Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT05869318
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-17
First Post:
2023-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Respiratory Effects of E-Cigarettes in Obese Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072137', 'term': 'Vaping'}], 'ancestors': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-12', 'size': 320929, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-10-15T13:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2023-05-11', 'studyFirstSubmitQcDate': '2023-05-19', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced expiratory volume in 1 second', 'timeFrame': 'Change from 0 to 35 minutes', 'description': 'Spirometry will be completed before and after a 35 min vaping session'}, {'measure': 'Functional residual capacity', 'timeFrame': 'Change from 0 to 35 minutes', 'description': 'Plethymosgraphy will be completed before and after a 35 min vaping session'}, {'measure': 'Diffusion capacity', 'timeFrame': 'Change from 0 to 35 minutes', 'description': 'DLCO will be completed before and after a 35 min vaping session'}, {'measure': 'Airway resistance', 'timeFrame': 'Change from 0 to 35 minutes', 'description': 'Plethymosgraphy to measure airway resistance (Raw) will be completed before and after a 35 min vaping session'}, {'measure': 'Puff count', 'timeFrame': '35 minutes', 'description': 'E-cig puff topography data collection for abuse liability'}, {'measure': 'Average Puff duration', 'timeFrame': '35 minutes', 'description': 'E-cig puff topography data collection for abuse liability'}, {'measure': 'Average Puff volume', 'timeFrame': '35 minutes', 'description': 'E-cig puff topography data collection for abuse liability'}], 'secondaryOutcomes': [{'measure': 'Tiffany-Drobes Questionnaire of Smoking Urges', 'timeFrame': 'Change from 0 to 35 minutes', 'description': 'Assess E-cig craving/suppression of craving'}, {'measure': 'Respiratory health questionnaire', 'timeFrame': 'Change from 0 to 35 minutes', 'description': 'Assess respiratory symptoms'}, {'measure': 'Exhaled carbon monoxide', 'timeFrame': 'Change from 0 to 35 minutes', 'description': 'Assess carbon monoxide in exhaled air'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['E-Cig Use']}, 'descriptionModule': {'briefSummary': 'To determine vaping behaviors and respiratory function in obese and nonobese youth e-cigarette users.', 'detailedDescription': 'The investigators hypothesize that obese youth e-cigarette users will have increased e-cigarette use that will worsen respiratory function. The approach will involve a clinical trial where vaping behaviors (using puff topography) and respiratory function (spirometry, plethysmography, and diffusion capacity) will be assessed while participants vape with their own e-cigarette and, on a separate visit, with the VUSE e-cigarette.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a current e-cigarette user (≥1 vaping bout daily) for at least the past 3 months,\n* 21-25 years old,\n* willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions,\n* willing to complete five lab visits lasting up to 4 hours each,\n* able to read and speak English,\n* willing to provide informed consent.\n\nExclusion Criteria:\n\n* self-reported diagnosis of lung disease including asthma or cystic fibrosis\n* history of cardiac event or distress within the past 3 months\n* history of metabolic disease including thyroid disease or diabetes\n* history of orthopedic or neuromuscular problems that preclude exercise\n* currently pregnant (determined using urine pregnancy test), planning to become pregnant, delivered a child in the past 6 weeks even if not breastfeeding, or currently breastfeeding\n* use of other tobacco products \\>10 days in the past month\n* current marijuana use \\>10 times per month\n* currently engaging in a vaping cessation attempt\n* ) competitive athlete or individual currently engaged in an exercise training program involving 420min or more (moderate intensity aerobic activity) or 210 min or more (vigorous intensity aerobic activity) per week with the goal of participating in a competitive event or marathon, triathlon, etc. Participants who are engaged in usual physical activity (e.g., walking dog, biking to work, etc.) but not engaged in a "structured exercise training program" will not be excluded.\n* plans to leave the Columbus or central Ohio region within the next year.'}, 'identificationModule': {'nctId': 'NCT05869318', 'acronym': 'RESEC', 'briefTitle': 'Respiratory Effects of E-Cigarettes in Obese Youth', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'RESEC: Respiratory Effects of E-Cigarettes in Obese Youth', 'orgStudyIdInfo': {'id': 'OSU-22219'}, 'secondaryIdInfos': [{'id': 'NCI-2023-04458', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaping', 'description': 'All participants will undergo two vaping sessions: one using their own device and one using the study device', 'interventionNames': ['Other: ECIG own', 'Other: ECIG Vuse']}], 'interventions': [{'name': 'ECIG own', 'type': 'OTHER', 'description': 'Participants will vape using their own ecig device', 'armGroupLabels': ['Vaping']}, {'name': 'ECIG Vuse', 'type': 'OTHER', 'description': 'Participants will vape a VUSE e-cigarette (GOLD 5%)', 'armGroupLabels': ['Vaping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Dharini M Bhammar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dharini Bhammar', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}