The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers
Nikki Nollen, PhD, MA
Summary
This study will compare the efficacy of menthol-flavored versus tobacco-flavored 4th generation nicotine salt-based pod-system e-cigarettes in facilitating a switch from combustible cigarettes to e-cigarettes in adult menthol smokers.
Description
Menthol smokers (n=800), stratified by race, will be randomized 1:1 into a 12-week open label, non-inferiority trial comparing a 4th generation nicotine salt-based pod-system e-cigarette in menthol- versus tobacco-flavored e-liquid. Follow-up will continue through week 26. The primary outcome is rate of switching from combustible cigarettes to e-cigarettes at week 12.
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * ≥ 21 years of age * Smoke ≥ 5 cigarettes per day (CPD) * Smoke menthol cigarettes for ≥ 6 months * Verified smoker (CO \>5ppm) * Functioning telephone * Interested in switching to E-cigarettes Exclusion Criteria: * Interested in quitting smoking * Use of other tobacco products in past 30 days (i.e. cigarillos, cigars, hookah, smokeless tobacco, pipes) * E-cigarette use on ≥ 4 of the past 30 days * Uncontrolled hypertension: BP ≥ 180(systolic) or ≥ 105 (diastolic) * Use of smoking cessation pharmacotherapy in the month prior to enrollment * Pregnant, contemplating getti…
Interventions
- OtherMenthol-flavored electronic cigarette
Participants will receive 12 weeks of menthol -flavored electronic cigarettes to aid in switching from combustible cigarettes. Participants will be instructed on proper use of the electronic cigarettes, educated about electronic cigarettes and participate in motivation enhancement and substituting electronic cigarettes for cigarettes.
- OtherTobacco-flavored electronic cigarette
Participants will receive 12 weeks of tobacco-flavored electronic cigarettes to aid in switching from combustible cigarettes. Participants will be instructed on proper use of the electronic cigarettes, educated about electronic cigarettes and participate in motivation enhancement and substituting electronic cigarettes for cigarettes.
Location
- University of Kansas Medical CenterKansas City, Missouri