Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 9:05 PM
Study NCT ID:
NCT00000259
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
1999-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations - 11
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009609', 'term': 'Nitrous Oxide'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '1997-11', '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': '1997-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '30 min of inhalation', 'description': 'Subjects underwent a 3 min cold immersion test at 30 min of inhalation and then provided response to pain intensity questionnaire'}, {'measure': 'Psychomotor performance', 'timeFrame': 'Baseline, 5 min of inhalation; 5, 30, 60 minutes recovery', 'description': 'Subjects underwent psychomotor testing at baseline, during inhalation, and during recovery post inhalation'}, {'measure': 'Cognitive performance', 'timeFrame': 'Baseline, every 5 min during inhalation, 5, 30, & 60 min during recovery', 'description': 'Subject underwent memory, sedation, visual analog, and drug effects testing'}]}, 'conditionsModule': {'keywords': ['sevoflurane', 'nitrous oxide', 'subjective effects', 'healthy volunteer'], 'conditions': ['Opioid-Related Disorders', 'Substance-Related Disorders']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Anesthesiology. 1997 (in press).'}]}, '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 sevoflurane versus isoflurane inhalation at subanesthetic concentrations on mood, pain, and psychomotor performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Please contact site for information.'}, 'identificationModule': {'nctId': 'NCT00000259', 'briefTitle': 'Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations - 11', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations', 'orgStudyIdInfo': {'id': 'NIDA-08391-11'}, 'secondaryIdInfos': [{'id': 'R01DA008391', 'link': 'https://reporter.nih.gov/quickSearch/R01DA008391', 'type': 'NIH'}, {'id': 'R01-08391-11'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subject inhales no drug (100% oxygen)', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.3% sevoflurane', 'interventionNames': ['Drug: 0.3 % Sevoflurane']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.6% sevoflurane', 'interventionNames': ['Drug: 0.6% Sevoflurane']}, {'type': 'ACTIVE_COMPARATOR', 'label': '15% Nitrous oxide', 'interventionNames': ['Drug: 15 % Nitrous oxide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '30% Nitrous oxide', 'interventionNames': ['Drug: 30% Nitrous oxide']}], 'interventions': [{'name': '15 % Nitrous oxide', 'type': 'DRUG', 'armGroupLabels': ['15% Nitrous oxide']}, {'name': '0.3 % Sevoflurane', 'type': 'DRUG', 'armGroupLabels': ['0.3% sevoflurane']}, {'name': '30% Nitrous oxide', 'type': 'DRUG', 'armGroupLabels': ['30% Nitrous oxide']}, {'name': '0.6% Sevoflurane', 'type': 'DRUG', 'armGroupLabels': ['0.6% sevoflurane']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, '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'}}}}