The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking Reduction
• Intervention / Treatment: Other: Menthol-flavored electronic cigarette; Other: Tobacco-flavored electronic cigarette

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
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tricia Snow; Phone Number: 816-398-8960; Email: psnow@kumc.edu

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64130
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Tricia Snow; Phone Number: 816-398-8960; Email: psnow@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who switch from cigarettes to electronic cigarettes at 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.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of respiratory symptoms using spirometry	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.	Week 12
Amount of e-liquid consumed	E-liquid consumed will be measured in both groups as a measure of acceptability of menthol versus tobacco e-cigarettes.	Week 12

Collaborators and Investigators

• Sponsor: Nikki Nollen, PhD, MA
• Investigators: Principal Investigator: Nicole Nollen, PhD, University of Kanas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Smoking; Health Behavior; Smoking Reduction; Dermatologic Agents; Antipruritics; Menthol
• Other Study ID Numbers: STUDY00148382

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No