Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-27 @ 1:09 AM
Study NCT ID:
NCT00000257
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
1999-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Alcohol History on Effects of Nitrous Oxide - 9
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '1997-04', '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': '1997-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Choice of nitrous oxide vs placebo', 'timeFrame': 'After 30 min inhalation each of N2O and placebo', 'description': 'Two subject groups (light drinkers vs moderate drinkers) were asked to inhale a given conc of N2O and inhale a placebo, then choose for a third inhalation. The subject \\& the technician administering the inhalant were blinded. Testing was done at each dose.'}]}, 'conditionsModule': {'keywords': ['nitrous oxide', 'subjective effects', 'ethanol', 'healthy volunteer'], 'conditions': ['Alcohol-Related Disorders', 'Opioid-Related Disorders', 'Substance-Related Disorders']}, 'referencesModule': {'references': [{'pmid': '9179508', 'type': 'BACKGROUND', 'citation': 'Cho AM, Coalson DW, Klock PA, Klafta JM, Marks S, Toledano AY, Apfelbaum JL, Zacny JP. The effects of alcohol history on the reinforcing, subjective and psychomotor effects of nitrous oxide in healthy volunteers. Drug Alcohol Depend. 1997 Apr 14;45(1-2):63-70. doi: 10.1016/s0376-8716(97)01346-x.'}]}, '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 determine effects of alcohol history on the reinforcing, subjective and psychomotor effects of nitrous oxide in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Please contact site for information.'}, 'identificationModule': {'nctId': 'NCT00000257', 'briefTitle': 'Effects of Alcohol History on Effects of Nitrous Oxide - 9', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Effects of Alcohol History on Effects of Nitrous Oxide', 'orgStudyIdInfo': {'id': 'NIDA-08391-9'}, 'secondaryIdInfos': [{'id': 'R01DA008391', 'link': 'https://reporter.nih.gov/quickSearch/R01DA008391', 'type': 'NIH'}, {'id': 'R01-08391-9'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Light drinkers', 'interventionNames': ['Drug: 0% N2O and 10% N2O', 'Drug: 0% N2O and 20% N2O', 'Drug: 0% N2O and 30% N2O', 'Drug: 0% N2O and 40% N2O']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moderate drinkers', 'interventionNames': ['Drug: 0% N2O and 10% N2O', 'Drug: 0% N2O and 20% N2O', 'Drug: 0% N2O and 30% N2O', 'Drug: 0% N2O and 40% N2O']}], 'interventions': [{'name': '0% N2O and 10% N2O', 'type': 'DRUG', 'armGroupLabels': ['Light drinkers', 'Moderate drinkers']}, {'name': '0% N2O and 20% N2O', 'type': 'DRUG', 'armGroupLabels': ['Light drinkers', 'Moderate drinkers']}, {'name': '0% N2O and 30% N2O', 'type': 'DRUG', 'armGroupLabels': ['Light drinkers', 'Moderate drinkers']}, {'name': '0% N2O and 40% N2O', 'type': 'DRUG', 'armGroupLabels': ['Light drinkers', 'Moderate drinkers']}]}, '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'}}}}