Cardiovascular Effects of Very Low Nicotine Content Cigarettes
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Change in Heart rate - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)
研究概览
简要总结
The study is measuring Cardiovascular effects of very low nicotine content cigarettes on daily and non-daily smokers
详细描述
The FDA is planning regulatory actions to limit nicotine levels in cigarettes as far as it is not reduced to zero. The strategy is designed to reduce the addictiveness of cigarettes. However, nicotine related effects of the cigarettes with reduced nicotine content on various body systems are largely unknown. Following formal implementation of the regulatory policy what cardiovascular effects of reduced nicotine cigarettes, also called very low nicotine content cigarettes (VLNCC) are expected to persist is important to determine. This study will determine the cardiovascular effects of VLNCC such as change in heart rate, autonomic functions and indices of ventricular repolarization in smokers. Participants will be asked to smoke two VLNCC and one normal nicotine content cigarette (NNCC) while we will be recording their electrocardiogram (ECG) to see a change in heart rate, heart rate variability and indices of ventricular repolarization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to content of nicotine in cigarettes
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-reported cigarette smoking at least once in the past 30 days
- •≥21 years old
- •Willingness to smoke research cigarettes or usual brand cigarettes during lab visit.
- •Ability to speak, comprehend, and read English sufficiently to complete study procedures
排除标准
- •Self-reported diagnosis of cardiovascular diseases like coronary artery disease, stroke, peripheral artery disease, cardiac arrhythmia, pulmonary embolism & blood clots in legs and arm in the past 3 months
- •Body temperature ≥ 100.4˙F
- •Unstable health conditions interfering with electrocardiogram (ECG) measurements
- •Self-reported diagnosis of hyperthyroidism or thyrotoxicosis
- •Currently pregnant (as indicated by urine pregnancy test at the start of laboratory visit) or breastfeeding.
- •Currently seeking treatment to quit smoking
研究组 & 干预措施
Research Cigarettes (SPECTRUM)
Participants will smoke 1-2 SPECTRUM cigarettes
干预措施: SPECTRUM cigarettes (Drug)
Usual Brand of Cigarettes
Participants will smoke 2-3 cigarettes of their usual brand
干预措施: usual brand of Cigarettes (Other)
结局指标
主要结局
Change in Heart rate - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)
时间窗: Hour 1
Change in heart rate from pre-exposure to post-exposure for the Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)
Change in Heart rate - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine)
时间窗: Hour 1
Change in heart rate from pre-exposure to post-exposure for the Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine)
Change in Heart rate - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)
时间窗: Hour 1
Change in heart rate from pre-exposure to post-exposure for the normal nicotine content cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)
次要结局
- Change in Heart rate variability(HRV) - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine)(Hour 1)
- Change in Heart rate variability(HRV) - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)(Hour 1)
- Change in Heart rate variability(HRV) - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)(Hour 1)
- Change in electrocardiogram (ECG) Measures - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)(Hour 1)
- Change in electrocardiogram (ECG) Measures - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)(Hour 1)
- Change in electrocardiogram (ECG) Measures - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC300/301(2.4mg nicotine)(Hour 1)