Actively Recruiting
Impact of Cigarette and E-cigarette Menthol Regulation on Current Smokers of Menthol Cigarettes
Led by Medical University of South Carolina · Updated on 2026-03-05
240
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Cigarette and E-cigarette Menthol Regulation on Current Smokers of Menthol Cigarettes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 21 years or older who have smoked at least 5 cigarettes daily for one year
- Usual cigarette brand is mentholated
- Own a smartphone capable of receiving text messages and accessing the internet for diary completion
You will not qualify if you...
- Use of other tobacco products or pharmacotherapy that conflicts with the study
- Health or safety concerns preventing participation
- Planning to move out of the area within the next 3 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
T
Tracy T Smith
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
4
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