Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-03-05 @ 6:04 PM
Study NCT ID:
NCT03072628
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2017-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
E-cigarettes, Nicotine Inhaler, 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': 'D066300', 'term': 'Electronic Nicotine Delivery Systems'}, {'id': 'D009538', 'term': 'Nicotine'}], 'ancestors': [{'id': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'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': '2017-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-02', 'studyFirstSubmitDate': '2017-03-02', 'studyFirstSubmitQcDate': '2017-03-02', 'lastUpdatePostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, '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': 'Heart rate variability (HRV)', 'timeFrame': '10 minutes after exposure', 'description': 'HRV is a measure of cardiac sympathetic tone'}], 'secondaryOutcomes': [{'measure': 'Paraoxonase (PON)', 'timeFrame': '~30 minutes after exposure', 'description': 'PON is a measure of oxidative stress'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nicotine', 'sympathetic nerve activity', 'oxidative stress'], 'conditions': ['Nicotine Dependence']}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, nicotine inhaler, and sham-control on endothelial function, oxidative stress and sympathetic nerve activity', 'detailedDescription': 'Participants will have an acute exposure on 4 occasions1) e-cigarette with nicotine, 2) e-cigarette without nicotine, 3) nicotine inhaler, 4) sham control and undergo ECG recording for heart rate variability, endothelial function measurement using ultrasound ("FMD") and blood tests for oxidative stress markers.'}, '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': 'NCT03072628', 'briefTitle': 'E-cigarettes, Nicotine Inhaler, 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-AM-00008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nicotine: use e-cig with nicotine', 'description': 'One time exposure to e-cig with nicotine', 'interventionNames': ['Other: e-cig with nicotine']}, {'type': 'EXPERIMENTAL', 'label': 'no nicotine: use e-cig without nicotine', 'description': 'One time exposure to e-cig without nicotine', 'interventionNames': ['Other: e-cig without nicotine']}, {'type': 'EXPERIMENTAL', 'label': 'Nicotine inhaler: use a nictoine inhaler', 'description': 'One time exposure to nicotine inhaler', 'interventionNames': ['Other: nicotine inhaler']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham control', 'description': 'Use an empty e-cigarette', 'interventionNames': ['Other: sham control']}], 'interventions': [{'name': 'e-cig with nicotine', 'type': 'OTHER', 'description': 'use an e-cig with nicotine for 30 minutes', 'armGroupLabels': ['Nicotine: use e-cig with nicotine']}, {'name': 'e-cig without nicotine', 'type': 'OTHER', 'description': 'use an e-cig without nicotine for 30 minutes', 'armGroupLabels': ['no nicotine: use e-cig without nicotine']}, {'name': 'nicotine inhaler', 'type': 'OTHER', 'description': 'use a nicotine inhaler for 30 minutes', 'armGroupLabels': ['Nicotine inhaler: use a nictoine inhaler']}, {'name': 'sham control', 'type': 'OTHER', 'description': 'use an empty e-cigarette for 30 minutes', 'armGroupLabels': ['Sham control']}]}, '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'}}}}