Nctid:
NCT00000263
Payload:
{"FullStudy"=>{"Rank"=>475339, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 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"=>"M14163", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4505", "ConditionBrowseLeafName"=>"Mental 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"=>"D000000431", "InterventionMeshTerm"=>"Ethanol"}, {"InterventionMeshId"=>"D000009609", "InterventionMeshTerm"=>"Nitrous Oxide"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000891", "InterventionAncestorTerm"=>"Anti-Infective Agents, Local"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000002492", "InterventionAncestorTerm"=>"Central Nervous System Depressants"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000018685", "InterventionAncestorTerm"=>"Anesthetics, Inhalation"}, {"InterventionAncestorId"=>"D000018681", "InterventionAncestorTerm"=>"Anesthetics, General"}, {"InterventionAncestorId"=>"D000000777", "InterventionAncestorTerm"=>"Anesthetics"}, {"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"=>"M3467", "InterventionBrowseLeafName"=>"Ethanol", "InterventionBrowseLeafAsFound"=>"Embryo", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M12236", "InterventionBrowseLeafName"=>"Nitrous Oxide", "InterventionBrowseLeafAsFound"=>"Efficiency", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3904", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3905", "InterventionBrowseLeafName"=>"Anti-Infective Agents, Local", "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"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}, {"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", "Care Provider"]}}, "DesignInterventionModel"=>"Crossover Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"11"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"January 1997"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"May 2015", "CompletionDateStruct"=>{"CompletionDate"=>"October 1998", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"May 26, 2015", "StudyFirstSubmitDate"=>"September 20, 1999", "StudyFirstSubmitQCDate"=>"September 20, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"May 27, 2015", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"September 21, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"October 1998", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Pain intensity, pain bothersomeness", "PrimaryOutcomeTimeFrame"=>"Post inhalation"}, {"PrimaryOutcomeMeasure"=>"Mood", "PrimaryOutcomeTimeFrame"=>"Post inhalation"}, {"PrimaryOutcomeMeasure"=>"Psychomotor performance", "PrimaryOutcomeTimeFrame"=>"Post inhalation"}, {"PrimaryOutcomeMeasure"=>"Cognitive performance", "PrimaryOutcomeTimeFrame"=>"Post inhalation"}]}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["nitrous oxide", "ethanol", "drug interaction", "subjective effects", "healthy volunteer"]}, "ConditionList"=>{"Condition"=>["Opioid-Related Disorders", "Substance-Related Disorders"]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to determine the effects of combined alcohol and nitrous oxide intake on mood, psychomotor performance, and the pain response in healthy volunteers."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"Accepts Healthy Volunteers", "EligibilityCriteria"=>"Please contact site for information."}, "IdentificationModule"=>{"NCTId"=>"NCT00000263", "BriefTitle"=>"Effects of Combined Alcohol and Nitrous Oxide Intake - 15", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"University of Chicago"}, "OfficialTitle"=>"Effects of Combined Alcohol and Nitrous Oxide Intake", "OrgStudyIdInfo"=>{"OrgStudyId"=>"NIDA-08391-15"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01DA008391", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01DA008391", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"R01-08391-15"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Placebo Comparator", "ArmGroupLabel"=>"0 g/Kg ethanol +/- 30% nitrous oxide", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 30% Nitrous oxide", "Other: 0 g/Kg ethanol"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"0.25 g/Kg ethanol +/- 30% nitrous oxide", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 30% Nitrous oxide", "Other: 0.25 g/Kg ethanol"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"0.5 g/Kg ethanol +/- 30% nitrous oxide", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 30% Nitrous oxide", "Other: 0.5 g/KG ethanol"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"30% Nitrous oxide", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["0 g/Kg ethanol +/- 30% nitrous oxide", "0.25 g/Kg ethanol +/- 30% nitrous oxide", "0.5 g/Kg ethanol +/- 30% nitrous oxide"]}}, {"InterventionName"=>"0.25 g/Kg ethanol", "InterventionType"=>"Other", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["0.25 g/Kg ethanol +/- 30% nitrous oxide"]}}, {"InterventionName"=>"0.5 g/KG ethanol", "InterventionType"=>"Other", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["0.5 g/Kg ethanol +/- 30% nitrous oxide"]}}, {"InterventionName"=>"0 g/Kg ethanol", "InterventionType"=>"Other", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["0 g/Kg ethanol +/- 30% nitrous oxide"]}}]}}, "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"}}}}}}
