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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
menthol ban in cigarettes only, menthol available in e-cigarette
menthol ban in both cigarettes and e-cigarettes
Yale University
New Haven, Connecticut, United States
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.
Time frame: From Week 0 to week 8
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.
Time frame: 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.
Time frame: 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).
Time frame: Week 0 and week 8
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PREVENTION
Masking
SINGLE
Enrollment
151