The Impact of Menthol Regulation for Cigarettes and E-cigarettes on Tobacco Use Patterns for Current Menthol Smokers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Changes in cigarettes per day
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Menthol Spectrum Cigarettes and Menthol E-cigarettes
Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
Intervention: Menthol Flavored E-cigarettes (Behavioral)
Menthol Spectrum Cigarettes and Menthol E-cigarettes
Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
Intervention: Menthol Cigarettes (Behavioral)
Menthol Spectrum Cigarettes and Tobacco E-cigarettes
Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
Intervention: Tobacco Flavored E-cigarettes (Behavioral)
Menthol Spectrum Cigarettes and Tobacco E-cigarettes
Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
Intervention: Menthol Cigarettes (Behavioral)
Non-menthol Spectrum Cigarettes and Menthol E-cigarettes
Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
Intervention: Non-Menthol Cigarettes (Behavioral)
Non-menthol Spectrum Cigarettes and Menthol E-cigarettes
Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
Intervention: Menthol Flavored E-cigarettes (Behavioral)
Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes
Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
Intervention: Non-Menthol Cigarettes (Behavioral)
Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes
Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
Intervention: Tobacco Flavored E-cigarettes (Behavioral)
Outcomes
Primary Outcomes
Changes in cigarettes per day
Time Frame: Week 1- Week 6
Will be measured through week 6 of the study
Secondary Outcomes
- Fagerstrom Test for Nicotine Dependence(Week 1- Week 7)
- Ability to abstain from smoking(Week 7)
Investigators
Tracy Smith
Associate Professor-Faculty
Medical University of South Carolina