Smoking Prevention and Control
Conditions
Keywords
Smoking, Menthol
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.
Interventions
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
Sponsors
Study design
Eligibility
Inclusion criteria
1. adults (21+) who a) have been smoking at least 5 cigarettes daily for one year 2. usual brand (the brand used most often) is mentholated 3. have a smartphone that can receive text messages and access the internet (necessary for diary completion).
Exclusion criteria
1. other tobacco and pharmacotherapy criteria 2. health and safety criteria 3. planning to move out of the area within the next 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in cigarettes per day | Week 1- Week 6 | Will be measured through week 6 of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fagerstrom Test for Nicotine Dependence | Week 1- Week 7 | Cigarette Dependence |
| Ability to abstain from smoking | Week 7 | Participants will complete a 1-week practice quit attempt in week 7; time to first smoking lapse will be assessed. |
Countries
United States