Clinical trial NCT05259566: Potential Impact of Menthol Ban in Cigarettes and E-cigarettes
Official title: Evaluating the Potential Impact of a Menthol Ban in Cigarettes and E-cigarettes Among Current Menthol Smokers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Smoking
Keywords: menthol
E-cigarette
cigarette
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-02-28
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average number of cigarettes smoked per day in the past week to evaluate changes in smoking behavior
timeFrame: From Week 0 to week 8
Secondary outcomes:
measure: Percent days smoke-free
timeFrame: From Week 0 to week 8
measure: Changes in nicotine dependence using the Nicotine Dependence for Daily Smokers Scale
timeFrame: From Week 0 to week 8
measure: Change in Quitting motivation and confidence
timeFrame: Week 0 and week 8
measure: Quit intentions using the Stages of Change Assessment
timeFrame: Week 8
Other outcomes:
measure: Percent days of e-cigarette use
timeFrame: From Week 0 to week 8
measure: Number of quit attempts during follow-up
timeFrame: Week 12
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Krysten Bold, PhD
role: PRINCIPAL_INVESTIGATOR
References: