Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
Study NCT ID:
NCT05896033
Status:
RECRUITING
Last Update Posted:
2025-03-05
First Post:
2023-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Cigarette and E-cigarette Menthol Regulation on Current Smokers of Menthol Cigarettes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2023-05-19', 'studyFirstSubmitQcDate': '2023-05-30', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in cigarettes per day', 'timeFrame': 'Week 1- Week 6', 'description': 'Will be measured through week 6 of the study'}], 'secondaryOutcomes': [{'measure': 'Fagerstrom Test for Nicotine Dependence', 'timeFrame': 'Week 1- Week 7', 'description': 'Cigarette Dependence'}, {'measure': 'Ability to abstain from smoking', 'timeFrame': 'Week 7', 'description': 'Participants will complete a 1-week practice quit attempt in week 7; time to first smoking lapse will be assessed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smoking', 'Menthol'], 'conditions': ['Smoking Prevention and Control']}, 'descriptionModule': {'briefSummary': 'In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, the investigators will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, the investigators will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. adults (21+) who a) have been smoking at least 5 cigarettes daily for one year\n2. usual brand (the brand used most often) is mentholated\n3. have a smartphone that can receive text messages and access the internet (necessary for diary completion).\n\nExclusion Criteria:\n\n1. other tobacco and pharmacotherapy criteria\n2. health and safety criteria\n3. planning to move out of the area within the next 3 months'}, 'identificationModule': {'nctId': 'NCT05896033', 'briefTitle': 'Impact of Cigarette and E-cigarette Menthol Regulation on Current Smokers of Menthol Cigarettes', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'The Impact of Menthol Regulation for Cigarettes and E-cigarettes on Tobacco Use Patterns for Current Menthol Smokers', 'orgStudyIdInfo': {'id': '00122898'}, 'secondaryIdInfos': [{'id': '1R01DA055985-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA055985-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Menthol Spectrum Cigarettes and Menthol E-cigarettes', 'description': 'Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.', 'interventionNames': ['Behavioral: Menthol Cigarettes', 'Behavioral: Menthol Flavored E-cigarettes']}, {'type': 'EXPERIMENTAL', 'label': 'Menthol Spectrum Cigarettes and Tobacco E-cigarettes', 'description': 'Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.', 'interventionNames': ['Behavioral: Tobacco Flavored E-cigarettes', 'Behavioral: Menthol Cigarettes']}, {'type': 'EXPERIMENTAL', 'label': 'Non-menthol Spectrum Cigarettes and Menthol E-cigarettes', 'description': 'Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.', 'interventionNames': ['Behavioral: Non-Menthol Cigarettes', 'Behavioral: Menthol Flavored E-cigarettes']}, {'type': 'EXPERIMENTAL', 'label': 'Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes', 'description': 'Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.', 'interventionNames': ['Behavioral: Non-Menthol Cigarettes', 'Behavioral: Tobacco Flavored E-cigarettes']}], 'interventions': [{'name': 'Non-Menthol Cigarettes', 'type': 'BEHAVIORAL', 'description': 'Ppts will be randomly assigned to a group that receives non-menthol cigarettes', 'armGroupLabels': ['Non-menthol Spectrum Cigarettes and Menthol E-cigarettes', 'Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes']}, {'name': 'Tobacco Flavored E-cigarettes', 'type': 'BEHAVIORAL', 'description': 'Ppts will be randomly assigned to a group that receives tobacco flavored e-cigarettes', 'armGroupLabels': ['Menthol Spectrum Cigarettes and Tobacco E-cigarettes', 'Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes']}, {'name': 'Menthol Cigarettes', 'type': 'BEHAVIORAL', 'description': 'Ppts will be randomly assigned to a group that receives menthol flavored cigarettes', 'armGroupLabels': ['Menthol Spectrum Cigarettes and Menthol E-cigarettes', 'Menthol Spectrum Cigarettes and Tobacco E-cigarettes']}, {'name': 'Menthol Flavored E-cigarettes', 'type': 'BEHAVIORAL', 'description': 'Ppts will be randomly assigned to a group that receives menthol flavored e-cigarettes', 'armGroupLabels': ['Menthol Spectrum Cigarettes and Menthol E-cigarettes', 'Non-menthol Spectrum Cigarettes and Menthol E-cigarettes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tracy Smith, PhD', 'role': 'CONTACT', 'email': 'smithtra@musc.edu', 'phone': '8437925164'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'centralContacts': [{'name': 'Tracy T Smith', 'role': 'CONTACT', 'email': 'smithtra@musc.edu', 'phone': '8437925164'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'University of Minnesota', 'class': 'OTHER'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor-Faculty', 'investigatorFullName': 'Tracy Smith', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}