NCT06619964Enrolling By Invitation不适用
Developing Evidence to Inform Regulatory Policy on Nicotine Content in E-Liquids
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
- 否
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
Risa Robinson
Professor
Rochester Institute of Technology
研究点 (1)
Loading locations...
相似试验
已完成
不适用
E-Cigarettes: Dynamic Patterns of Use and Health EffectsSmokingNicotine DependenceNCT02527980University of Wisconsin, Madison422
终止
不适用
Investigation of the Effects of Electronic Cigarettes on Vascular HealthVascular HealthNCT03041493Memorial Sloan Kettering Cancer Center12
撤回
不适用
Understanding Factors That Influence Electronic Cigarette Nicotine Delivery Through PET Imaging of Beta-2 Nicotinic Acetylcholine ReceptorsElectronic Cigarette UseNCT04258852Yale University
已完成
不适用
Baby Albert: Electronic Cigarette Pharmacokinetics (PK) and Abuse LiabilityTobacco UseNCT03637452University of Oklahoma19
撤回
不适用
Cigarette Harm Reduction With Electronic Cigarette UseNicotine DependenceTobacco ToxicityNicotine Dependence, CigarettesCardiovascular Risk FactorNicotine WithdrawalNCT03473483University of California, San Francisco
