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

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of Menthol Regulation for Cigarettes and E-cigarettes on Tobacco Use Patterns for Current Menthol Smokers

Conditions
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Smoking Prevention and Control

Intervention / Treatment
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* Behavioral: Non-Menthol Cigarettes
* Behavioral: Tobacco Flavored E-cigarettes
* Behavioral: Menthol Cigarettes
* Behavioral: Menthol Flavored E-cigarettes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Menthol Spectrum Cigarettes and Menthol E-cigarettes<br>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. | Behavioral: Menthol Cigarettes<br>* Ppts will be randomly assigned to a group that receives menthol flavored cigarettes<br>Behavioral: Menthol Flavored E-cigarettes<br>* Ppts will be randomly assigned to a group that receives menthol flavored e-cigarettes<br>|
| Experimental: Menthol Spectrum Cigarettes and Tobacco E-cigarettes<br>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. | Behavioral: Tobacco Flavored E-cigarettes<br>* Ppts will be randomly assigned to a group that receives tobacco flavored e-cigarettes<br>Behavioral: Menthol Cigarettes<br>* Ppts will be randomly assigned to a group that receives menthol flavored cigarettes<br>|
| Experimental: Non-menthol Spectrum Cigarettes and Menthol E-cigarettes<br>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. | Behavioral: Non-Menthol Cigarettes<br>* Ppts will be randomly assigned to a group that receives non-menthol cigarettes<br>Behavioral: Menthol Flavored E-cigarettes<br>* Ppts will be randomly assigned to a group that receives menthol flavored e-cigarettes<br>|
| Experimental: Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes<br>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. | Behavioral: Non-Menthol Cigarettes<br>* Ppts will be randomly assigned to a group that receives non-menthol cigarettes<br>Behavioral: Tobacco Flavored E-cigarettes<br>* Ppts will be randomly assigned to a group that receives tobacco flavored e-cigarettes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cigarettes per day | Will be measured through week 6 of the study | Week 1- Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fagerstrom Test for Nicotine Dependence | Cigarette Dependence | Week 1- Week 7 | 
| Ability to abstain from smoking | Participants will complete a 1-week practice quit attempt in week 7; time to first smoking lapse will be assessed. | Week 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Menthol