The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

Purpose

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

  • Smoking Reduction

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Menthol Flavor Electronic Cigarette 		400 adult cigarette smokers will receive 12 weeks of menthol-flavored electronic cigarettes.
  • Other: Menthol-flavored electronic cigarette
    Participants will receive 12 weeks of menthol -flavored electronic cigarettes to aid in switching from combustible cigarettes. Participants will be instructed on proper use of the electronic cigarettes, educated about electronic cigarettes and participate in motivation enhancement and substituting electronic cigarettes for cigarettes.
Active Comparator
Tobacco Flavor Electronic Cigarette 		400 adult cigarette smokers will receive 12 weeks of tobacco-flavored electronic cigarettes.
  • Other: Tobacco-flavored electronic cigarette
    Participants will receive 12 weeks of tobacco-flavored electronic cigarettes to aid in switching from combustible cigarettes. Participants will be instructed on proper use of the electronic cigarettes, educated about electronic cigarettes and participate in motivation enhancement and substituting electronic cigarettes for cigarettes.

Recruiting Locations

University of Kansas Medical Center
Kansas City, Missouri 64130
Contact:
Tricia Snow
816-398-8960
psnow@kumc.edu

More Details

Status
Recruiting
Sponsor
Nikki Nollen, PhD, MA

Study Contact

Tricia Snow
816-398-8960
psnow@kumc.edu

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.