Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-29 @ 12:33 AM
Study NCT ID:
NCT00000261
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
1999-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide - 13
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '1998-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '1999-09-20', 'studyFirstSubmitQcDate': '1999-09-20', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '1999-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1998-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mood', 'timeFrame': 'Baseline, inhalation, recovery'}, {'measure': 'Psychomotor performance', 'timeFrame': 'Baseline, inhalation, recovery'}, {'measure': 'Choice of drug vs placebo', 'timeFrame': 'After placebo and drug in each session'}]}, 'conditionsModule': {'keywords': ['nitrous oxide', 'sevoflurane', 'ethanol', 'subjective effects', 'healthy volunteer'], 'conditions': ['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': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Please contact site for information.'}, 'identificationModule': {'nctId': 'NCT00000261', 'briefTitle': 'Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide - 13', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide', 'orgStudyIdInfo': {'id': 'NIDA-08391-13'}, 'secondaryIdInfos': [{'id': 'R01DA008391', 'link': 'https://reporter.nih.gov/quickSearch/R01DA008391', 'type': 'NIH'}, {'id': 'R01-08391-13'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moderate drinking adults', 'interventionNames': ['Drug: 30% Nitrous oxide', 'Other: Placebo', 'Drug: 0.2% sevoflurane', 'Drug: 0.4% sevoflurane', 'Drug: 0.6% sevoflurane']}], 'interventions': [{'name': '30% Nitrous oxide', 'type': 'DRUG', 'armGroupLabels': ['Moderate drinking adults']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'No drug (100% oxygen)', 'armGroupLabels': ['Moderate drinking adults']}, {'name': '0.2% sevoflurane', 'type': 'DRUG', 'armGroupLabels': ['Moderate drinking adults']}, {'name': '0.4% sevoflurane', 'type': 'DRUG', 'armGroupLabels': ['Moderate drinking adults']}, {'name': '0.6% sevoflurane', 'type': 'DRUG', 'armGroupLabels': ['Moderate drinking adults']}]}, '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'}}}}