Water Content In E-Liquids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Irritation/Harshness
研究概览
简要总结
This study looks at the effect of manipulating the water concentration of certain e-liquids on sensory perception.
详细描述
This study looks at the effect of manipulating water concentration on e-cigarettes that contain aldehyde flavor chemicals on sensory perception. Regular e-cigarette users will be asked to complete 2 lab sessions in which they will sample 4 nicotine containing e-liquids. Each e-liquid will be sampled in four water concentration manipulations. Researchers will examine influence of flavor and water concentrations on sensory experience including appeal/liking and irritation and harshness.
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
- Double (Participant, Investigator)
盲法说明
Double blind, both participant and investigator will be blind to e-liquid being administered
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least 21 years old
- •able to read/write
- •>/= 6 mths e-cig use
- •regular e-cig use (>/= 4 days/week)
- •use of flavored e-cigs
- •use of nicotine containing e-cigs
- •urine cotinine >/= 200ng/ml
- •no plan to quit e-cig use
排除标准
- •breastfeeding, pregnant, trying to become pregnant
- •Medical conditions that increase risk of respiratory problems among participants
- •Current use of illegal substances
- •Medical conditions increasing risk of respiratory problems in nonpatient populations
- •Current diagnosis of an untreated psychiatric condition
- •Not fully vaccinated for Coronavirus-19
研究组 & 干预措施
Experimental E-Liquid Order "C"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
干预措施: Water Concentration 3 (Other)
Experimental E-Liquid Order "A"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
干预措施: Water Concentration 1 (Other)
Experimental E-Liquid Order "A"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
干预措施: Water Concentration 2 (Other)
Experimental E-Liquid Order "A"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
干预措施: Water Concentration 3 (Other)
Experimental E-Liquid Order "A"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
干预措施: Water Concentration 4 (Other)
Experimental E-Liquid Order "B"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
干预措施: Water Concentration 1 (Other)
Experimental E-Liquid Order "B"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
干预措施: Water Concentration 2 (Other)
Experimental E-Liquid Order "B"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
干预措施: Water Concentration 3 (Other)
Experimental E-Liquid Order "B"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
干预措施: Water Concentration 4 (Other)
Experimental E-Liquid Order "C"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
干预措施: Water Concentration 1 (Other)
Experimental E-Liquid Order "C"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
干预措施: Water Concentration 2 (Other)
Experimental E-Liquid Order "C"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
干预措施: Water Concentration 4 (Other)
Experimental E-Liquid Order "D"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
干预措施: Water Concentration 1 (Other)
Experimental E-Liquid Order "D"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
干预措施: Water Concentration 2 (Other)
Experimental E-Liquid Order "D"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
干预措施: Water Concentration 3 (Other)
Experimental E-Liquid Order "D"
All participants will be given all e-liquids (i.e. all 16 flavor*water concentration combinations (4 flavors and four water concentrations)) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across the 2 visits). For each flavor condition, water order will be randomized.
干预措施: Water Concentration 4 (Other)
结局指标
主要结局
Irritation/Harshness
时间窗: immediately after intervention, up to 15 minutes
Change in irritation at each water level as measured by the computerized Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. The Generalized Labeled Magnitude Scales (gLMS) are category ratio scales with seven semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically as per empirically determined semantic magnitudes on a 0-100 scale (strongest imaginable at the 100 end).
Appeal Assessed Using the Labeled Hedonic Scale (LHS) Ranging From -100 to 100
时间窗: immediately after intervention, up to 15 minutes
Change in appeal at each water level as measured by the computerized Labeled Hedonic Scale (LHS). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. The Labeled Hedonic Scale (LHS) is a bipolar category ratio scale that ranges from -100 (most disliked, minimum score) to 100 (most liked, maximum score), with 'neither liked nor disliked' as midpoint (0). Scores range from -100 (minimum) to 100 (maximum). Negative scores indicate dislike (lack of appeal) and positive scores indicate liking (appeal).
Appeal Assessed Using the Drug Effects Questionnaire (DEQ)
时间窗: immediately after intervention, up to 15 minutes
Change in appeal at each water level as measured by the computerized version of the Drug Effects Questionnaire (DEQ). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. A modified version of the Drug Effects Questionnaire (DEQ) will be used in which participants rate acute responses to the e-cigarette on a 0-100mm scale from "not at all" (0mm) to "extremely" (100mm).
次要结局
未报告次要终点