Tobacco Smoking
Conditions
Keywords
menthol, E-cigarette, cigarette
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.
Interventions
BEHAVIORALmenthol ban in cigarettes only
menthol ban in cigarettes only, menthol available in e-cigarette
BEHAVIORALtotal menthol ban
menthol ban in both cigarettes and e-cigarettes
Sponsors
Yale University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKrysten Bold, PhD
Yale University
Outcome results
None listed