Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Location status: Recruiting
NCT Number: NCT05896033
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.
Interested in participating?
Request Info21 year and older
All sexes
Interventional
Not applicable
Charleston, South Carolina, 29425, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ppts will be randomly assigned to a group that receives non-menthol cigarettes
Ppts will be randomly assigned to a group that receives tobacco flavored e-cigarettes
Ppts will be randomly assigned to a group that receives menthol flavored cigarettes
Ppts will be randomly assigned to a group that receives menthol flavored e-cigarettes
Time frame: Week 1- Week 6
Will be measured through week 6 of the study
Time frame: Week 1- Week 7
Cigarette Dependence
Time frame: Week 7
Participants will complete a 1-week practice quit attempt in week 7; time to first smoking lapse will be assessed.
Contact information is provided by the study sponsor or research team.
Medical University of South Carolina
Other
The Impact of Menthol Regulation for Cigarettes and E-cigarettes on Tobacco Use Patterns for Current Menthol Smokers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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