Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2026-02-20 @ 4:47 PM
Study NCT ID:
NCT02740595
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2016-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
E-cigarettes and Blood Vessel Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009538', 'term': 'Nicotine'}], 'ancestors': [{'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-02', 'studyFirstSubmitDate': '2016-04-12', 'studyFirstSubmitQcDate': '2016-04-12', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow mediated dilatation (FMD)', 'timeFrame': '10 minutes after exposure', 'description': 'FMD is a measure of endothelial function'}, {'measure': 'Paraoxonse', 'timeFrame': 'less than 1 hour after exposure', 'description': 'plasma oxidative stress'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nicotine', 'endothelial function', 'oxidative stress'], 'conditions': ['Nicotine Dependence']}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and sham control, on endothelial function and markers of oxidative stress.', 'detailedDescription': 'Participants will use an electronic cigarette on 3 occasions: 1) with nicotine, 2) without nicotine, 3) sham control, and undergo a measure of endothelial function called brachial artery flow mediated dilatation (FMD). Additionally, oxidative stress will be measured pre and post exposure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n\nExclusion Criteria:\n\n* Cardiac disease\n* Respiratory disease\n* Diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT02740595', 'briefTitle': 'E-cigarettes and Blood Vessel Function', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'The Effects of Electronic Cigarettes on Endothelial Function and Oxidative Stress', 'orgStudyIdInfo': {'id': '14-000743'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nicotine', 'description': 'Use an e-cig filled with liquid with nicotine', 'interventionNames': ['Other: one time exposure to e-cig with nicotine']}, {'type': 'EXPERIMENTAL', 'label': 'no nicotine', 'description': 'Use an e-cig filled with liquid without nicotine', 'interventionNames': ['Other: one time exposure to e-cig without nicotine']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham comparator', 'description': 'Use an empty e-cigarette (sham control)', 'interventionNames': ['Other: one time exposure to empty e-cig']}], 'interventions': [{'name': 'one time exposure to e-cig with nicotine', 'type': 'OTHER', 'description': 'one time exposure to e-cig vapor with nicotine', 'armGroupLabels': ['Nicotine']}, {'name': 'one time exposure to e-cig without nicotine', 'type': 'OTHER', 'description': 'one time exposure to e-cig without nicotine', 'armGroupLabels': ['no nicotine']}, {'name': 'one time exposure to empty e-cig', 'type': 'OTHER', 'otherNames': ['sham control'], 'description': 'one time exposure to empty e-cig (sham control', 'armGroupLabels': ['sham comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCaliforniaLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Holly R Middlekauff', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}