Comparing menthol and tobacco-flavored e-cigarettes for adult menthol smokers
The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers
This study tests whether menthol-flavored e-cigarettes help adult menthol smokers switch from regular cigarettes better than tobacco-flavored ones.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT05555069 on ClinicalTrials.gov |
What this trial studies
This study evaluates how effective menthol-flavored e-cigarettes are compared to tobacco-flavored ones in helping adult menthol smokers switch from combustible cigarettes to e-cigarettes. A total of 800 menthol smokers will be randomly assigned to use either flavor for 12 weeks, with follow-up extending to 26 weeks. The primary goal is to measure the rate of switching from traditional cigarettes to e-cigarettes at the 12-week mark.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who smoke at least 5 menthol cigarettes per day and are interested in switching to e-cigarettes.
Not a fit: Patients who are actively seeking to quit smoking or have used other tobacco products recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective method for menthol smokers to transition away from combustible cigarettes, potentially improving their health outcomes.
How similar studies have performed: Other studies have shown varying degrees of success with e-cigarette interventions, but this specific comparison of menthol versus tobacco flavors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kansas City, Missouri
- University of Kansas Medical Center — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Nicole Nollen, PhD — University of Kanas Medical Center
- Study coordinator: Tricia Snow
- Email: psnow@kumc.edu
- Phone: 816-398-8960
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.