Sex Differences in E-Cigarette Flavor Sensory Perception As It Relates to Appeal and Reinforcing Efficacy Among Adult Smokers: Study 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Reinforcing Efficacy
研究概览
简要总结
The primary objective is to examine the influence of sex on sensory effects, appeal, and reinforcing value of nicotine containing e-cigs in popular flavor components; sweet and cooling.
详细描述
This study looks at the effect of sex on the sensory effects of flavor components in e-cigarettes. Regular combustible tobacco users will sample 3 different flavored e-cigarettes containing nicotine in a human lab paradigm.
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 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21-44 years old
- •Able to read/write
- •Current cigarette smoking
- •Recent E-cig Exposure (>/= 10 uses in past 6 mo.)
- •Urine cot >200ng/ml
- •Willing to abstain from nicotine/tobacco 6-8hrs prior to lab session
- •Not looking to quit
排除标准
- •Untreated chronic medical conditions
- •Non-stable Rx medication
- •Illicit drug use
- •Pregnant, trying to become pregnant, breastfeeding
- •Not fully vaccinated for Coronavirus (e.g. COVID-19)
研究组 & 干预措施
Experimental E-Liquid Order "A"
All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits).
干预措施: E-liquid Flavor 1 (Other)
Experimental E-Liquid Order "A"
All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits).
干预措施: E-liquid Flavor 2 (Other)
Experimental E-Liquid Order "A"
All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits).
干预措施: E-liquid Flavor 3 (Other)
Experimental E-Liquid Order "B"
All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits).
干预措施: E-liquid Flavor 1 (Other)
Experimental E-Liquid Order "B"
All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits).
干预措施: E-liquid Flavor 2 (Other)
Experimental E-Liquid Order "B"
All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits).
干预措施: E-liquid Flavor 3 (Other)
Experimental E-Liquid Order "C"
All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits).
干预措施: E-liquid Flavor 1 (Other)
Experimental E-Liquid Order "C"
All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits).
干预措施: E-liquid Flavor 2 (Other)
Experimental E-Liquid Order "C"
All participants will be given all e-liquids (i.e. 3 flavor conditions all containing nicotine) in this within subject cross-over design study. Participants will be randomized in the order in which they receive the flavor conditions (across 3 visits).
干预措施: E-liquid Flavor 3 (Other)
结局指标
主要结局
Reinforcing Efficacy
时间窗: immediately after intervention, up to 15 minutes
Change in reinforcing value at each flavor. Participants will use the multiple choice procedure to self-report their responses using a computer mouse to indicate where on the scale response falls. Following each puffing bout, participants will be asked to make discrete hypothetical choices between 10-puffs of the e-cig they had just used or a series of 44 monetary values ($0.25-$15.06). The minimum monetary value at which money is chosen over the e-cig puffs is a contingency-based estimate of e-cig value. At the end of each lab session, participants will be given a choice between another 10 e-cig puffs or one of the monetary amounts they picked in the Multiple Choice Procedures completed earlier.
Appeal
时间窗: immediately after intervention, up to 15 minutes
Change in appeal at each flavor 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) to 100 (most liked), with 'neither liked nor disliked' as midpoint.
Sensory Effects
时间窗: immediately after intervention, up to 15 minutes
Change in sweetness, coolness, irritation, and bitterness at each flavor 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).
次要结局
未报告次要终点