Menthol, Inflammation, and Nicotine Transition Study
Purpose
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.
Conditions
- Cigarette Smoking
- Inflammatory Response
Eligibility
- Eligible Ages
- Between 21 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- All participants will be asked to switch to smoking non-menthol cigarettes for four weeks.
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cigarette Type Switching |
Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes |
|
Recruiting Locations
North Chicago 4903862, Illinois 4896861 60064
More Details
- Status
- Recruiting
- Sponsor
- Rosalind Franklin University of Medicine and Science
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).