Nctid:
NCT00000261
Payload:
{"FullStudy"=>{"Rank"=>474132, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"November 27, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000019966", "ConditionMeshTerm"=>"Substance-Related Disorders"}, {"ConditionMeshId"=>"D000009293", "ConditionMeshTerm"=>"Opioid-Related Disorders"}, {"ConditionMeshId"=>"D000019973", "ConditionMeshTerm"=>"Alcohol-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"=>"M21532", "ConditionBrowseLeafName"=>"Alcohol-Related Disorders", "ConditionBrowseLeafAsFound"=>"Alcohol-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"}, {"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"=>"M3467", "InterventionBrowseLeafName"=>"Ethanol", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M1673", "InterventionBrowseLeafName"=>"Sevoflurane", "InterventionBrowseLeafAsFound"=>"Recombinant", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M12236", "InterventionBrowseLeafName"=>"Nitrous Oxide", "InterventionBrowseLeafAsFound"=>"Chemo-", "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"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Platelet Aggregation Inhibitors", "InterventionBrowseBranchAbbrev"=>"PlAggInh"}, {"InterventionBrowseBranchName"=>"Analgesics", "InterventionBrowseBranchAbbrev"=>"Analg"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"N/A", "DesignMaskingInfo"=>{"DesignMasking"=>"Double", "DesignWhoMaskedList"=>{"DesignWhoMasked"=>["Participant", "Care Provider"]}}, "DesignInterventionModel"=>"Single Group Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"14"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"November 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"=>"Mood", "PrimaryOutcomeTimeFrame"=>"Baseline, inhalation, recovery"}, {"PrimaryOutcomeMeasure"=>"Psychomotor performance", "PrimaryOutcomeTimeFrame"=>"Baseline, inhalation, recovery"}, {"PrimaryOutcomeMeasure"=>"Choice of drug vs placebo", "PrimaryOutcomeTimeFrame"=>"After placebo and drug in each session"}]}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["nitrous oxide", "sevoflurane", "ethanol", "subjective effects", "healthy volunteer"]}, "ConditionList"=>{"Condition"=>["Alcohol-Related Disorders", "Opioid-Related Disorders", "Substance-Related Disorders"]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to evaluate the effects of alcohol history on the subjective and reinforcing effects of sevoflurane and nitrous oxide in healthy volunteers. All subjects underwent psychomotor testing during 4 sessions of placebo, drug/placebo, and choice of intervention."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Please contact site for information."}, "IdentificationModule"=>{"NCTId"=>"NCT00000261", "BriefTitle"=>"Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide - 13", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"University of Chicago"}, "OfficialTitle"=>"Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide", "OrgStudyIdInfo"=>{"OrgStudyId"=>"NIDA-08391-13"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01DA008391", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01DA008391", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"R01-08391-13"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"Moderate drinking adults", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: 30% Nitrous oxide", "Other: Placebo", "Drug: 0.2% sevoflurane", "Drug: 0.4% sevoflurane", "Drug: 0.6% sevoflurane"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"30% Nitrous oxide", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Moderate drinking adults"]}}, {"InterventionName"=>"Placebo", "InterventionType"=>"Other", "InterventionDescription"=>"No drug (100% oxygen)", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Moderate drinking adults"]}}, {"InterventionName"=>"0.2% sevoflurane", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Moderate drinking adults"]}}, {"InterventionName"=>"0.4% sevoflurane", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Moderate drinking adults"]}}, {"InterventionName"=>"0.6% sevoflurane", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Moderate drinking adults"]}}]}}, "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"}}}}}}