The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

Not Applicable

Recruiting

• Conditions: Smoking Reduction
• Interventions: Other: Menthol-flavored electronic cigarette; Other: Tobacco-flavored electronic cigarette

• Registration Number: NCT05555069
• Lead Sponsor: Nikki Nollen, PhD, MA

Brief 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.

Study Timeline

• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-26
• Study Start: 2022-11-08
• Status Verified: 2024-05
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20
• Primary Completion: 2026-11-30
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Menthol Flavor Electronic Cigarette	Menthol-flavored electronic cigarette	400 adult cigarette smokers will receive 12 weeks of menthol-flavored electronic cigarettes.
Tobacco Flavor Electronic Cigarette	Tobacco-flavored electronic cigarette	400 adult cigarette smokers will receive 12 weeks of tobacco-flavored electronic cigarettes.

Primary Outcome Measures

Name	Time	Method
Number of participants who switch from cigarettes to electronic cigarettes at Week 12	Week 12	Complete switching is defined as exclusive use of e-cigarettes, confirmed with CO\< 6ppm and predominant switching; defined as use of the e-cigarette with \>50% reduction in CPD. This will compare the effectiveness of menthol versus tobacco e-cigarettes at facilitating switching at Week 12.

Secondary Outcome Measures

Name	Time	Method
Amount of e-liquid consumed	Week 12	E-liquid consumed will be measured in both groups as a measure of acceptability of menthol versus tobacco e-cigarettes.
Assessment of respiratory symptoms using spirometry	Week 12	Spirometry summarizing forced expiratory flow (FEF) 25-75% and the American Thoracic Society Questionnaire will assess will assess acute respiratory symptoms experienced by cigarette and electronic cigarette smokers. This will help assess the tobacco harm reduction of electronic cigarettes.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Missouri, United States