Potential Impact of Menthol Ban in Cigarettes and E-cigarettes

Not Applicable

Recruiting

• Conditions: Tobacco Smoking
• Interventions: Behavioral: total menthol ban; Behavioral: menthol ban in cigarettes only

• Registration Number: NCT05259566
• Lead Sponsor: Yale University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-02-17
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-28
• Study Start: 2022-12-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Provision of signed and dated informed consent form
• Age 21 or older
• Able to read English
• Currently smoking cigarettes
• Willing to try e-cigarettes
• In good general health

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
menthol ban in both cigarettes and e-cigarettes	total menthol ban	non-menthol cigarettes and tobacco flavored e-cigarette available,
menthol ban in cigarettes only	menthol ban in cigarettes only	non-menthol cigarettes and menthol flavored e-cigarette available

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in nicotine dependence using the Nicotine Dependence for Daily Smokers Scale	From Week 0 to week 8	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.
Quit intentions using the Stages of Change Assessment	Week 8	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.
Percent days smoke-free	From Week 0 to week 8	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.
Change in Quitting motivation and confidence	Week 0 and week 8	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).

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States