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Recruiting

NCT Number: NCT06232447

Menthol, Inflammation, and Nicotine Transition Study

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.

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Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rosalind Franklin University of Medicine and Science

North Chicago, Illinois, 60064, United States

Location status: Recruiting

Location contact

Nancy C Jao, PhD

CONTACT

[email protected]

847-578-8747

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Cigarette Type Switching

Other

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

Primary outcomes

  1. high sensitivity C-reactive protein

    Time frame: 4 weeks

    from serum in mg/dL

  2. Fibrinogen

    Time frame: 4 weeks

    from serum in mg/dL

  3. Cytokine Panel 13

    Time frame: 4 weeks

    from serum in mg/dL

Secondary outcomes

  1. Blood pressure

    Time frame: 4 weeks

    systolic blood pressure and diastolic blood pressure, in mm Hg

  2. Heart rate

    Time frame: 4 weeks

    beats per minute

Other outcomes

  1. Affect

    Time frame: 4 weeks

    Positive and Negative Affect Scale (PANAS)

  2. Urge to smoke

    Time frame: 4 weeks

    Questionnaire on Smoking Urges-Brief (QSU)

  3. Nicotine Dependence

    Time frame: 4 weeks

    Fagerström Test for Cigarette Dependence (FTCD)

  4. Number of cigarettes smoked

    Time frame: 4 weeks

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

  5. CO level

    Time frame: 4 weeks

    in ppm

Study contacts

Contact information is provided by the study sponsor or research team.

Nancy C Jao, PhD

CONTACT

[email protected]

847-578-8747

Sponsors and collaborators

Lead sponsor

Rosalind Franklin University of Medicine and Science

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Effect of Menthol to Non-Menthol Cigarette Switching on Subclinical Inflammatory Biomarkers of Cardiovascular Health: Simulating a Menthol Cigarette Ban

Acronym: MINT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2024
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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