Menthol, Inflammation, and Nicotine Transition Study

Last updated: April 14, 2025
Sponsor: Rosalind Franklin University of Medicine and Science
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammation

Treatment

Cigarette Type Switching

Clinical Study ID

NCT06232447
CHP22-366
K01HL164670
  • Ages 21-85
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 68
Treatment Group(s): 1
Primary Treatment: Cigarette Type Switching
Phase:
Study Start date:
March 26, 2024
Estimated Completion Date:
June 30, 2026

Study 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).

Connect with a study center

  • Rosalind Franklin University of Medicine and Science

    North Chicago, Illinois 60064
    United States

    Active - Recruiting

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