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临床试验/NCT01714778
NCT01714778已完成不适用

Electronic Cigarettes: Potential Toxicant (Acrolein) and Nicotine Delivery in Users

Queen Mary University of London1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Change in urinary 3HPMA levels after 4 weeks use of electronic cigarettes.

研究概览

简要总结

Electronic cigarettes or "e-cigarettes" (EC) may have a potential public health benefit as a safer alternative to smoking and possibly also as an aid in tobacco dependence treatment. However, there are concerns about their safety and whether they can deliver nicotine consistently and in doses necessary for such effects.

To be able to consider the safety of ECs and their potential in harm reduction, data are needed comparing the exposure to the potential toxicant, acrolein, in smokers of conventional cigarettes, users of EC, and people who use both products at the same time.

To accurately assess EC nicotine delivery, data are needed from people who use them regularly, as there is some evidence of higher and faster nicotine absorption in experienced users compared with naïve users who try them once in an artificial laboratory setting.

This study will provide information on both of these issues. Forty smokers will be given EC to use, in addition to behavioural support, as part of a stop smoking attempt. Levels of acrolein and nicotine will be measured before and after 4 weeks of EC use.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Smokers who want help in quitting
  • Aged 18 or over

排除标准

  • Women who are pregnant or breastfeeding
  • People with any current serious illness

结局指标

主要结局

Change in urinary 3HPMA levels after 4 weeks use of electronic cigarettes.

时间窗: 4 weeks

Change in urinary 3HPMA levels (a metabolite of acrolein) after 4 weeks use of electronic cigarettes, in both individuals who have stopped smoking conventional cigarettes and those who are still using them.

次要结局

  • Change in nicotine levels after 4 weeks use of electronic cigarettes (EC)(4 weeks)
  • Use of electronic cigarettes(6 months)
  • Electronic cigarette acceptability(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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