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RecruitingNCT06232447MINTUpdated Apr 16, 2026

Menthol, Inflammation, and Nicotine Transition Study

An interventional study of Cigarette Type Switching in Cigarette Smoking and Inflammatory Response, sponsored by Rosalind Franklin University of Medicine and Science. Recruiting at 1 site in United States. Open to participants aged 21 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by Rosalind Franklin University of Medicine and Science · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Not applicable
Ages
21 Years to 85 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Cigarette Smoking
  • Inflammatory Response

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03

Who can participate

Ages eligible
21 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    Cigarette Type Switching

    Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes

    Other: Cigarette Type Switching

Interventions

  • OtherCigarette Type Switching

    Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of four weeks

05

What researchers measure

Primary outcomes

  1. high sensitivity C-reactive protein

    from serum in mg/dL

    Time frame: 4 weeks

  2. Fibrinogen

    from serum in mg/dL

    Time frame: 4 weeks

  3. Cytokine Panel 13

    from serum in mg/dL

    Time frame: 4 weeks

Secondary outcomes

  1. Blood pressure

    systolic blood pressure and diastolic blood pressure, in mm Hg

    Time frame: 4 weeks

  2. Heart rate

    beats per minute

    Time frame: 4 weeks

Other outcomes

  1. Affect

    Positive and Negative Affect Scale (PANAS)

    Time frame: 4 weeks

  2. Urge to smoke

    Questionnaire on Smoking Urges-Brief (QSU)

    Time frame: 4 weeks

  3. Nicotine Dependence

    Fagerström Test for Cigarette Dependence (FTCD)

    Time frame: 4 weeks

  4. Number of cigarettes smoked

    Self-reported total number of menthol and non-menthol cigarettes smoked per day

    Time frame: 4 weeks

  5. CO level

    in ppm

    Time frame: 4 weeks

06

Study locations

1 of 1 sites recruiting
  • Rosalind Franklin University of Medicine and Science
    North Chicago, Illinois 60064, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT06232447
Lead sponsor
Rosalind Franklin University of Medicine and Science
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Nancy Jao (Assistant Professor, Rosalind Franklin University of Medicine and Science) — Principal investigator
First posted
Jan 30, 2024
Start date
Mar 26, 2024
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Apr 16, 2026

Study contacts

Nancy C Jao, PhD
Contact
nancy.jao@rosalindfranklin.edu
847-578-8747
Nancy C Jao, PhD
principal investigator · Rosalind Franklin University of Medicine and Science

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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