The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

Nikki Nollen, PhD, MA

Status: Enrolling

Conditions: Smoking Reduction

Treatments: Other: Menthol-flavored electronic cigarette; Other: Tobacco-flavored electronic cigarette

Study type: Interventional

Funder types: Other

Identifiers

NCT05555069

STUDY00148382

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

Menthol Flavor Electronic Cigarette

Active Comparator group

Description:

400 adult cigarette smokers will receive 12 weeks of menthol-flavored electronic cigarettes.

Treatment:

Other: Menthol-flavored electronic cigarette

Tobacco Flavor Electronic Cigarette

Active Comparator group

Description:

400 adult cigarette smokers will receive 12 weeks of tobacco-flavored electronic cigarettes.

Treatment:

Other: Tobacco-flavored electronic cigarette