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临床试验/NCT04399031
NCT04399031已完成不适用

Effects of e-Cigarettes on Perceptions and Behavior - Substudy 1

University of Southern California1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2019年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
124
试验地点
1
主要终点
Subjective Appeal

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 in the overall population of tobacco product users as well as affect product appeal across young adult e-cigarette users and middle-age/older adult smokers; (2) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile. For this substudy, young adult vapers (N=100) and adult smokers (N=100) 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, nicotine formulation).

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, Outcomes Assessor)

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

  • Vapers/E-cigarette Users
  • E-cigarette/vaping device use at least three days per week for at least 2 months
  • Regular use of e-cigarettes/vaping devices containing nicotine
  • Cigarette Smokers
  • Daily cigarette smoking for at least two years
  • Currently smoke at least four cigarettes per day
  • Interested in trying an e-cigarette or current use of an e-cigarette

排除标准

  • Vapers/E-cigarette Users
  • Pregnant or breastfeeding
  • Desire to cut down on use of e-cigarette/vaping device
  • Cigarette Smokers
  • Pregnant or breastfeeding
  • Current daily use of other combustible tobacco products (such as cigars)

研究组 & 干预措施

E-cigarette e-liquid 1

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 2

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 3

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 4

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 5

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 6

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 7

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 8

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 9

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 10

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 11

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 12

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 13

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 14

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 15

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 16

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 17

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 18

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 19

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

E-cigarette e-liquid 20

Experimental

Participants will self-administer an e-cigarette e-liquid.

干预措施: E-cigarette e-liquid (Drug)

结局指标

主要结局

Subjective Appeal

时间窗: 1 hour

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

Sensory Appeal

时间窗: 1 hour

Self-report measures of product appeal will be completed following e-cigarette self-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 (1)

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