Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT05932693
Status:
COMPLETED
Last Update Posted:
2025-08-17
First Post:
2023-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Different E-cigarette Cooling Flavors on Adults' Sensory Experience TCORS 3.0
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-22', 'releaseDate': '2025-12-05'}], 'estimatedResultsFirstSubmitDate': '2025-12-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072137', 'term': 'Vaping'}], 'ancestors': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008610', 'term': 'Menthol'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000081005', 'term': 'Cyclohexane Monoterpenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D039821', 'term': 'Monoterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Participants will be exposed to e-liquids containing 16 conditions (WS-3 block: 0.05%, 0.1%, 0.5%, 1.0%, 2.0%, WS-23 block: 0.05%, 0.1%, 0.5%, 1.0%, 2.0%, 4.0%, and menthol block: 0.05%, 0.1%, 0.5%, 1.0%, 2.0%) from low concentration to high concentration.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants are exposed to all study conditions (16 e-liquid samples).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2023-06-28', 'studyFirstSubmitQcDate': '2023-06-28', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coolness: Score change in coolness of each e-cigarette condition (16 conditions in total)', 'timeFrame': 'Following administration of e-cigarette condition 1 (at 10 minutes), then 5 minutes post administration of each e-cigarette condition, up to 85 minutes (condition 16)', 'description': 'Difference in overall flavor intensity, coolness, sweetness and harshness/irritation at each e-cigarette condition as measured by the computerized Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. The Generalized Labeled Magnitude Scales (gLMS) are category ratio scales with seven semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically as per empirically determined semantic magnitudes on a 0-100 scale (strongest imaginable at the 100 end).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cooling components', 'e-cigarette', 'menthol', 'WS-23', 'WS-3'], 'conditions': ['E-Cig Use']}, 'referencesModule': {'references': [{'pmid': '19833660', 'type': 'BACKGROUND', 'citation': 'Lim J, Wood A, Green BG. Derivation and evaluation of a labeled hedonic scale. Chem Senses. 2009 Nov;34(9):739-51. doi: 10.1093/chemse/bjp054.'}]}, 'descriptionModule': {'briefSummary': 'This pilot sensory experiment will examine cooling from comparable concentrations of WS-3 and menthol to determine appropriate concentrations to use in the main study.', 'detailedDescription': 'This pilot study will establish low and high concentrations of both WS-3 and menthol concentrations to test in the main study. An anticipated 30 adult e-cigarette users will participate in one laboratory session during which participants will be exposed to e-liquids containing five different concentrations of two different cooling flavors without nicotine (10 e-liquids total). Participants will rate "coolness" using the generalized Labeled Magnitude Scale (gLMS). Using averages of participant ratings, we will select a low concentration of each constituent that is rated as more than "barely detectable" but less than "moderate" to ensure that cooling is weak but clearly perceptible. For the high concentration of each constituent, we will select a concentration that on average falls between "strong" and "very strong" to identify a strong cooling sensation while avoiding sensations that would also be uncomfortable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Able to read and write\n* Used e-cigarettes containing nicotine\n* Use e-cigs in past 30 days\n* No strong dislike of the menthol flavor\n* Urine cotinine ≥200ng/ml\n* Willing to