Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-30 @ 4:55 PM
Study NCT ID:
NCT03209661
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2017-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascular Effects of a Single Bout of Electronic Cigarette Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D066300', 'term': 'Electronic Nicotine Delivery Systems'}], 'ancestors': [{'id': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'E-cigarettes being utilized are of the same brand and design. Additionally, the device will be covered by a sheath to ensure labeling is not visible to the subject.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Subjects will be asked to inhale one of three mediums; 5.4% NBV e-ciggarette, 0% NBV cigarette, and sham menthol inhaler (no vapor). Baseline measurements will be conducted upon arrival and followed immediately post inhalation, 1-hour post, and finally 2-hours post. All trials will require a minimum of 48 hours washout.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2017-06-30', 'studyFirstSubmitQcDate': '2017-07-05', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in arterial stiffness and endothelial function with e-cigarette use.', 'timeFrame': 'Immediately Post, 1 hour, and 2 hour.', 'description': 'Arterial stiffness and endothelial function are two of the subclinical markers of vascular dysfunction'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vascular function'], 'conditions': ['Arterial Stiffness']}, 'referencesModule': {'references': [{'pmid': '31531991', 'type': 'DERIVED', 'citation': 'Cossio R, Cerra ZA, Tanaka H. Vascular effects of a single bout of electronic cigarette use. Clin Exp Pharmacol Physiol. 2020 Jan;47(1):3-6. doi: 10.1111/1440-1681.13180. Epub 2019 Oct 7.'}]}, 'descriptionModule': {'briefSummary': 'Investigating the acute effects of a single use E-Cigarette upon vascular health.', 'detailedDescription': 'Subjects will inhale e-cigarettes of 5.4%, 0%, and sham menthol inhaler to determine the effects upon to measures of vascular health. These measures will include Cardio-Ankle Vascular Index and Flow Mediated Dilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apparently healthy, with no cardiovascular or metabolic diseases. Additionally, is not a frequent smoker of any kind.\n\nExclusion Criteria:\n\n* Cardiovascular or Metabolic Diseases and/or regular smoker.'}, 'identificationModule': {'nctId': 'NCT03209661', 'briefTitle': 'Vascular Effects of a Single Bout of Electronic Cigarette Use', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Vascular Effects of a Single Bout of Electronic Cigarette Use', 'orgStudyIdInfo': {'id': '2016-04-0115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'E-Cigarette 5.4% NBV', 'description': 'Subjects will be asked to inhale an E-Cigarette with 5.4% NBV for 6 min.', 'interventionNames': ['Drug: E-cigarette']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'E-Cigarette 0% NBV', 'description': 'Subjects will be asked to inhale an E-Cigarette with 0% NBV for 6 min.', 'interventionNames': ['Drug: Nicotine 0%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Menthol Inhaler', 'description': 'Subjects will be asked to inhale a sham methole inhaler (that looks identical in looks to E-cigarette) for 6 minutes. This arm is to control for a potential effect of menthole.', 'interventionNames': ['Drug: Menthol Inhalant Product']}], 'interventions': [{'name': 'E-cigarette', 'type': 'DRUG', 'otherNames': ['Nicotine 5.4%'], 'description': 'E-Cigarette containing 5.4% nicotine will be administered to determine the effects on vascular function.', 'armGroupLabels': ['E-Cigarette 5.4% NBV']}, {'name': 'Nicotine 0%', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'E-Cigarette containing 0% nicotine will be administered to determine the effects on vascular function.', 'armGroupLabels': ['E-Cigarette 0% NBV']}, {'name': 'Menthol Inhalant Product', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Menthol inhaler will be administered to determine the effects on vascular function.', 'armGroupLabels': ['Menthol Inhaler']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Cardiovascular Aging Research Lab at UT Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Hirofumi Tanaka, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}