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临床试验/NCT04357379
NCT04357379已完成不适用

Impact Of IQOS Non-Cigarette Tobacco Product On Reinforcement Value and Use In Current Smokers

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年7月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Number of Participants Who Prefer IQOS

研究概览

简要总结

A novel type of non-cigarette tobacco product was recently approved for sale in the US, the heated tobacco product (HTP) IQOS. IQOS may be less harmful than cigarettes, and there are some reports that it may produce more rewarding subjective effects compared to e-cigarettes. The approval of IQOS provides a unique opportunity to gather preliminary data surrounding IQOS. The goal of this pilot study is to assess the subjective effects and relative reinforcement value of IQOS, including its downstream effects on cigarette smoking. Current smokers will complete a one-week baseline period where they smoke as normal before attending an in-person lab visit. During the in-person lab visit, participants (n=10) will sample a traditional cigarette and a novel IQOS tobacco product. Participants will answer questionnaires about each product they sample and then complete a preference assessment in which they choose between the IQOS and their own cigarette. Finally, participants will take home a tobacco product they sampled to use ad libitum (1-week sampling). During the at-home baseline and sampling weeks, participants will complete electronic daily diaries cataloging their tobacco use. Biomarkers (i.e., expired carbon monoxide, cotinine) will corroborate self-reported indices of use.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • daily cigarette smoker
  • interested in using non-cigarette tobacco product
  • have a smartphone that can receive text messages and has access to the internet or have an e-mail account they check daily (necessary for daily diary completion).

排除标准

  • additional tobacco use criteria
  • additional medical criteria

结局指标

主要结局

Number of Participants Who Prefer IQOS

时间窗: Lab Visit 2, occurring approximately one week after the initial screening/baseline visit

Participants complete a preference assessment in which they choose between the IQOS or a traditional cigarette in a series of trials. The outcome of this assessment is the number of participants who prefer the IQOS over a traditional cigarette

次要结局

  • Cigarettes Per Day(Week 2 of study)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tracy Smith

Assistant Professor

Medical University of South Carolina

研究点 (2)

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