Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Puff Topography: Puff Count
研究概览
简要总结
This clinical trial tests the effect of tobacco flavor and liquid composition on the way a person puffs on a vape (topography). In general, tobacco products are designed with sensory factors in mind, such as flavor, to increase the appeal. Flavors and the composition of nicotine, either made in a lab (synthetic) or from tobacco, may create positive sensory effects, such as look, feel and taste, and influence smoking behavior and willingness to try different types of cigarettes. Understanding how nicotine vaping products are used is important in assessing individual and population level health risks. Vape flavors and synthetic nicotine may be related to harmful effects on health from vaping and may impact the appeal, risk beliefs and vaping topography.
详细描述
PRIMARY OBJECTIVE:
- Examine the influence of tobacco flavoring composition on vaping topography.
- Examine the influence of synthetic versus (vs.) tobacco derived nicotine on vaping topography.
SECONDARY OBJECTIVE:
- Examine the influence of tobacco flavoring composition on vaping topography.
- Examine the influence of synthetic versus (vs.) tobacco derived nicotine on vaping topography.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 vapers of products containing nicotine
- •No daily concurrent use of other tobacco products
- •Self-reported general good health
- •Women of child bearing potential must be willing to provide a urine sample and test negative prior to receiving any study-related products/procedures
- •Ability to speak, read, and write in English
- •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 procedure
排除标准
- •Allergies - active untreated seasonal allergies that would interfere with smell or taste procedures
- •Self-reported taste or smell deficits
- •Pregnant or nursing female participants
- •Medications known to interfere with taste/smell (i.e., certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc)
- •Unwilling to use open system vaping device in laboratory setting
- •Positive diagnosis of human coronavirus 2019 infection (COVID-19) within 10 days prior to start of study intervention
- •Unwilling or unable to follow protocol requirements
- •Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive the study intervention
结局指标
主要结局
Puff Topography: Puff Count
时间窗: Single Session, Approximately 2 hours in duration
Measure of vaping topography counting total number of puffs.
Puff Topography: Puff Duration (in Seconds)
时间窗: Single Session, Approximately 2 hours in duration
Measure of vaping topography counting duration of puffs in seconds.
Puff Topography: Inter Puff Interval (IPI)
时间窗: Single Session, Approximately 2 hours in duration
Measure of vaping topography counting the interval between puffs in seconds.
Puff Topography: Flow Rate
时间窗: Single Session, Approximately 2 hours in duration
Measure of vaping topography measuring the rate of flow per puff in milliliters per second.
Puff Topography: Puff Volume
时间窗: Single Session, Approximately 2 hours in duration
Measure of vaping topography measuring the volume per puff in ml.
次要结局
- Subjective Questionnaires of Product Evaluation(Single Session, Approximately 2 hours in duration)