Potential Impact of Menthol Ban in Cigarettes and E-cigarettes

Yale University

Status: Enrolling

Conditions: Tobacco Smoking

Treatments: Behavioral: menthol ban in cigarettes only; Behavioral: total menthol ban

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05259566

2000032211

1R01DA054993-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

no menthol ban

No Intervention group

Description:

usual menthol cigarettes and menthol flavored e-cigarette available

menthol ban in cigarettes only

Experimental group

Description:

non-menthol cigarettes and menthol flavored e-cigarette available

Treatment:

Behavioral: menthol ban in cigarettes only

menthol ban in both cigarettes and e-cigarettes

Experimental group

Description:

non-menthol cigarettes and tobacco flavored e-cigarette available,

Treatment:

Behavioral: total menthol ban