Cigarette Smoking, Inflammatory Response
Conditions
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).
Interventions
OTHERCigarette Type Switching
Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of four weeks
Sponsors
Rosalind Franklin University of Medicine and Science
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
All participants will be asked to switch to smoking non-menthol cigarettes for four weeks.
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| high sensitivity C-reactive protein | 4 weeks | from serum in mg/dL |
| Fibrinogen | 4 weeks | from serum in mg/dL |
| Cytokine Panel 13 | 4 weeks | from serum in mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 4 weeks | systolic blood pressure and diastolic blood pressure, in mm Hg |
| Heart rate | 4 weeks | beats per minute |
Countries
United States
Contacts
CONTACTNancy C Jao, PhD
PRINCIPAL_INVESTIGATORNancy C Jao, PhD
Rosalind Franklin University of Medicine and Science
Outcome results
None listed