NCT05555069NARecruitingAccepts Healthy Volunteers
The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers
Nikki Nollen, PhD, MA
Start Date
11/8/2022
Completion Date
3/31/2027
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.
Detailed 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 Criteria
Age Range: 21 years to No maximum
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 getting pregnant, or breastfeeding
* Plans to move from Kansas City during the treatment and follow-up phase
* Another household member enrolled in the study
Interventions
OTHER
Menthol-flavored electronic cigarette
OTHER
Tobacco-flavored electronic cigarette
Conditions
Smoking Reduction
Locations
University of Kansas Medical Center
Kansas City, Missouri 64130
United States