Potential Impact of Menthol Ban in Cigarettes and E-cigarettes

Tobacco Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05259566
• Other study ID #: 2000032211
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: Krysten Bold, PhD
• Phone: 203-974-7603
• Email: Krysten.bold[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Tobacco Smoking

Intervention

Behavioral:
• menthol ban in cigarettes only
menthol ban in cigarettes only, menthol available in e-cigarette
• total menthol ban
menthol ban in both cigarettes and e-cigarettes

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent days of e-cigarette use	Participants will report the number of days using the e-cigarette over the 8 week study period using the TLFB interview	From Week 0 to week 8
Other	Number of quit attempts during follow-up	Number of quit attempts at the 12-week follow-up, measured by the TLFB interview methods.	Week 12
Primary	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	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
Secondary	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
Secondary	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
Secondary	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