Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
Study NCT ID:
NCT04009850
Status:
TERMINATED
Last Update Posted:
2024-03-08
First Post:
2019-07-03
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064424', 'term': 'Tobacco Use'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'krysten.bold@yale.edu', 'phone': '203-974-7603', 'title': 'Dr. Krysten Bold', 'organization': 'Yale School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for the 10 weeks of study participation.', 'description': 'No participants were enrolled in the tobacco e-cigarette condition.', 'eventGroups': [{'id': 'EG000', 'title': 'Menthol E-cigarette', 'description': 'Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette\n\nCigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tobacco E-cigarette', 'description': 'Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette\n\nE-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Number of Cigarettes Smoked', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menthol E-cigarette', 'description': 'Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette\n\nCigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes'}, {'id': 'OG001', 'title': 'Tobacco E-cigarette', 'description': 'Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette\n\nE-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'spread': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6', 'description': 'Self-reported total number of cigarettes smoked per day (Timeline Follow Back)', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were enrolled in the tobacco e-cigarette condition.'}, {'type': 'SECONDARY', 'title': 'E-cigarette Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menthol E-cigarette', 'description': 'Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette\n\nCigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes'}, {'id': 'OG001', 'title': 'Tobacco E-cigarette', 'description': 'Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette\n\nE-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes'}], 'timeFrame': 'Week 6', 'description': 'Self-reported e-cigarette use compared by e-cigarette flavor (Timeline Follow Back)', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were not conducted for this outcome examining use by e-cigarette flavor condition because no participants were enrolled in the tobacco e-cigarette condition.'}, {'type': 'SECONDARY', 'title': 'Tobacco Product Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menthol E-cigarette', 'description': 'Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette\n\nCigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes'}, {'id': 'OG001', 'title': 'Tobacco E-cigarette', 'description': 'Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette\n\nE-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '1.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6', 'description': 'Self-reported subjective ratings of satisfaction with tobacco products (Modified Cigarette/E-cigarette Evaluation Questionnaire), rated 1-7 with higher scores indicating greater satisfaction', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were enrolled in the tobacco e-cigarette condition.'}, {'type': 'SECONDARY', 'title': 'Motivation to Quit Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menthol E-cigarette', 'description': 'Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette\n\nCigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes'}, {'id': 'OG001', 'title': 'Tobacco E-cigarette', 'description': 'Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette\n\nE-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '2.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6', 'description': 'Self-reported motivation to quit smoking cigarettes (Contemplation Ladder), rated 1-10, higher scores indicate greater motivation to quit', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were enrolled in the tobacco e-cigarette condition.'}, {'type': 'SECONDARY', 'title': 'Nicotine Dependence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menthol E-cigarette', 'description': 'Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette\n\nCigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes'}, {'id': 'OG001', 'title': 'Tobacco E-cigarette', 'description': 'Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette\n\nE-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6', 'description': 'Self-reported nicotine dependence (NIH Promis Dependence Measure), rated 1-5, higher scores indicate greater dependence', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were enrolled in the tobacco e-cigarette condition.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Menthol E-cigarette', 'description': 'Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette\n\nCigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes'}, {'id': 'FG001', 'title': 'Tobacco E-cigarette', 'description': 'Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette\n\nE-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Menthol E-cigarette', 'description': 'Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette\n\nCigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes'}, {'id': 'BG001', 'title': 'Tobacco E-cigarette', 'description': 'Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette\n\nE-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'spread': '13.6', 'groupId': 'BG000'}, {'value': '43.3', 'spread': '13.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'No participants were enrolled in the tobacco e-cigarette condition prior to study termination.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-16', 'size': 425297, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-02-09T15:14', 'hasProtocol': True}, {'date': '2021-03-19', 'size': 263194, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-13T16:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Within-subject design comparing smoking behavior when using menthol vs. non-menthol cigarettes with either menthol or tobacco flavored e-cigarettes'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Study enrollment was temporarily paused in 2020 due to COVID-19. Study was closed without further enrollment in 2022.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2019-07-03', 'resultsFirstSubmitDate': '2022-02-10', 'studyFirstSubmitQcDate': '2019-07-03', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-25', 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Number of Cigarettes Smoked', 'timeFrame': 'Week 6', 'description': 'Self-reported total number of cigarettes smoked per day (Timeline Follow Back)'}], 'secondaryOutcomes': [{'measure': 'E-cigarette Use', 'timeFrame': 'Week 6', 'description': 'Self-reported e-cigarette use compared by e-cigarette flavor (Timeline Follow Back)'}, {'measure': 'Tobacco Product Satisfaction', 'timeFrame': 'Week 6', 'description': 'Self-reported subjective ratings of satisfaction with tobacco products (Modified Cigarette/E-cigarette Evaluation Questionnaire), rated 1-7 with higher scores indicating greater satisfaction'}, {'measure': 'Motivation to Quit Smoking', 'timeFrame': 'Week 6', 'description': 'Self-reported motivation to quit smoking cigarettes (Contemplation Ladder), rated 1-10, higher scores indicate greater motivation to quit'}, {'measure': 'Nicotine Dependence', 'timeFrame': 'Week 6', 'description': 'Self-reported nicotine dependence (NIH Promis Dependence Measure), rated 1-5, higher scores indicate greater dependence'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Use']}, 'descriptionModule': {'briefSummary': 'This study will investigate within-person changes in smoking behavior when current menthol smokers are switched to non-menthol cigarettes and either tobacco or menthol flavored e-cigarettes.', 'detailedDescription': 'The goals of this project include evaluating within-subject changes in cigarette satisfaction and smoking behavior after switching from menthol cigarettes and investigating whether outcomes differ between subjects based on use of menthol vs. tobacco flavored e-cigarettes. Within-person changes in cigarette satisfaction and smoking behavior will be assessed during the last week of the non-menthol cigarette smoking period compared to the menthol cigarette smoking period. Preference and use of both the cigarette and e-cigarette products during the switching period will be compared and the extent to which menthol flavored (vs. tobacco) e-cigarettes are preferred among menthol smokers will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 or older\n* Able to read English\n* Cigarette smoker\n\nExclusion Criteria:\n\n* Seeking smoking cessation treatment\n* Serious psychiatric or medical condition\n* Use of other drugs\n* Unable or unwilling to complete study protocol'}, 'identificationModule': {'nctId': 'NCT04009850', 'briefTitle': 'Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior', 'orgStudyIdInfo': {'id': '2000025572'}, 'secondaryIdInfos': [{'id': '2U54DA036151-06', 'link': 'https://reporter.nih.gov/quickSearch/2U54DA036151-06', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Menthol e-cigarette', 'description': 'Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette', 'interventionNames': ['Other: Cigarette Brand Switching']}, {'type': 'EXPERIMENTAL', 'label': 'Tobacco e-cigarette', 'description': 'Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette', 'interventionNames': ['Other: E-cigarette Flavor']}], 'interventions': [{'name': 'Cigarette Brand Switching', 'type': 'OTHER', 'description': 'Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes', 'armGroupLabels': ['Menthol e-cigarette']}, {'name': 'E-cigarette Flavor', 'type': 'OTHER', 'description': 'Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes', 'armGroupLabels': ['Tobacco e-cigarette']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Krysten Bold, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'Food and Drug Administration (FDA)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}