Nctid:
NCT00000253
Payload:
{"FullStudy"=>{"Rank"=>474140, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"November 27, 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"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Substance Related Disorders", "ConditionBrowseBranchAbbrev"=>"BC25"}, {"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "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"=>"Synovial", "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"=>["Not Applicable"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Non-Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Double", "DesignWhoMaskedList"=>{"DesignWhoMasked"=>["Participant", "Investigator"]}}, "DesignInterventionModel"=>"Crossover Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"16"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"November 1994"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"May 2015", "CompletionDateStruct"=>{"CompletionDate"=>"March 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"=>"March 1996", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Choice of N2O vs. placebo", "PrimaryOutcomeTimeFrame"=>"After each pair of sample tests", "PrimaryOutcomeDescription"=>"Subjects underwent 4 sessions consisting of 2 sample tests (inhaling placebo and inhaling varying doses of N2O), then choosing which inhalant they wanted for a choice test. The subject & the technician administering the inhalant were blinded. During each intervention and each session, subjects underwent psychomotor testing."}]}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["nitrous oxide", "inhalant", "subjective effects", "healthy volunteer"]}, "ConditionList"=>{"Condition"=>["Opioid-Related Disorders", "Substance-Related Disorders"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferenceType"=>"background", "ReferenceCitation"=>"Behavioral Pharmacology, 1996, 7: 194-199."}]}}, "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 subjective, psychomotor, and reinforcing effects of nitrous oxide in healthy volunteers. This is a dose-response analysis."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"37 years", "MinimumAge"=>"21 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"Accepts Healthy Volunteers", "EligibilityCriteria"=>"Please contact site for information."}, "IdentificationModule"=>{"NCTId"=>"NCT00000253", "BriefTitle"=>"Effects of Nitrous Oxide: A Dose-Response Analysis - 5", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"University of Chicago"}, "OfficialTitle"=>"Effects of Nitrous Oxide: A Dose-Response Analysis", "OrgStudyIdInfo"=>{"OrgStudyId"=>"NIDA-08391-5"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01DA008391", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01DA008391", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"R01-08391-5"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"Placebo + 10% N2O", "ArmGroupDescription"=>"0% N2O inhaled during psychomotor testing, 10% N2O inhaled during psycho motor testing, then subject's choice of the 2.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 10% N2O"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"Placebo + 20% N2O", "ArmGroupDescription"=>"Placebo inhaled during psychomotor testing, 20% N2O inhaled during psychomotor testing, then subject's choice of the 2.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 20% N2O"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"Placebo + 30% N2O", "ArmGroupDescription"=>"Placebo inhaled during psychomotor testing, 30% N2O inhaled during psychomotor testing, then subject's choice of the 2.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 30% N2O"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"Placebo + 40% N2O", "ArmGroupDescription"=>"Placebo inhaled during psychomotor testing, 40% N2O inhaled during psychomotor testing, then subject's choice of the 2.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 40% N2O"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"10% N2O", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Placebo + 10% N2O"]}}, {"InterventionName"=>"20% N2O", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Placebo + 20% N2O"]}}, {"InterventionName"=>"30% N2O", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Placebo + 30% N2O"]}}, {"InterventionName"=>"40% N2O", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Placebo + 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"}}}}}}