abstain from tobacco/nicotine use 2 hrs prior to sessions\n\nExclusion Criteria:\n\n* Known hypersensitivity to propylene glycol\n* Pregnant or lactating females\n* Uncontrolled asthma\n* Nut/e-liquid flavorant allergy\n* Current marijuana (tetrahydrocannabinol) vaping + E-cigarette or vaping use Associated Lung Injury (EVALI) symptoms\n* Dislike of menthol flavor'}, 'identificationModule': {'nctId': 'NCT05932693', 'briefTitle': "Effect of Different E-cigarette Cooling Flavors on Adults' Sensory Experience TCORS 3.0", 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Examine the Effects of Novel E-cigarette Constituents and Determining Appropriate Concentrations Among Adults', 'orgStudyIdInfo': {'id': '2000035551_a'}, 'secondaryIdInfos': [{'id': '2U54DA036151-11', 'link': 'https://reporter.nih.gov/quickSearch/2U54DA036151-11', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WS-3 (1), no nicotine', 'description': 'WS-3 block: 0.05%', 'interventionNames': ['Other: E-liquid coolant (WS-3, 0.05%)']}, {'type': 'EXPERIMENTAL', 'label': 'WS-3 (2), no nicotine', 'description': 'WS-3 block: 0.1%', 'interventionNames': ['Other: E-liquid coolant (WS-3, 0.1%)']}, {'type': 'EXPERIMENTAL', 'label': 'WS-3 (3), no nicotine', 'description': 'WS-3 block: 0.5%', 'interventionNames': ['Other: E-liquid coolant (WS-3, 0.5%)']}, {'type': 'EXPERIMENTAL', 'label': 'WS-3 (4), no nicotine', 'description': 'WS-3 block: 1.0%', 'interventionNames': ['Other: E-liquid coolant (WS-3, 1.0%)']}, {'type': 'EXPERIMENTAL', 'label': 'WS-3 (5), no nicotine', 'description': 'WS-3 block: 2.0%', 'interventionNames': ['Other: E-liquid coolant (WS-3, 2.0%)']}, {'type': 'EXPERIMENTAL', 'label': 'Menthol (1), no nicotine', 'description': 'Menthol block: 0.05%', 'interventionNames': ['Other: E-liquid coolant (menthol, 0.05%)']}, {'type': 'EXPERIMENTAL', 'label': 'Menthol (2), no nicotine', 'description': 'Menthol block: 0.1%', 'interventionNames': ['Other: E-liquid coolant (menthol, 0.1%)']}, {'type': 'EXPERIMENTAL', 'label': 'Menthol (3), no nicotine', 'description': 'Menthol block: 0.5%', 'interventionNames': ['Other: E-liquid coolant (menthol, 0.5%)']}, {'type': 'EXPERIMENTAL', 'label': 'Menthol (4), no nicotine', 'description': 'Menthol block: 1.0%', 'interventionNames': ['Other: E-liquid coolant (menthol, 1.0%)']}, {'type': 'EXPERIMENTAL', 'label': 'Menthol (5), no nicotine', 'description': 'Menthol block: 2.0%', 'interventionNames': ['Other: E-liquid coolant (menthol, 2.0%)']}, {'type': 'EXPERIMENTAL', 'label': 'WS-23 (1), no nicotine', 'description': 'WS-23 block: 0.05%', 'interventionNames': ['Other: E-liquid coolant (WS-23, 0.05%)']}, {'type': 'EXPERIMENTAL', 'label': 'WS-23 (2), no nicotine', 'description': 'WS-23 block: 0.1%', 'interventionNames': ['Other: E-liquid coolant (WS-23, 0.1%)']}, {'type': 'EXPERIMENTAL', 'label': 'WS-23 (3), no nicotine', 'description': 'WS-23 block: 0.5%', 'interventionNames': ['Other: E-liquid coolant (WS-23, 0.5%)']}, {'type': 'EXPERIMENTAL', 'label': 'WS-23 (4), no nicotine', 'description': 'WS-23 block: 1.0%', 'interventionNames': ['Other: E-liquid coolant (WS-23, 1.0%)']}, {'type': 'EXPERIMENTAL', 'label': 'WS-23 (5), no nicotine', 'description': 'WS-23 block: 2.0%', 'interventionNames': ['Other: E-liquid coolant (WS-23, 2.0%)']}, {'type': 'EXPERIMENTAL', 'label': 'WS-23 (6), no nicotine', 'description': 'WS-23 block: 4.0%', 'interventionNames': ['Other: E-liquid coolant (WS-23, 4.0%)']}], 'interventions': [{'name': 'E-liquid coolant (WS-3, 0.05%)', 'type': 'OTHER', 'otherNames': ['Flavor type'], 'description': 'Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.05%.', 'armGroupLabels': ['WS-3 (1), no nicotine']}, {'name': 'E-liquid coolant (WS-3, 0.1%)', 'type': 'OTHER', 'otherNames': ['Flavor type'], 'description': 'Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.1%.', 