NCT05030194已完成不适用
Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study]
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in sensory response
研究概览
简要总结
To pilot test the appeal of non-tobacco oral nicotine products in cigarette smokers, smokeless tobacco users, and oral nicotine users.
详细描述
This study will assess the use, nicotine delivery, subjective response, and sensory appeal of an oral nicotine product (ZYN) compared to electronic nicotine delivery systems (ENDS, Vuse Alto) in cigarette smokers, smokeless tobacco users and oral nicotine users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current daily cigarette smoker as determined by:
- •Smokes >5 cigarettes/day for >1 year OR
- •Current daily smokeless tobacco or oral nicotine user as determined by:
- •a. Uses >=5 units/day for >=1 year
- •b. Uses portioned moist snuff, loose moist snuff and/or nicotine patches
- •Willingness to abstain from using cigarettes/ST (smokeless tobacco) for 8-10 hours (overnight abstinence) prior to study visits (verified by exhaled-air carbon monoxide < 10ppm).
- •Self-report fair or better physical health.
- •Self-report fair or better mental health.
- •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related products
排除标准
- •Currently uses other tobacco or nicotine products (e.g., ENDS) > 2 days/week.
- •Self-report having active, untreated medical/psychiatric conditions History of serious side effects from nicotine or from any nicotine replacement therapies.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Nursing female participants.
- •Vulnerable populations, such as cognitively impaired adults, individuals who are not yet adults, pregnant women, and prisoners.
- •Unwilling or unable to follow protocol requirements.
- •Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.
- •Previous use of the study products (ZYN or Vuse Alto; on! or General Slims).
结局指标
主要结局
Change in sensory response
时间窗: up to 1 year
will be measured by a Questionnaire scored on a 0-100 visual analog scale with 0 (Not at all) to 100 (Extremely).
Change in nicotine boost
时间窗: up to week 4
will be measured as the post bout plasma nicotine concentration minus the pre-bout plasma nicotine concentration
次要结局
- Change is stress markers(Up to 4 weeks)
研究者
研究点 (2)
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