Smoking ReductionNCT05555069
The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers
A study testing Menthol-flavored electronic cigarette and Tobacco-flavored electronic cigarette in people with Smoking Reduction, run by Nikki Nollen, PhD, MA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Reduction
- What is being tested?
- Menthol-flavored electronic cigarette and Tobacco-flavored electronic cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2022to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Missouri, 64130
Tricia Snow, 816-398-8960, psnow@kumc.edu
About this study
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.
Read the 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.
- Conditions
- Smoking Reduction
- Being tested
- Menthol-flavored electronic cigarette, Tobacco-flavored electronic cigarette
- Medical subject headings
- Smoking Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Menthol Flavor Electronic Cigarette | Active comparator | 400 adult cigarette smokers will receive 12 weeks of menthol-flavored electronic cigarettes. Receives: Other: Menthol-flavored electronic cigarette |
| Tobacco Flavor Electronic Cigarette | Active comparator | 400 adult cigarette smokers will receive 12 weeks of tobacco-flavored electronic cigarettes. Receives: Other: Tobacco-flavored electronic cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (2)
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.
Measured: 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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start8 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nikki Nollen, PhD, MA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nikki Nollen, PhD, MA, University of Kansas Medical Center
- Investigators
- Nicole Nollen, PhD, Principal investigator, University of Kanas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555069
- Sponsor's protocol ID
- STUDY00148382
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers
- ClinicalTrials.gov ID
- NCT05555069
- Acronym / sponsor ID
- STUDY00148382
- Conditions
- Smoking Reduction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Nikki Nollen, PhD, MAUniversity, hospital or other
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menthol Flavor Electronic Cigarette | Active comparator | Other: Menthol-flavored electronic cigarette400 adult cigarette smokers will receive 12 weeks of menthol-flavored electronic cigarettes. |
| Tobacco Flavor Electronic Cigarette | Active comparator | Other: Tobacco-flavored electronic cigarette400 adult cigarette smokers will receive 12 weeks of tobacco-flavored electronic cigarettes. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 21 years of age
- Smoke ≥ 5 cigarettes per day (CPD)
- Smoke menthol cigarettes for ≥ 6 months
- Verified smoker (CO >5ppm)
- Functioning telephone
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menthol-flavored electronic cigaretteParticipants 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. | Other | Menthol Flavor Electronic Cigarette |
| Tobacco-flavored electronic cigaretteParticipants 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. | Other | Tobacco Flavor Electronic Cigarette |
Primary outcome
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.
2 secondary outcomes
Assessment of respiratory symptoms using spirometry
Time frame: Week 12
Amount of e-liquid consumed
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole Nollen, PhD principal investigator
University of Kanas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menthol-flavored electronic cigarette and Tobacco-flavored electronic cigarette in people with Smoking Reduction, run by Nikki Nollen, PhD, MA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tricia Snow (816-398-8960, psnow@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who switch from cigarettes to electronic cigarettes at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.