Nicotine Vapor Specific Sensory Measurement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Sensory response measures
研究概览
简要总结
This trial aims to develop reliable and valid measures of sensory experiences unique to e-cigarette use. Regardless of whether flavorings show evidence of toxicity in a biological sense, they may nonetheless increase harm by other means, such as increasing appeal, decreasing risk perceptions, or masking harshness or irritation that might lead users to discontinue use.
详细描述
PRIMARY OBJECTIVE:
I. Study that flavors might be related to the phenomenon of 'indirect' toxicity.
OUTLINE: Participants are randomized to 1 of 2 conditions.
CONDITION I: Participants attend up to 3 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on 3 randomly assigned conditions (combinations of carrier and nicotine concentrations).
CONDITION II: Participants attend up to 2 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on a nicotine-free condition and 3 randomly assigned conditions (combinations of carrier concentration and nicotine form).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 vapers of products containing nicotine
- •No concurrent use of other tobacco products
- •Self reported general good health
- •No allergies - specifically known active untreated seasonal allergies that would interfere with smell or taste procedures
- •No self-reported taste or smell deficits
- •Not pregnant or lactating
- •No medications known to interfere with taste/smell (i.e.: certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc)
- •Passing scores on the phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests
- •Access to video-conference or telephone
- •Ability to store test products in a secure location away from children
排除标准
- •Not current daily vapers
- •Concurrent use of other tobacco products
- •Self-reported fair or poor general health
- •Allergies - active untreated seasonal allergies that would interfere with smell or taste procedures
- •Self-reported taste or smell deficits
- •Pregnant or lactating
- •Medications known to interfere with taste/smell (i.e.: certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc)
- •Failing scores on the phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests
- •No access to video-conference or telephone
- •Unable to store test products in a secure location away from children
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
- •Adults unable to consent
- •Adults unable to legally purchase tobacco products in New York (NY) state (18-20)
结局指标
主要结局
Sensory response measures
时间窗: 2 years
Will be assessed by product evaluation scale - Scale consists of 22 questions with #1 = Not at all - 7 = Extremely
Sensory response measure
时间窗: 2 years
gMLS rating of harshness, throat hit, and pleasantness.
次要结局
未报告次要终点