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临床试验/NCT06619964
NCT06619964Enrolling By Invitation不适用

Developing Evidence to Inform Regulatory Policy on Nicotine Content in E-Liquids

Rochester Institute of Technology1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
120
试验地点
1
主要终点
Mean daily salivary cotinine

研究概览

简要总结

The goal of this observational study is to learn if electronic cigarette users who currently choose to use lower nicotine eliquids have reduced harm compared those who choose higher nicotine eliquids.

The main questions it aims to answer are:

  • Do lower nicotine users actually consume less nicotine compared to higher nicotine users?
  • Do lower nicotine users have lower amounts of harmful and potentially harmful constituent exposures compared to higher nicotine users?
  • Do lower nicotine users perceive their choice of product to be less harmful than higher nicotine products? Researchers will monitor ecig users of different nicotine concentrations for two weeks in their natural environment to determine how much eliquid and nicotine they consumed, assess their daily mood and craving, and measure exposure and health effect.

Participants will:

  • Complete surveys on history of tobacco use, nicotine dependence and perception.
  • Use their electronic cigarette with their usual nicotine eliquid ad lib for two weeks in their natural environment.
  • Complete daily questionnaires for mood and craving for two weeks in their natural environment.
  • Collect three salivary samples at home, morning, afternoon and evening, each day for two weeks, in their natural environment.
  • Use a topography monitor to record puffing behavior for every puff taken during week two, in their natural environment.
  • Provide saliva, urine and blood samples in the lab at the end of each week.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 21 yrs or older
  • Pod-style or pen-style users, not adjustable for power or airflow, nicotine greater than 0 mg/mL
  • Current everyday users
  • Use history of at least 30 days
  • No current use of combustible tobacco product, or nicotine replacement therapy
  • CO less than 6 ppm at intake
  • No plans to quit tobacco use in the next 30 days

排除标准

  • History of acute or chronic asthma
  • Previous diagnosis of cancer
  • Other chronic medical conditions
  • Use of chronic prescription medications
  • Pneumonia in prior six weeks
  • Upper respiratory tract infection or other febrile illness in previous 2 weeks
  • On antioxidants or anti-inflammatory therapy
  • Pregnant women or women who intend to become pregnant

结局指标

主要结局

Mean daily salivary cotinine

时间窗: From enrollment to the end of observation at 2 weeks.

Nicotine exposure as indicated by mean daily salivary cotinine will be compared for lower versus higher nicotine strength regular ecig users, on a continuous scale. This will determine the extent to which reduced nicotine products result in lower nicotine exposure.

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

Risa Robinson

Professor

Rochester Institute of Technology

研究点 (1)

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