Clinical trial NCT06232447: Menthol, Inflammation, and Nicotine Transition Study
Official title: Effect of Menthol to Non-Menthol Cigarette Switching on Subclinical Inflammatory Biomarkers of Cardiovascular Health: Simulating a Menthol Cigarette Ban
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cigarette Smoking
Inflammatory Response
Lead sponsor: Rosalind Franklin University of Medicine and Science
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-01-30
Enrollment: 68
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will be asked to switch to smoking non-menthol cigarettes for four weeks.
Primary purpose: BASIC_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).

Eligibility 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

Primary outcomes:
measure: high sensitivity C-reactive protein
timeFrame: 4 weeks
measure: Fibrinogen
timeFrame: 4 weeks
measure: Cytokine Panel 13
timeFrame: 4 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: 4 weeks
measure: Heart rate
timeFrame: 4 weeks
Other outcomes:
measure: Affect
timeFrame: 4 weeks
measure: Urge to smoke
timeFrame: 4 weeks
measure: Nicotine Dependence
timeFrame: 4 weeks
measure: Number of cigarettes smoked
timeFrame: 4 weeks
measure: CO level
timeFrame: 4 weeks
Locations:
city: North Chicago
country: United States
facility: Rosalind Franklin University of Medicine and Science
state: Illinois
Study officials:
affiliation: Rosalind Franklin University of Medicine and Science
name: Nancy C Jao, PhD
role: PRINCIPAL_INVESTIGATOR
References: