NCT05555069

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Nov 2022Mar 2027

First Submitted

Initial submission to the registry

September 15, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 8, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

4.1 years

First QC Date

September 15, 2022

Last Update Submit

January 21, 2026

Conditions

Smoking Reduction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Assessment of respiratory symptoms using spirometry

    Week 12

  • Amount of e-liquid consumed

    Week 12

Study Arms (2)

Menthol Flavor Electronic Cigarette

ACTIVE COMPARATOR

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

Other: Menthol-flavored electronic cigarette

Tobacco Flavor Electronic Cigarette

ACTIVE COMPARATOR

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

Other: Tobacco-flavored electronic cigarette

Interventions

Menthol-flavored electronic cigaretteOTHER

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.

Menthol Flavor Electronic Cigarette
Tobacco-flavored electronic cigaretteOTHER

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.

Tobacco Flavor Electronic Cigarette

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Missouri, 64130, United States

RECRUITING

MeSH Terms

Conditions

Smoking Reduction

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSmoking

Study Officials

  • Nicole Nollen, PhD

    University of Kanas Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tricia Snow

CONTACT

816-398-8960psnow@kumc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 26, 2022

Study Start

November 8, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

US(1)