Effect of Menthol to Non-Menthol Cigarette Switching on Subclinical Inflammatory Biomarkers of Cardiovascular Health: Simulating a Menthol Cigarette Ban
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Cytokine Panel 13
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cigarette Type Switching
Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes
干预措施: Cigarette Type Switching (Other)
结局指标
主要结局
Cytokine Panel 13
时间窗: 4 weeks
from serum in mg/dL
high sensitivity C-reactive protein
时间窗: 4 weeks
from serum in mg/dL
Fibrinogen
时间窗: 4 weeks
from serum in mg/dL
次要结局
- Blood pressure(4 weeks)
- Heart rate(4 weeks)
研究者
Nancy Jao
Assistant Professor
Rosalind Franklin University of Medicine and Science