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| ID | Type | Description | Link |
|---|---|---|---|
| K01HL164670 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cigarette Type Switching | Experimental | Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cigarette Type Switching | Other | Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of four weeks |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Affect | Positive and Negative Affect Scale (PANAS) | 4 weeks |
| Urge to smoke | Questionnaire on Smoking Urges-Brief (QSU) | 4 weeks |
Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nancy C Jao, PhD | Contact | 847-578-8747 | nancy.jao@rosalindfranklin.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nancy C Jao, PhD | Rosalind Franklin University of Medicine and Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rosalind Franklin University of Medicine and Science | Recruiting | North Chicago | Illinois | 60064 | United States |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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All participants will be asked to switch to smoking non-menthol cigarettes for four weeks.
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| 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 |