Menthol, Inflammation, and Nicotine Transition Study

Not Applicable

Recruiting

• Conditions: Inflammatory Response; Cigarette Smoking
• Interventions: Other: Cigarette Type Switching

• Registration Number: NCT06232447
• Lead Sponsor: Rosalind Franklin University of Medicine and Science

Brief 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).

Study Timeline

• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-30
• Study Start: 2024-03-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cigarette Type Switching	Cigarette Type Switching	Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes

Primary Outcome Measures

Name	Time	Method
Cytokine Panel 13	4 weeks	from serum in mg/dL
high sensitivity C-reactive protein	4 weeks	from serum in mg/dL
Fibrinogen	4 weeks	from serum in mg/dL

Secondary Outcome Measures

Name	Time	Method
Blood pressure	4 weeks	systolic blood pressure and diastolic blood pressure, in mm Hg
Heart rate	4 weeks	beats per minute

Trial Locations

Locations (1)

Rosalind Franklin University of Medicine and Science; 🇺🇸 North Chicago, Illinois, United States