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NCT Number: NCT05555069

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.

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Key information

Conditions

Smoking Reduction Behavior Health Behavior Smoking

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Missouri, 64130, United States

Location status: Recruiting

Location contact

Tricia Snow

CONTACT

[email protected]

816-398-8960

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Menthol-flavored electronic cigarette

Other

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.

Tobacco-flavored electronic cigarette

Other

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.

Primary outcomes

  1. Number of participants who switch from cigarettes to electronic cigarettes at Week 12

    Time frame: 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.

Secondary outcomes

  1. Assessment of respiratory symptoms using spirometry

    Time frame: Week 12

    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.

  2. Amount of e-liquid consumed

    Time frame: Week 12

    E-liquid consumed will be measured in both groups as a measure of acceptability of menthol versus tobacco e-cigarettes.

Study contacts

Contact information is provided by the study sponsor or research team.

Tricia Snow

CONTACT

[email protected]

816-398-8960

Sponsors and collaborators

Lead sponsor

Nikki Nollen, PhD, MA

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Sep 26, 2022
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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