Menthol, Inflammation, and Nicotine Transition Study (MINT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Response; Cigarette Smoking
• Intervention / Treatment: Other: Cigarette Type Switching

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 Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nancy C Jao, PhD; Phone Number: 847-578-8747; Email: nancy.jao@rosalindfranklin.edu

Study Locations

• United States
  • Illinois
    • North Chicago, Illinois, United States, 60064
      • Recruiting
      • Rosalind Franklin University of Medicine and Science
      • Contact: Nancy C Jao, PhD; Phone Number: 847-578-8747; Email: nancy.jao@rosalindfranklin.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria

• Men and women between 21-60 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cigarette Type Switching; Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes	Other: Cigarette Type Switching; Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
high sensitivity C-reactive protein	from serum in mg/dL	4 weeks
Fibrinogen	from serum in mg/dL	4 weeks
Cytokine Panel 13	from serum in mg/dL	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	systolic blood pressure and diastolic blood pressure, in mm Hg	4 weeks
Heart rate	beats per minute	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Affect	Positive and Negative Affect Scale (PANAS)	4 weeks
Urge to smoke	Questionnaire on Smoking Urges-Brief (QSU)	4 weeks
Nicotine Dependence	Fagerström Test for Cigarette Dependence (FTCD)	4 weeks
Number of cigarettes smoked	Self-reported total number of menthol and non-menthol cigarettes smoked per day	4 weeks
CO level	in ppm	4 weeks

Collaborators and Investigators

• Sponsor: Rosalind Franklin University of Medicine and Science
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Nancy C Jao, PhD, Rosalind Franklin University of Medicine and Science

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CHP22-366; K01HL164670 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No