NCT05896033 Impact of Cigarette and E-cigarette Menthol Regulation on Current Smokers of Menthol Cigarettes
| NCT ID | NCT05896033 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Smoking Prevention and Control |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-10-23 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2023-10-23 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. adults (21+) who a) have been smoking at least 5 cigarettes daily for one year 2. usual brand (the brand used most often) is mentholated 3. have a smartphone that can receive text messages and access the internet (necessary for diary completion). Exclusion Criteria: 1. other tobacco and pharmacotherapy criteria 2. health and safety criteria 3. planning to move out of the area within the next 3 months
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05896033 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Smoking Prevention and Control. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05896033 currently recruiting?
Yes, NCT05896033 is actively recruiting participants. Contact the research team at smithtra@musc.edu for enrollment information.
Where is the NCT05896033 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT05896033 clinical trial?
NCT05896033 is sponsored by Medical University of South Carolina. The trial plans to enroll 240 participants.