Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
Study NCT ID:
NCT06868368
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2025-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perceptions of Vaping Products
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'}], 'ancestors': [{'id': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomization to condition order will be completed prior to study Visit 1. Each participant will receive a randomized ordering developed using a random sequence generator.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-01-14', 'studyFirstSubmitQcDate': '2025-03-06', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of metatine and nicotine e-cigarettes', 'timeFrame': 'Pre-vaping session, Minute 5 of vaping session, Minute 15 of vaping session, Minute 30 of vaping session', 'description': 'Pharmacokinetics of metatine and nicotine e-cigarettes will be examined by measuring the concentration of metatine and nicotine in blood plasma at different timepoints throughout the study vaping session.'}, {'measure': 'E-cigarette puffing behavior', 'timeFrame': 'Week 1, Week 2, Week 3', 'description': 'E-cigarette puffing behavior will be measured with a topography device that records frequency, duration, and flow rate of e-cigarette puffs. These measures are combined to inform the overall measure of e-cigarette puffing behavior.'}, {'measure': 'Sensory perceptions of EC vaping experience', 'timeFrame': 'Minute 5 of vaping session, Minute 30 of vaping session', 'description': 'Sensory perceptions of vaping will be measured by the Sensory E-cigarette Expectancies Scale (SEES) questionnaire. The SEES asks questions about sensory experiences associated with vaping on a scale from 0 (Never) - 4 (Almost Always).'}, {'measure': 'Appeal ratings', 'timeFrame': 'Minute 5 of vaping session, Minute 30 of vaping session', 'description': 'Participants will rate appeal (e.g., liking, disliking) on Visual Analogue Scales (range, 0-100).'}, {'measure': 'Sensory ratings', 'timeFrame': 'Minute 5 of vaping session, Minute 30 of vaping session', 'description': 'Participants will rate sensory attributes (e.g., harshness, coolness) on Visual Analogue Scales (range, 0-100).'}, {'measure': 'Relief of withdrawal symptoms', 'timeFrame': 'Pre-vaping session, Minute 5 of Vaping Session, Minute 30 of vaping session', 'description': 'Nicotine withdrawal relief will be measured by the Minnesota Nicotine Withdraw Scale (MNWS). The MNWS asks users how much they are currently feeling certain nicotine withdraw symptoms on a scale of None, Slight, Moderate, Mild, or Severe.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Abuse Tobacco', 'Exposure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial studies the effects, appeal, and abuse liability of 6-methyl nicotine (metatine) electronic cigarettes among young adults.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Assess the pharmacokinetics of metatine and nicotine electronic (e)-cigarettes.\n\nII. Assess the abuse liability and appeal of commercial e-cigarettes containing metatine versus nicotine.\n\nIII. Determine the impact of metatine on e-cigarette puffing behavior (topography).\n\nOUTLINE: Participants attend 3 sessions where they will be randomized to 1 of 3 types of e-cigarette. Participants will use the e-cigarette ad-libitum for 30 minutes and answer survey questions about their perceptions of the e-cigarette. Participants must also undergo 4 blood draws during the vaping session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '34 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 21-34 years\n* Current nicotine EC user (defined as ≥ weekly use over the past 3 months)\n* Willing to provide informed consent and abstain from using any e-cigarette at least 12 hours prior to the three lab sessions\n* Read and speak English\n\nExclusion Criteria:\n\n* Recently coronavirus disease 2019 (COVID-19) positive (defined as a positive test in the past 30 days) or a recent COVID-19 hospitalization (defined as a hospitalization within the past 6 months)\n* Unstable or significant psychiatric conditions (past and stable conditions will be allowed)\n* History of cardiac event or distress within the past 3 months\n* Have suffered from any serious lung disease or infection (e.g., tuberculosis, cystic fibrosis, or lung cancer) in the past 30 days\n* Are currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test)\n* Have hemophilia or another type of bleeding disorder\n* Are blind, severely visually impaired, deaf, hard of hearing, or have a severe motor disability'}, 'identificationModule': {'nctId': 'NCT06868368', 'briefTitle': 'Perceptions of Vaping Products', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'Perceptions of Vaping Products Among Young Adults', 'orgStudyIdInfo': {'id': 'OSU-24276'}, 'secondaryIdInfos': [{'id': 'NCI-2024-10267', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': "Participant's personal nicotine e-cigarette", 'description': "The study participant's own preferred e-cigarette will be used for this condition.", 'interventionNames': ['Other: Biospecimen Collection', 'Other: Survey Administration', 'Behavioral: Vaping Topography', "Other: Participant's Own Preferred E-cigarette"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nicotine e-cigarette', 'description': 'A fruit flavored commercially available nicotine e-cigarette will be used for this condition.', 'interventionNames': ['Other: Biospecimen Collection', 'Other: Survey Administration', 'Behavioral: Vaping Topography', 'Other: Nicotine E-cigarette']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6-methyl nicotine (metatine) e-cigarette', 'description': 'A fruit flavored commercially available metatine e-cigarette will be used for this condition.', 'interventionNames': ['Other: Biospecimen Collection', 'Other: Survey Administration', 'Behavioral: Vaping Topography', 'Other: 6-methyl-nicotine (metatine) e-cigarette']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'OTHER', 'otherNames': ['Biological Sample Collection'], 'description': 'Undergo blood sample collection', 'armGroupLabels': ['6-methyl nicotine (metatine) e-cigarette', 'Nicotine e-cigarette', "Participant's personal nicotine e-cigarette"]}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Complete Surveys', 'armGroupLabels': ['6-methyl nicotine (metatine) e-cigarette', 'Nicotine e-cigarette', "Participant's personal nicotine e-cigarette"]}, {'name': 'Vaping Topography', 'type': 'BEHAVIORAL', 'description': 'Use e-cigarette connected to a topography device', 'armGroupLabels': ['6-methyl nicotine (metatine) e-cigarette', 'Nicotine e-cigarette', "Participant's personal nicotine e-cigarette"]}, {'name': "Participant's Own Preferred E-cigarette", 'type': 'OTHER', 'description': 'Participant vapes their own preferred e-cigarette for 30 minutes', 'armGroupLabels': ["Participant's personal nicotine e-cigarette"]}, {'name': 'Nicotine E-cigarette', 'type': 'OTHER', 'description': 'Participant vapes a commercially available nicotine e-cigarette for 30 minutes', 'armGroupLabels': ['Nicotine e-cigarette']}, {'name': '6-methyl-nicotine (metatine) e-cigarette', 'type': 'OTHER', 'description': 'Participant vapes a commercially available metatine e-cigarette for 30 minutes', 'armGroupLabels': ['6-methyl nicotine (metatine) e-cigarette']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Alayna P Tackett, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alayna Tackett', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}