Impact of Cigarette and E-cigarette Menthol Regulation on Current Smokers of Menthol Cigarettes

Recruiting now · Not applicable

Conditions studied: Smoking Prevention and Control

In brief

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.

Key facts

Study ID

NCT05896033

Run by

Medical University of South Carolina

People needed

240

Starts

2023-10-23

Expected to finish

2027-08-31

Last updated by the study team

2026-07-21

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• adults (21+) who a) have been smoking at least 5 cigarettes daily for one year
• usual brand (the brand used most often) is mentholated
• have a smartphone that can receive text messages and access the internet (necessary for diary completion).

You may not qualify if…

• other tobacco and pharmacotherapy criteria
• health and safety criteria
• planning to move out of the area within the next 3 months

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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