Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-30 @ 11:18 AM
Study NCT ID:
NCT01616004
Status:
UNKNOWN
Last Update Posted:
2014-09-23
First Post:
2012-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acute Treatment With N2O on Inhibitory Pain Mechanisms in Healthy Subject
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009609', 'term': 'Nitrous Oxide'}, {'id': 'D000388', 'term': 'Air'}], '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': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-21', 'studyFirstSubmitDate': '2012-06-03', 'studyFirstSubmitQcDate': '2012-06-08', 'lastUpdatePostDateStruct': {'date': '2014-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Scores on the Visual Analog Scale', 'timeFrame': 'August 2016'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether N2O (laughing gas) has an antinociceptive effects in healthy volunteers.', 'detailedDescription': "10 healthy volunteers will come twice to the pain medicine unit, at 1 visit they'll get N2O and in the second visit they'll get air as placebo, they won't know what they're getting. During the visit they'll get heat stimulus using QST and will have to report their pain using eVAS (scale from 0 to 100 when 0 is no pain and 100 is the worst pain imagine)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-50 years old\n* women and men\n* healthy\n\nExclusion Criteria:\n\n* smokers\n* medication use pregnant woman cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT01616004', 'acronym': 'N2O', 'briefTitle': 'Effect of Acute Treatment With N2O on Inhibitory Pain Mechanisms in Healthy Subject', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Effect of Acute Treatment With N2O on Inhibitory Pain Mechanisms in Healthy Subject', 'orgStudyIdInfo': {'id': 'TASMC-12-SB-340-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'N2O', 'description': 'N20 70% inhalation 5 minutes O2 100 % inhalation for 5 minutes', 'interventionNames': ['Drug: N2O']}, {'type': 'SHAM_COMPARATOR', 'label': 'Air', 'interventionNames': ['Drug: Air']}], 'interventions': [{'name': 'N2O', 'type': 'DRUG', 'otherNames': ['laughing gas'], 'armGroupLabels': ['N2O']}, {'name': 'Air', 'type': 'DRUG', 'description': 'sham comparator', 'armGroupLabels': ['Air']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'contacts': [{'name': 'silviu Brill, M.D', 'role': 'CONTACT', 'email': 'silviub@tasmc.health.gov.il', 'phone': '972-3-6974477'}], 'facility': 'Tel Aviv Sourasky Medical Center, Pain Medicine Unit', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Silviu Brill, M.D', 'role': 'CONTACT', 'email': 'silviub@tasmc.health.gov.il', 'phone': '972-3-6974477'}], 'overallOfficials': [{'name': 'Silviu Brill, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel-Aviv Sourasky Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}