'armGroupLabels': ['WS-3 (2), no nicotine']}, {'name': 'E-liquid coolant (WS-3, 0.5%)', 'type': 'OTHER', 'otherNames': ['Flavor type'], 'description': 'Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.5%.', 'armGroupLabels': ['WS-3 (3), no nicotine']}, {'name': 'E-liquid coolant (WS-3, 1.0%)', 'type': 'OTHER', 'otherNames': ['Flavor type'], 'description': 'Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 1.0%.', 'armGroupLabels': ['WS-3 (4), no nicotine']}, {'name': 'E-liquid coolant (WS-3, 2.0%)', 'type': 'OTHER', 'otherNames': ['Flavor type'], 'description': 'Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 2.0%.', 'armGroupLabels': ['WS-3 (5), no nicotine']}, {'name': 'E-liquid coolant (menthol, 0.05%)', 'type': 'OTHER', 'otherNames': ['Flavor type'], 'description': 'Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.05%.', 'armGroupLabels': ['Menthol (1), no nicotine']}, {'name': 'E-liquid coolant (menthol, 0.1%)', 'type': 'OTHER', 'otherNames': ['Flavor type'], 'description': 'Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.1%.', 'armGroupLabels': ['Menthol (2), no nicotine']}, {'name': 'E-liquid coolant (menthol, 0.5%)', 'type': 'OTHER', 'otherNames': ['Flavor type'], 'description': 'Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.5%.', 'armGroupLabels': ['Menthol (3), no nicotine']}, {'name': 'E-liquid coolant (menthol, 1.0%)', 'type': 'OTHER', 'otherNames': ['Flavor type'], 'description': 'Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 1.0%.', 'armGroupLabels': ['Menthol (4), no nicotine']}, {'name': 'E-liquid coolant (menthol, 2.0%)', 'type': 'OTHER', 'otherNames': ['Flavor type'], 'description': 'Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 2.0%.', 'armGroupLabels': ['Menthol (5), no nicotine']}, {'name': 'E-liquid coolant (WS-23, 0.05%)', 'type': 'OTHER', 'otherNames': ['Flavor type'], 'description': 'Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.05%.', 'armGroupLabels': ['WS-23 (1), no nicotine']}, {'name': 'E-liquid coolant (WS-23, 0.1%)', 'type': 'OTHER', 'otherNames': ['Flavor type'], 'description': 'Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.1%.', 'armGroupLabels': ['WS-23 (2), no nicotine']}, {'name': 'E-liquid coolant (WS-23, 0.5%)', 'type': 'OTHER', 'otherNames': ['Flavor type'], 'description': 'Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.5%.', 'armGroupLabels': ['WS-23 (3), no nicotine']}, {'name': 'E-liquid coolant (WS-23, 1.0%)', 'type': 'OTHER', 'otherNames': ['Flavor type'], 'description': 'Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 1.0%.', 'armGroupLabels': ['WS-23 (4), no nicotine']}, {'name': 'E-liquid coolant (WS-23, 2.0%)', 'type': 'OTHER', 'otherNames': ['Flavor type'], 'description': 'Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 2.0%.', 'armGroupLabels': ['WS-23 (5), no nicotine']}, {'name': 'E-liquid coolant (WS-23, 4.0%)', 'type': 'OTHER', 'otherNames': ['Flavor type'], 'description': 'Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 4.0%.', 'armGroupLabels': ['WS-23 (6), no nicotine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06473', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Suchitra Krishnan-Sarin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ANALYTIC_CODE'], 'timeFrame': 'The identifiable information will be kept for 7 years. After that, the data will become anonymous.', 'ipdSharing': 'YES', 'description': 'We may share information about the IPD and study results with other researchers in the future, but the information will be de-identified.', 'accessCriteria': 'The de-identified data will be made available for research purposes by contacting the PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-12-05', 'type': 'RELEASE'}, {'date': '2025-12-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Yale University'}}}}