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临床试验/NCT03742817
NCT03742817已完成不适用

Effects of e-Cigarettes on Perceptions and Behavior

University of Southern California2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年2月1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
45
试验地点
2
主要终点
Questionnaire of Vaping Urges

研究概览

简要总结

This project will assess the ways in which e-cigarette product diversity impacts the user experience to inform potential regulations by identifying product characteristics that may: (1) put young adults at risk for tobacco product use; and (2) facilitate adult smokers switching to e-cigarettes. There are three primary objectives to the study: (1) Determine which dimensions of e-cigarette product diversity differentially affect product appeal across young adult e-cigarette users and middle-age/older adult smokers with an interest in, but no significant experience with, e-cigarettes; (2) Determine which dimensions of e-cigarette product diversity differentially affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers with an interest in, but no significant experience with, e-cigarettes; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile. For Aim 1, young adult vapers (N=200) and adult smokers (N=200) will attend one laboratory session in which they will self-administer e-cigarette products varied according to within-subject e-cigarette factors (e.g., flavor, pg/vg ratio). For Aim 2, young adults vapers (N=360) and adult smokers (N=360) will administer an e-cigarette product and complete behavioral economic tasks that test the participant's choice of earning money to delay initiation and continued use of: (1) The sampled e-cigarette product (abuse liability; young adult vapers); or (2) Their own brand cigarettes (ability to resist smoking; adult current smokers). A pilot study will establish device and e-liquid parameters (e.g., nicotine concentration) to be used for all aims.

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
Single (Participant)

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

  • E-cigarette use >3 day/week for >2 months
  • Report regularly using e-cigarette products with nicotine
  • Positive cotinine test via NicAlert test strip
  • Daily cigarette smoking for ≥ 2 years
  • Currently smoke > 4 cig/day
  • Interest in trying an e-cigarette or current use of e-cigarettes

排除标准

  • Pregnancy/breastfeeding
  • Desire to immediately reduce e-cigarette use
  • Breath CO < 9ppm at intake
  • Pregnancy / breastfeeding
  • Current daily use of other combustible tobacco products (e.g., cigars)

结局指标

主要结局

Questionnaire of Vaping Urges

时间窗: 4 hours

10-item Brief Questionnaire of Vaping Urges will assess desire, intention, urge and need to vape e-cigarettes.

Positive Affect Negative Affect Schedule

时间窗: 4 hours

The 10-item Positive Affect Negative Affect Schedule (PANAS-SF) will be used to measure positive and negative affect.

Subjective Appeal

时间窗: 1 hour

Self-report measures of product appeal will be completed following the e-cigarette administration.

次要结局

未报告次要终点

研究者

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

Adam Leventhal

Professor of Preventive Medicine

University of Southern California

研究点 (2)

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