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临床试验/NCT03635333
NCT03635333已完成1 期

Effects of E-Cigarette Flavors on Adults

Yale University1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2019年5月14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
130
试验地点
1
主要终点
Change Score in Liking/Wanting of E-cigarette

研究概览

简要总结

This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers.

详细描述

This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers. Regular cigarette smokers who do not want to quit smoking will be asked to complete 3 lab sessions in which they will use an e-cigarette and complete questionnaires. This will be followed by a two-week period where participants are asked to stop using cigarettes and other tobacco products and to only use the e-cigarettes provided. Researchers will examine the influence of flavors (sweet, cool, tobacco) on reward (liking/wanting) from e-cigs containing one of two nicotine concentrations (6 mg/ml, 18 mg/ml) following acute tobacco abstinence.

As of October 2020, this protocol was updated in which an additional lab session was added. Participants are to complete 4 lab sessions in which they will use an e-cigarette and complete questionnaires. In each individual lab session, they will sample one of the following four e-liquids: cherry, vanilla, menthol, tobacco. Additionally, participant age range was shifted to 21-50 with the younger condition being 21-34 and older being 35-50 and cigarette requirement was at least 1 cigarette/day at this time to be more representative of current persons who smoke.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 21-34 years or 35 -50 years
  • Able to read and write
  • Smoking >/= 1 cigarettes or cigars/day
  • Willing to abstain from regular smoking for 2 weeks and use only e-cigarettes
  • Not seeking treatment to stop smoking

排除标准

  • Daily use of other drugs including prescribed psychoactive drugs
  • Any significant current medical or psychiatric condition
  • Known hypersensitivity to propylene glycol
  • Pregnant or lactating females

研究组 & 干预措施

Low nicotine, tobacco

Experimental

6 mg nicotine combined with tobacco flavored e-juice

干预措施: Nicotine (Drug)

Low nicotine, tobacco

Experimental

6 mg nicotine combined with tobacco flavored e-juice

干预措施: Flavor (Drug)

Low nicotine, menthol

Experimental

6 mg nicotine combined with menthol flavored e-juice

干预措施: Nicotine (Drug)

Low nicotine, menthol

Experimental

6 mg nicotine combined with menthol flavored e-juice

干预措施: Flavor (Drug)

Low nicotine,cherry

Experimental

6 mg nicotine combined with cherry flavored e-juice

干预措施: Nicotine (Drug)

Low nicotine,cherry

Experimental

6 mg nicotine combined with cherry flavored e-juice

干预措施: Flavor (Drug)

High nicotine, tobacco

Experimental

18 mg nicotine combined with tobacco flavored e-juice

干预措施: Nicotine (Drug)

High nicotine, tobacco

Experimental

18 mg nicotine combined with tobacco flavored e-juice

干预措施: Flavor (Drug)

High nicotine, menthol

Experimental

18 mg nicotine combined with menthol flavored e-juice

干预措施: Nicotine (Drug)

High nicotine, menthol

Experimental

18 mg nicotine combined with menthol flavored e-juice

干预措施: Flavor (Drug)

High Nicotine, cherry

Experimental

18 mg nicotine combined with cherry flavored e-juice

干预措施: Nicotine (Drug)

High Nicotine, cherry

Experimental

18 mg nicotine combined with cherry flavored e-juice

干预措施: Flavor (Drug)

Low Nicotine, Vanilla

Experimental

6 mg nicotine combined with vanilla flavored e-juice

干预措施: Nicotine (Drug)

Low Nicotine, Vanilla

Experimental

6 mg nicotine combined with vanilla flavored e-juice

干预措施: Flavor (Drug)

High Nicotine, Vanilla

Experimental

18 mg nicotine combined with vanilla flavored e-juice

干预措施: Nicotine (Drug)

High Nicotine, Vanilla

Experimental

18 mg nicotine combined with vanilla flavored e-juice

干预措施: Flavor (Drug)

结局指标

主要结局

Change Score in Liking/Wanting of E-cigarette

时间窗: Baseline (+10 minutes) to end of lab session (+40 minutes)

The Labeled Hedonic Scale (LHS; Lim et al., 2009) will be used to ask about liking and wanting of the e-cigarette (one item VAS scale \[range -100 to 100\] with ratings from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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