Impact of Cigarette and E-cigarette Menthol Regulation on Current Smokers of Menthol Cigarettes
Medical University of South Carolina · with National Institutes of Health (NIH), University of Minnesota · NCT05896033
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 21+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 240
- US sites recruiting
- 1
- Study start
- October 23, 2023
- Record last updated
- July 21, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: Non-Menthol Cigarettes; Tobacco Flavored E-cigarettes; Menthol Cigarettes; Menthol Flavored E-cigarettes
Conditions: Smoking Prevention and Control
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- other tobacco and pharmacotherapy criteria
- health and safety criteria
- planning to move out of the area within the next 3 months
Recruiting US locations
Medical University of South Carolina
Charleston, SC 29425
Site contact: Tracy Smith, PhD · 843-792-5164 · smithtra@musc.edu
Study contacts (from the official record)
- Tracy T Smith · 8437925164 · smithtra@musc.edu
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