Characterization of Nicotine Exposure and Urge-to-Smoke Following a Single Controlled Administration and Short-Term Ad Lib Use of Electronic Cigarettes and Conventional Cigarettes in Adult Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Profile nicotine pharmacokinetics following use of e-cigs and regular cigarettes
研究概览
简要总结
This trial was the initial characterization of the blu™ products being studied, with the purpose of gaining an understanding of the exposure to nicotine and craving reduction attained following use of blu™ e-cigarettes by adult smokers. Two types of exposures were utilized: a single controlled administration and a short-term ad lib use. As smoking behaviors vary from smoker to smoker, a controlled administration allows for some standardization of nicotine "dose" for each of the study products to better understand their uptake characteristics as well as urge reduction achieved under controlled conditions. Further evaluation under ad lib product use conditions provides insight into product self-administration behaviors that will allow subjects to achieve acceptable levels of urge reduction. Comparisons were made to evaluate differences between blu™ formulations as well as to the market-leading conventional cigarette, Marlboro Gold King Size ("Marlboro cigarette').
详细描述
This was a randomized, partially single-blinded, 6-period crossover study of 24 subjects.
The primary objectives of this study were to:
- characterize the rate and extent of nicotine exposure following a single controlled administration and ad lib use of blu™ e-cigarettes,
- characterize smoking urge following a single controlled administration and ad lib use of blu™ e cigarettes.
The secondary objectives of this study were to:
- Compare the pharmacokinetic (PK) profile of nicotine between selected blu™ formulations and between the blu™ products and Marlboro cigarettes following a single controlled administration and ad lib use of each study product.
- Compare changes in smoking urge within and between selected blu™ formulations and between the blu™ products and Marlboro cigarettes following a single controlled administration and ad lib use of each study product.
- Compare the changes in exhaled carbon monoxide (CO) within and between selected blu™ formulations and between the blu™ products and Marlboro cigarettes following use of each study product.
- Assess the tolerability of each study product following short-term use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
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 and female smokers
- •21 to 65 years of age, inclusive, at Screening.
- •Smoker for at least 12 months prior to Check-in
- •Currently smoked an average of 10 or more manufactured cigarettes per day (no restriction on brand-style, king size [ approx. 83 - 85 mm] and 100s [approximately 98 - 100 mm] only)
- •A history of e-cigarette use was allowed.
- •Females of childbearing potential agreed to use a PI-approved method of contraception
排除标准
- •Use of tobacco- or nicotine-containing products other than manufactured cigarettes and e-cigarettes (e.g., roll-your-own cigarettes, bidis, snuff, snus, tablets, inhalers, pipes, cigars, chewing tobacco, nicotine replacement therapies [e.g., gum, patches, lozenges, nasal spray, or inhalers]) within 28 days prior to Day 1 product administration or during the study.
- •Use of any prescription smoking cessation treatments, including, but not limited to, varenicline (Chantix®) or buproprion (Zyban®) within 3 months prior to Day 1 product administration and throughout the study.
- •Known hypersensitivity to menthol, glycerol, or propylene glycol (PG).
- •Exhaled CO ≤ 10 ppm at Screening.
- •Self-reported puffers (i.e., smokers who draw smoke from the cigarette into the mouth and throat but do not inhale).
- •Use of medications known to interact with cytochrome P450 2A6 (including, but not limited to, amiodarone, desipramine, isoniazid, ketoconazole, miconazole, phenobarbital, rifampin, tranylcypromine, and methoxsalen) within 3 months prior to Day 1 product administration.
- •History of drug or alcohol abuse within 24 months of Day 1 product administration
- •Female subjects who were pregnant, lactating, or intended to become pregnant from Screening through completion of study.
结局指标
主要结局
Profile nicotine pharmacokinetics following use of e-cigs and regular cigarettes
时间窗: 6 months
Measure plasma nicotine PK outcome measures such as Peak Plasma Concentration and Area under the Plasma Concentration versus time curve.
次要结局
- Assess smoking urge scores on the Visual Analog Scale following use of electronic and regular cigarettes(6 months)