Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-28 @ 10:31 PM
Study NCT ID:
NCT04568395
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2020-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of TCIG vs ECIG in PLWH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072137', 'term': 'Vaping'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'single (outcomes assessor) code'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Crossover with 1 week washout'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-02', 'studyFirstSubmitDate': '2020-09-18', 'studyFirstSubmitQcDate': '2020-09-23', 'lastUpdatePostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tpe', 'timeFrame': 'Change in Tpe 5 minutes after cigarette use', 'description': 'interval indicative of ventricular repolarization measured on ECG'}, {'measure': 'Tpe/QT', 'timeFrame': 'Change in Tpe/QT after cigarette use', 'description': 'interval indicative of ventricular repolarization measured on ECG'}, {'measure': 'Tpe/QTc', 'timeFrame': 'Change in Tpe/QTc after cigarette use', 'description': 'interval indicative of ventricular repolarization measured on ECG'}, {'measure': 'Total Cellular Reactive Oxygen Stress', 'timeFrame': 'within 4 hours of cigarette use', 'description': 'total cellular oxidative stress measured by flow cytometry'}], 'secondaryOutcomes': [{'measure': 'QT', 'timeFrame': 'Change in QT after cigarette use', 'description': 'interval indicative of ventricular repolarization measured on ECG'}, {'measure': 'QTc', 'timeFrame': 'Change in QTc after cigarette use', 'description': 'interval indicative of ventricular repolarization measured on ECG'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['E Cigarette Use', 'Vaping', 'Smoking', 'Tobacco Smoking', 'Nicotine Use Disorder', 'Qt Interval, Variation in', 'HIV I Infection', 'Oxidative Stress', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization and inflammation/oxidative stress.', 'detailedDescription': 'On separate days, participants will undergo 3 different exposures: an acute e-cigarette exposure, an acute tobacco cigarette exposure, and a sham (empty e-cigarette) control . Before and after the acute exposure, participants will have blood drawn for inflammation/oxidative stress markers and undergo a 5-minute ECG recording.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChronic (\\> 1year) TCIG smoker HIV positive Stable ART Viral count non-detectable CD4 \\>500\n\nExclusion Criteria:\n\nKnown major illness (heart disease, diabetes, lung or liver disease) Daily recreational drug use, including cannabis \\>2 alcoholic drinks per day Obesity (\\>30 kg/m2) Recent (\\<3 months) infection'}, 'identificationModule': {'nctId': 'NCT04568395', 'briefTitle': 'Acute Effects of TCIG vs ECIG in PLWH', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Acute Impact of Switching From Tobacco Cigarettes to E-Cigarettes in People Living With HIV', 'orgStudyIdInfo': {'id': '20-001179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PLWH smoker', 'description': 'PLWH who smoke will undergo 3 interventions : acute TCIG use, acute ECIG use and acute sham control', 'interventionNames': ['Other: TCIG', 'Other: ECIG', 'Other: sham control']}], 'interventions': [{'name': 'TCIG', 'type': 'OTHER', 'description': 'Use a TCIG', 'armGroupLabels': ['PLWH smoker']}, {'name': 'ECIG', 'type': 'OTHER', 'description': 'Use an ECIG', 'armGroupLabels': ['PLWH smoker']}, {'name': 'sham control', 'type': 'OTHER', 'description': 'Use a sham control (empty ECIG)', 'armGroupLabels': ['PLWH smoker']}]}, 'contactsLocationsModule': {'locations': [{'zip': '890095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'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'}, 'collaborators': [{'name': 'Tobacco Related Disease Research Program', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Holly R Middlekauff', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}