nitrous Oxide - 4", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"University of Chicago"}, "OfficialTitle"=>"Lack of Acute Tolerance Development to Effects of Nitrous Oxide", "OrgStudyIdInfo"=>{"OrgStudyId"=>"NIDA-08391-4"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01DA008391", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01DA008391", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"R01-08391-4"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Sham Comparator", "ArmGroupLabel"=>"0% N2O", "ArmGroupDescription"=>"Subjects will inhale 0% N2O", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 0% N2O"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"10% N2O", "ArmGroupDescription"=>"Subjects will inhale 10% N2O", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 10% N2O"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"20% N2O", "ArmGroupDescription"=>"Subjects will inhale 20% N2O", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 20% N2O"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"30% N2O", "ArmGroupDescription"=>"Subjects will inhale 30% N2O", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 30% N2O"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"40% N2O", "ArmGroupDescription"=>"Subjects will inhale 40% N2O", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 40% N2O"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"0% N2O", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["0% N2O"]}}, {"InterventionName"=>"10% N2O", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["10% N2O"]}}, {"InterventionName"=>"20% N2O", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["20% N2O"]}}, {"InterventionName"=>"30% N2O", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["30% N2O"]}}, {"InterventionName"=>"40% N2O", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["40% N2O"]}}]}}, "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"}}}}}}
