A Study to Characterize Puff Topography With Use of a JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Puff Topography Parameter - Average Puff Flow Rate
研究概览
简要总结
A Study to Characterize Puff Topography with Use of a JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
详细描述
This will be an open label study to evaluate puff topography in adult smokers using a JUUL 5% ENDS. Up to 30 subjects will be enrolled and evaluated on Day 1 and Day 15. The duration of the study is 15 days with up to a 28 days screening window.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, male or female smoker, 21 to 65 years of age
- •Has been a smoker for at least 12 months prior to Screening.
- •Currently smokes an average of 5 to 40 manufactured combustible (menthol or non menthol) cigarettes per day.
- •A female subject of childbearing potential must have been using 1 of the following forms of contraception and agree to continue using it through completion of the study
- •Provides voluntary consent to participate in this study documented on the signed informed consent form.
排除标准
- •Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ECG, or clinical laboratory results, in the opinion of the PI.
- •Has a body mass index (BMI) > 40 kg/m2 or < 18 kg/m2 at Screening.
- •Has a history of drug or alcohol abuse within 24 months of Day
- •If female, the subject is pregnant, lactating, or intends to become pregnant during the time period from Screening through the end of study.
结局指标
主要结局
Puff Topography Parameter - Average Puff Flow Rate
时间窗: 15 days
To characterize overall average puff flow
Puff Topography Parameter - Puff Duration
时间窗: 15 days
To characterize overall puff duration
Puff Topography Parameter - Peak Puff Flow Rate
时间窗: 15 days
To characterize overall peak puff flow rate
Puff Topography Parameter - Inter-Puff Interval
时间窗: 15 days
To characterize overall inter-puff interval (time between puffs)
Puff Topography Parameter - Puff Volume
时间窗: 15 days
To characterize overall puff volume
次要结局
- Subjective measure of product liking(15 days)
- Subject measure of affect(15 days)
- Self-reported product use over 15-day period(15 days)
- Subjective measure of cigarette dependence(15 days)
- Subjective measure of nicotine withdrawal(15 days)
- Subjective measure of smoking urges(15 days)
- Subjective measure of effects of nicotine(15 days)