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NCT05555069 | Recruiting | Smoking Reduction


The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers
Sponsor:

Nikki Nollen, PhD, MA

Information provided by (Responsible Party):

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.

Condition or disease

Smoking Reduction

Intervention/treatment

Menthol-flavored electronic cigarette

Tobacco-flavored electronic cigarette

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 800 participants
Masking : None (Open Label)
Primary Purpose : Prevention
Official Title : The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers
Actual Study Start Date : November 8, 2022
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : November 30, 2025
Arm Intervention/treatment

Active Comparator: Menthol Flavor Electronic Cigarette

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

Other: Menthol-flavored electronic cigarette

Active Comparator: Tobacco Flavor Electronic Cigarette

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

Other: Tobacco-flavored electronic cigarette

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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

The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

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The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

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Locations


Recruiting

United States, Missouri

University of Kansas Medical Center

Kansas City, missouri, United States, 64130

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