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The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

N

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)

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

Trial contacts and locations

1

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Central trial contact

Tricia Snow

Data sourced from clinicaltrials.gov

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