Menthol, Inflammation, and Nicotine Transition Study (MINT)

Rosalind Franklin University of Medicine and Science

Status: Enrolling

Conditions: Cigarette Smoking; Inflammatory Response

Treatments: Other: Cigarette Type Switching

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06232447

K01HL164670 (U.S. NIH Grant/Contract)

CHP22-366

Details and patient eligibility

About

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.

Full 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).

Enrollment: 68 estimated patients

Sex: All

Ages: 21 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

68 participants in 1 patient group

Cigarette Type Switching

Experimental group

Description:

Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes

Treatment:

Other: Cigarette Type Switching