Menthol, Inflammation, and Nicotine Transition Study

Cigarette Smoking Clinical Trial

— MINT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06232447
• Other study ID #: CHP22-366
• Secondary ID: K01HL164670
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2024
• Est. completion date: February 2026

Study information

• Verified date: June 2024
• Source: Rosalind Franklin University of Medicine and Science
• Contact: Nancy C Jao, PhD
• Phone: 847-578-8747
• Email: nancy.jao[@]rosalindfranklin.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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, marijuana, or illicit substances

• History of severe medical/psychiatric condition or treatment

Related Conditions & MeSH terms

• Cigarette Smoking
• Inflammatory Response

Intervention

Other:
• Cigarette Type Switching
Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of four weeks

Locations

Country	Name	City	State
United States	Rosalind Franklin University of Medicine and Science	North Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rosalind Franklin University of Medicine and Science	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Affect	Positive and Negative Affect Scale (PANAS)	4 weeks
Other	Urge to smoke	Questionnaire on Smoking Urges-Brief (QSU)	4 weeks
Other	Nicotine Dependence	Fagerström Test for Cigarette Dependence (FTCD)	4 weeks
Other	Number of cigarettes smoked	Self-reported total number of menthol and non-menthol cigarettes smoked per day	4 weeks
Other	CO level	in ppm	4 weeks
Primary	high sensitivity C-reactive protein	from serum in mg/dL	4 weeks
Primary	Fibrinogen	from serum in mg/dL	4 weeks
Primary	Cytokine Panel 13	from serum in mg/dL	4 weeks
Secondary	Blood pressure	systolic blood pressure and diastolic blood pressure, in mm Hg	4 weeks
Secondary	Heart rate	beats per minute	4 weeks