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NCT06232447NARecruitingAccepts Healthy Volunteers

Menthol, Inflammation, and Nicotine Transition Study

Rosalind Franklin University of Medicine and Science

Start Date

3/26/2024

Completion Date

6/1/2027

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).

Eligibility Criteria

Age Range: 21 years to 85 years

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

Interventions

OTHER

Cigarette Type Switching

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Conditions

Cigarette SmokingInflammatory Response

Locations

Rosalind Franklin University of Medicine and Science

North Chicago, Illinois 60064

United States