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临床试验/NCT04262817
NCT04262817已完成1 期

The Interaction of Flavor With Nicotine Form in Adult Smokers

Yale University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Changes in Liking of E-cigarette Overall

研究概览

简要总结

This study seeks to elucidate the impact of e-cigarette flavor on subjective effects and nicotine exposure from e-cigarettes containing different forms of nicotine.

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, Care Provider)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 21 years old, able to read and write, use of combustible

排除标准

  • 未提供

研究组 & 干预措施

E-cigarette flavor

Experimental

In this arm, participants will receive two experimental e-cigarette flavors

干预措施: Nicotine form (Drug)

E-cigarette flavor

Experimental

In this arm, participants will receive two experimental e-cigarette flavors

干预措施: E-cigarette experimental flavor (Other)

E-cigarette nicotine form

Experimental

In this arm, participants will receive two forms of nicotine in an e-cigarette

干预措施: Nicotine form (Drug)

E-cigarette nicotine form

Experimental

In this arm, participants will receive two forms of nicotine in an e-cigarette

干预措施: E-cigarette experimental flavor (Other)

结局指标

主要结局

Changes in Liking of E-cigarette Overall

时间窗: up to 3 weeks

Following each puff, each participant was assessed to determine if they liked/disliked the overall e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint.

Changes in Liking of E-cigarette Flavor

时间窗: up to 3 weeks

Following each puff, each participant was assessed to determine if they liked/disliked the flavors in the e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint.

次要结局

  • gLMS: Irritation(up to 3 weeks)
  • Number of Puffs(up to 3 weeks)
  • gLMS: Sweetness(up to 3 weeks)
  • gLMS: Coolness(up to 3 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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