Cigarette SmokingMINTNCT06232447
Menthol, Inflammation, and Nicotine Transition Study
A study testing Cigarette Type Switching in people with Cigarette Smoking and Inflammatory Response, run by Rosalind Franklin University of Medicine and Science at 1 site in United States.
Trial summary
This study will focus on examining the potential impact of menthol flavoring in cigarettes on biomarkers of systemic inflammation as a subclinical indicator of cardiovascular disease risk. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking, Inflammatory Response
- What is being tested?
- Cigarette Type Switching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2024to Jun 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between 21-85 years old
- Currently uses menthol cigarettes
- Daily smoking rate of ≥5 cigarettes/day for ≥1 year
- Currently own and regularly use an iOS/Android smartphone device able to download the LifeData application
- Able to read and communicate fluently in English
Who cannot join
- Currently pregnant or breastfeeding
- Actively trying to quit smoking
- Current heavy alcohol use
- Frequent use of non-menthol cigarettes, other smoking products, or illicit substances
- History of severe medical/psychiatric condition or treatment
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
Rosalind Franklin University of Medicine and Science
North Chicago, Illinois, 60064
Nancy C Jao, PhD, 847-578-8747, nancy.jao@rosalindfranklin.edu
About this study
Official title: Effect of Menthol to Non-Menthol Cigarette Switching on Subclinical Inflammatory Biomarkers of Cardiovascular Health: Simulating a Menthol Cigarette Ban
This study will focus on examining the potential impact of menthol flavoring in cigarettes on biomarkers of systemic inflammation as a subclinical indicator of cardiovascular disease risk.
Read the detailed description
The goal of this study is to examine how switching from menthol (MC) to non-menthol (NMC) cigarette smoking may impact biomarkers of systemic inflammation, smoking behavior, and subjective responses related to smoking. MC smokers (N=68) will be recruited for a five-week study, with one-week of baseline of MC smoking (Phase 1), followed by four weeks of switching to study-provided, brand-matched NMCs (Phase 2). Biomarkers of systemic inflammation and tobacco exposure will be analyzed from blood samples before, during, and after switching for four weeks (baseline, week 1, week 3, and week 5). Ecological momentary assessment methods will also be gathered to measure patterns of smoking and smoking-related subjective responses (affect, craving).
- Conditions
- Cigarette Smoking, Inflammatory Response
- Being tested
- Cigarette Type Switching
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cigarette Type SwitchingOther
Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of four weeks
| Study group | Role | What they receive |
|---|---|---|
| Cigarette Type Switching | Experimental | Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes Receives: Other: Cigarette Type Switching |
What is being measured
The primary outcome is the main question the study is designed to answer.
high sensitivity C-reactive protein
from serum in mg/dL
Measured: 4 weeks
Fibrinogen
from serum in mg/dL
Measured: 4 weeks
Cytokine Panel 13
from serum in mg/dL
Measured: 4 weeks
Secondary outcomes (2)
Blood pressure
systolic blood pressure and diastolic blood pressure, in mm Hg
Measured: 4 weeks
Heart rate
beats per minute
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start26 Mar 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be asked to switch to smoking non-menthol cigarettes for four weeks.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rosalind Franklin University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Nancy Jao, Rosalind Franklin University of Medicine and Science
- Investigators
- Nancy C Jao, PhD, Principal investigator, Rosalind Franklin University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232447
- Sponsor's protocol ID
- CHP22-366
- Other IDs
- K01HL164670
- Acronym
- MINT
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2024
- Last updated
- 16 Apr 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Menthol to Non-Menthol Cigarette Switching on Subclinical Inflammatory Biomarkers of Cardiovascular Health: Simulating a Menthol Cigarette Ban
- ClinicalTrials.gov ID
- NCT06232447
- Acronym / sponsor ID
- MINT / CHP22-366
- Conditions
- Cigarette Smoking, Inflammatory Response
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Rosalind Franklin University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 Jan 2024 (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 focus on examining the potential impact of menthol flavoring in cigarettes on biomarkers of systemic inflammation as a subclinical indicator of cardiovascular disease risk.
Detailed description
The goal of this study is to examine how switching from menthol (MC) to non-menthol (NMC) cigarette smoking may impact biomarkers of systemic inflammation, smoking behavior, and subjective responses related to smoking. MC smokers (N=68) will be recruited for a five-week study, with one-week of baseline of MC smoking (Phase 1), followed by four weeks of switching to study-provided, brand-matched NMCs (Phase 2). Biomarkers of systemic inflammation and tobacco exposure will be analyzed from blood samples before, during, and after switching for four weeks (baseline, week 1, week 3, and week 5). Ecological momentary assessment methods will also be gathered to measure patterns of smoking and smoking-related subjective responses (affect, craving).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be asked to switch to smoking non-menthol cigarettes for four weeks.
| Arm | Type | Receives |
|---|---|---|
| Cigarette Type Switching | Experimental | Other: Cigarette Type SwitchingParticipants will be switched from smoking menthol cigarettes to non-menthol cigarettes |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women between 21-85 years old
- Currently uses menthol cigarettes
- Daily smoking rate of ≥5 cigarettes/day for ≥1 year
- Currently own and regularly use an iOS/Android smartphone device able to download the LifeData application
- Able to read and communicate fluently in English
Key exclusion criteria (5 listed)
- Currently pregnant or breastfeeding
- Actively trying to quit smoking
- Current heavy alcohol use
- Frequent use of non-menthol cigarettes, other smoking products, or illicit substances
- History of severe medical/psychiatric condition or treatment
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 |
|---|---|---|
| Cigarette Type SwitchingParticipants will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of four weeks | Other | Cigarette Type Switching |
Primary outcome
high sensitivity C-reactive protein
Time frame: 4 weeks
from serum in mg/dL
Fibrinogen
Time frame: 4 weeks
from serum in mg/dL
Cytokine Panel 13
Time frame: 4 weeks
from serum in mg/dL
2 secondary outcomes
Blood pressure
Time frame: 4 weeks
Heart rate
Time frame: 4 weeks
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 16 Apr 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.
Nancy C Jao, PhD principal investigator
Rosalind Franklin University of Medicine and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cigarette Type Switching in people with Cigarette Smoking and Inflammatory Response, run by Rosalind Franklin University of Medicine and Science 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 5 inclusion and 5 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 16 Apr 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 Nancy C Jao, PhD (847-578-8747, nancy.jao@rosalindfranklin.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high sensitivity C-reactive protein (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 16 Apr 2026.