NCT06232447

Menthol, Inflammation, and Nicotine Transition Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Rosalind Franklin University of Medicine and Science · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
OTHER	Cigarette Type Switching	Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of four weeks

Timeline

• Start date: 2024-03-26
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2024-01-30
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States