Potential Impact of Menthol Ban in Cigarettes and E-cigarettes

Study Overview
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Brief Summary
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Menthol cigarette use remains a major public health problem and the FDA has proposed to ban menthol in cigarettes. However, additional evidence is needed to understand whether menthol flavor in e-cigarettes is important for harm reduction among menthol cigarette smokers in the context of a menthol cigarette ban. The primary aim of this project is to understand how the availability of menthol vs tobacco flavor e-cigarettes influences switching and reduces smoking behavior among adults who currently smoke menthol cigarettes to understand the potential effects in the context of a ban of menthol cigarettes.

Detailed Description
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Menthol cigarette use remains a major public health problem and the FDA has proposed to ban menthol in cigarettes. However, additional evidence is needed to understand whether menthol flavor in e-cigarettes is important for harm reduction among menthol cigarette smokers in the context of a menthol cigarette ban. The primary aim of this project is to understand how the availability of menthol vs tobacco flavor e-cigarettes influences switching and reduces smoking behavior among adults who currently smoke menthol cigarettes to understand the potential effects in the context of a ban of menthol cigarettes. The secondary aim of this project is to understand whether smoking behavior outcomes differ by race to understand the impact of these potential menthol ban policies on addressing tobacco-related health disparities. This single site study will take place over a 4 year study period; approximately 14 weeks for each participant's completion. 150 adults who currently smoke menthol cigarettes will be enrolled and prospectively randomized using a randomization ratio of 1:1:1 to 1 of 3 groups (N=50 per group). Following an initial baseline period where participants have access to their usual menthol cigarettes (Phase I), participants will receive tobacco products to use for 8 weeks based on their assigned group modeling 3 possible regulatory scenarios (Phase II): 1) no menthol ban (menthol cigarettes and e-cigarettes available), 2) menthol ban in cigarettes only (non-menthol cigarettes and menthol e-cigarettes available), 3) menthol ban in both cigarettes and e-cigarettes (non-menthol cigarettes and tobacco e-cigarettes available). A follow-up survey at week 12 will assess tobacco use outcomes.

Official Title
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Evaluating the Potential Impact of a Menthol Ban in Cigarettes and E-cigarettes Among Current Menthol Smokers

Conditions
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Tobacco Smoking

Intervention / Treatment
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* Behavioral: menthol ban in cigarettes only
* Behavioral: total menthol ban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Age 21 or older Able to read English Currently smoking cigarettes Past experience and willing to use e-cigarettes In good general health Exclusion Criteria: Seeking smoking cessation treatment Serious psychiatric or medical condition Use of other drugs Unable or unwilling to complete study protocol Contraindications for study procedures based on medical history

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: no menthol ban<br>usual menthol cigarettes and menthol flavored e-cigarette available | |
| Experimental: menthol ban in cigarettes only<br>non-menthol cigarettes and menthol flavored e-cigarette available | Behavioral: menthol ban in cigarettes only<br>* menthol ban in cigarettes only, menthol available in e-cigarette<br>|
| Experimental: menthol ban in both cigarettes and e-cigarettes<br>non-menthol cigarettes and tobacco flavored e-cigarette available, | Behavioral: total menthol ban<br>* menthol ban in both cigarettes and e-cigarettes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of cigarettes smoked per day in the past week to evaluate changes in smoking behavior | Participants will report the total number of cigarettes consumed each day using the well-validated timeline follow-back (TLFB) interview methods to assess change. | From Week 0 to week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent days smoke-free | Participants will report the number of smoke free days over the 8 week study period. Percent days smoke-free will be determined using the TLFB interview methods. | From Week 0 to week 8 | 
| Changes in nicotine dependence using the Nicotine Dependence for Daily Smokers Scale | Changes in nicotine dependence will be measured using the Nicotine Dependence for Daily Smokers Scale from the NIH Patient Reported Outcome Measure Information System (PROMIS) bank. Scores are averaged across 4 items, min=1, max=5. Higher scores indicate greater nicotine dependence. | From Week 0 to week 8 | 
| Change in Quitting motivation and confidence | Quitting motivation and confidence will be assessed using the PhenX Toolkit using the items How motivated are you to quit smoking? and How confident are you that you could quit smoking if you tried? rated from 1 (not at all) to 10 (extremely). | Week 0 and week 8 | 
| Quit intentions using the Stages of Change Assessment | Participants will report their plans to quit smoking in the next 30 days based on Stages of Change Assessment, on a scale from 0 (I have absolutely no intention of quitting smoking) to 10 (I have made a firm decision to quit in the next 30 days). Higher scores indicate the more intention to quit. | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menthol, E-cigarette, cigarette