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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorMedical University of South Carolina

About this trial

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

Qualifiers

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).

Disqualifiers

other tobacco and pharmacotherapy criteria

health and safety criteria

planning to move out of the area within the next 3 months

Trial design

Treatments tested in this trial

  • Non-Menthol Cigarettes
  • Tobacco Flavored E-cigarettes
  • Menthol Cigarettes
  • Menthol Flavored E-cigarettes

Treatment groups

240 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Medical University of South Carolina

Lead sponsor

National Institutes of Health (NIH)

Collaborator

University of Minnesota

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator