Recruiting

Menthol Flavoring

Sponsor:

Nikki Nollen, PhD, MA

Code:

NCT05555069

Conditions

Smoking Reduction

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Menthol-flavored electronic cigarette

Tobacco-flavored electronic cigarette

Study Details

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.

Conditions

Smoking Reduction

Study ID

NCT05555069

Start date

Nov 8, 2022

Status verified date

Jan, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Menthol Flavor Electronic Cigarette

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

active comparator: Tobacco Flavor Electronic Cigarette

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

Interventions

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.

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.

Primary outcome measure

  • Number of participants who switch from cigarettes to electronic cigarettes at Week 12 [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Tricia Snow

816-398-8960psnow@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Missouri, United States, 64130

Contacts

Tricia Snow

816-398-8960psnow@kumc.edu

More Information

Sponsor

Nikki Nollen, PhD, MA

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nikki Nollen, PhD, MA on 2026-01-23.