Nicotine Uptake and Abuse Liability Assessments of 5 Blu Disposable Electronic Cigarettes in Comparison to a Combustible Cigarette
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Nicotine AUC0-120
研究概览
简要总结
This study assesses the nicotine uptake, abuse liability and puffing topography of blu disposable e-cigarettes in adult combustible cigarette smokers. Nicotine uptake, subjective effects, and puff topography are evaluated and compared with subjects' usual brand combustible cigarette.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Subjects must be current smokers (≥10 per day) of combustible cigarettes for at least 6 continuous months before Visit 1 and may be occasional users of e-cigarettes
- •Subjects have urine cotinine >200 ng/mL and exhaled carbon monoxide > 10 ppm at Screening
- •Subject has a seated systolic blood pressure ≤160 mmHg, diastolic blood pressure
- •≤95 mmHg, and heart rate ≤100 bpm
- •Females of childbearing potential who are practicing a reliable method of contraception
排除标准
- •Subjects who have used any nicotine or tobacco product other than e-cigarettes or combustible cigarettes in the 14 days prior to Visit 1
- •Subjects who have an acute illness requiring treatment in the 4 weeks prior to Visit 1
- •Subjects with clinically significant and relevant abnormalities of medical history.
- •Subjects who have used any prescription or over-the-counter smoking cessation treatments within 30 days prior to Visit 1
- •Pregnant or breastfeeding female subjects
研究组 & 干预措施
blu Disposable Flavor A
Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor A
干预措施: blu Disposable A (Other)
blu Disposable Flavor B
Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor B
干预措施: blu Disposable B (Other)
blu Disposable Flavor C
Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor C
干预措施: blu Disposable C (Other)
blu Disposable Flavor D
Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor D
干预措施: blu Disposable D (Other)
blu Disposable Flavor E
Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor E
干预措施: blu Disposable E (Other)
Combustible cigarette
Subjects who use their own brand of combustible cigarette
干预措施: Combustible Cigarette (Other)
结局指标
主要结局
Nicotine AUC0-120
时间窗: 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff
Area under the plasma nicotine concentration-time curve from time 0 to 120 minutes during the defined use session
Urge to Smoke - Defined use
时间窗: 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff
Subjects answer "How strong is your current urge to smoke your usual brand cigarette?" on a Visual Analog Scale: from "No Urge" at the left to "Very Strong Urge" at the right.
Urge to Smoke - Ad libitum use
时间窗: at 15, 30, 45, and 60 minutes after the start of the ad libitum use session
Subjects answer "How strong is your current urge to smoke your usual brand cigarette?" on a Visual Analog Scale: from "No Urge" at the left to "Very Strong Urge" at the right.
Nicotine Cmax0-120
时间窗: 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff
Maximum plasma nicotine concentration, during the defined use session, adjusted for baseline nicotine
Nicotine Cmax120-180
时间窗: at 15, 30, 45, and 60 minutes after the start of the ad libitum use session (ad libitum session starts at 120 min relative to first puff of controlled use session)
Maximum plasma nicotine concentration during the ad libitum use session, adjusted for baseline nicotine
Nicotine AUC120-180
时间窗: at 15, 30, 45, and 60 minutes after the start of the ad libitum use session
Area under the plasma nicotine concentration-time curve from time 120 minutes to 180 minutes, i.e. during the ad libitum use session
次要结局
- Puff topography: puff count(Throughout ad libitum use session (60 minutes))