Nctid:
NCT00000256
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D019966", "term"=>"Substance-Related Disorders"}, {"id"=>"D009293", "term"=>"Opioid-Related Disorders"}], "ancestors"=>[{"id"=>"D064419", "term"=>"Chemically-Induced Disorders"}, {"id"=>"D001523", "term"=>"Mental Disorders"}, {"id"=>"D000079524", "term"=>"Narcotic-Related Disorders"}], "browseLeaves"=>[{"id"=>"M12244", "name"=>"Opioid-Related Disorders", "asFound"=>"Opioid-Related Disorders", "relevance"=>"HIGH"}, {"id"=>"M21837", "name"=>"Substance-Related Disorders", "asFound"=>"Substance-Related Disorders", "relevance"=>"HIGH"}, {"id"=>"M30302", "name"=>"Chemically-Induced Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M2057", "name"=>"Narcotic-Related Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Substance Related Disorders", "abbrev"=>"BC25"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D009609", "term"=>"Nitrous Oxide"}], "ancestors"=>[{"id"=>"D018685", "term"=>"Anesthetics, Inhalation"}, {"id"=>"D018681", "term"=>"Anesthetics, General"}, {"id"=>"D000777", "term"=>"Anesthetics"}, {"id"=>"D002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D018712", "term"=>"Analgesics, Non-Narcotic"}, {"id"=>"D000700", "term"=>"Analgesics"}, {"id"=>"D018689", "term"=>"Sensory System Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}], "browseLeaves"=>[{"id"=>"M12546", "name"=>"Nitrous Oxide", "asFound"=>"Coronary Artery Bypass Graft", "relevance"=>"HIGH"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M20765", "name"=>"Anesthetics, Inhalation", "relevance"=>"LOW"}, {"id"=>"M20761", "name"=>"Anesthetics, General", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M20786", "name"=>"Analgesics, Non-Narcotic", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"]}, "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>11}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1995-08"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2015-05", "completionDateStruct"=>{"date"=>"1996-11", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2015-05-26", "studyFirstSubmitDate"=>"1999-09-20", "studyFirstSubmitQcDate"=>"1999-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2015-05-28", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-09-21", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1996-11", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Choice of nitrous oxide vs placebo", "timeFrame"=>"After 1.5 min of inhalation each of nitrous oxide then placebo", "description"=>"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."}]}, "conditionsModule"=>{"keywords"=>["nitrous oxide", "reinforcer", "subjective effects", "healthy volunteer"], "conditions"=>["Opioid-Related Disorders", "Substance-Related Disorders"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8912802", "type"=>"BACKGROUND", "citation"=>"Zacny JP, Klafta JM, Coalson DW, Marks S, Young CJ, Klock PA, Toledano AY, Jordan N, Apfelbaum JL. The reinforcing effects of brief exposures to nitrous oxide in healthy volunteers. Drug Alcohol Depend. 1996 Nov;42(3):197-200. doi: 10.1016/s0376-8716(96)01281-1."}]}, "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. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine reinforcing effects of brief exposures to nitrous oxide in healthy volunteers."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"34 years", "minimumAge"=>"22 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Please contact site for information."}, "identificationModule"=>{"nctId"=>"NCT00000256", "briefTitle"=>"Reinforcing Effects of Brief Exposures to Nitrous Oxide - 8", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Chicago"}, "officialTitle"=>"Reinforcing Effects of Brief Exposures to Nitrous Oxide", "orgStudyIdInfo"=>{"id"=>"NIDA-08391-8"}, "secondaryIdInfos"=>[{"id"=>"R01DA008391", "link"=>"https://reporter.nih.gov/quickSearch/R01DA008391", "type"=>"NIH"}, {"id"=>"R01-08391-8"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Placebo + 20% N2O", "description"=>"0% N2O inhaled during psychomotor testing, 20% N2O inhaled during psycho motor testing, then subject's choice of the 2.", "interventionNames"=>["Drug: 20% N2O"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Placebo + 40% N2O", "description"=>"0% N2O inhaled during psychomotor testing, 40% N2O inhaled during psycho motor testing, then subject's choice of the 2.", "interventionNames"=>["Drug: 40% N2O"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Placebo + 60% N2O", "description"=>"0% N2O inhaled during psychomotor testing, 60% N2O inhaled during psycho motor testing, then subject's choice of the 2.", "interventionNames"=>["Drug: 60% N2O"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Placebo + 80% N2O", "description"=>"0% N2O inhaled during psychomotor testing, 80% N2O inhaled during psycho motor testing, then subject's choice of the 2.", "interventionNames"=>["Drug: 80% N2O"]}], "interventions"=>[{"name"=>"20% N2O", "type"=>"DRUG", "armGroupLabels"=>["Placebo + 20% N2O"]}, {"name"=>"40% N2O", "type"=>"DRUG", "armGroupLabels"=>["Placebo + 40% N2O"]}, {"name"=>"60% N2O", "type"=>"DRUG", "armGroupLabels"=>["Placebo + 60% N2O"]}, {"name"=>"80% N2O", "type"=>"DRUG", "armGroupLabels"=>["Placebo + 80% N2O"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"60637", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"University of Chicago, Anesthesia & Critical Care", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}], "overallOfficials"=>[{"name"=>"James Zacny, Ph.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Chicago"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Chicago", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institute on Drug Abuse (NIDA)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}