A Randomized, Parallel-group Open-label Trial of ENDS Users Switching From Flavors of Potentially High-toxicity Profile to Flavors of Potentially Low-toxicity Profile (CRoFT_3.2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Respiratory tract inflammation activity
研究概览
简要总结
This is a randomized, parallel-group open-label trial to evaluate respiratory symptoms in ENDS users switching from banned flavors to a non-banned flavor (tobacco) or 'tobacco free' nicotine pouches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ENDS users as determined by: (a) using banned flavored ENDS with nicotine such as fruit, candy, dessert flavors, and/or any product that indicates such flavors (b) using ENDS daily, regularly for the past 6 months (self-reported).
- •No smoking tobacco or using smokeless tobacco for the past 6 months.
- •Subjects should be free of acute respiratory illness within the proceeding 30 days prior to recruitment (self-reported).
- •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
- •After receiving information regarding the NYS flavor ban individuals must not want to quit vaping or stop using their flavored product for the next 90 days.
排除标准
- •Individuals with health conditions and therapies that may affect immune responses and levels of inflammatory markers, including allergic rhinitis, aspirin/NSAID therapy, asthma, immunodeficiency (HIV or other), Guillain-Barre Syndrome, COPD, or fever/respiratory illness within 30 days prior to entry into study (self-reported).
- •Pregnant or nursing female participants (self-reported on telephone screener, pregnancy test on Visit#1)
- •Unable to communicate in English.
- •Unable or unwilling to follow protocol requirements.
- •Self-report having active, untreated medical/psychiatric conditions.
- •History of serious side effects from nicotine or from any nicotine replacement therapies.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Vulnerable populations, such as cognitively impaired adults, individuals who are not yet adults, pregnant women, and prisoners.
- •Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.
- •After receiving information about the NYS flavor ban, participants who report that they are thinking about quitting or stop using their flavor within the next 90 days.
研究组 & 干预措施
Use Own Brand of Flavored Product
Participants will use their current flavor of e cigarettes for 90 days
干预措施: E-cigarette Flavor (Other)
Use Provided Tobacco Flavor
Participants will use a new assigned flavor for 90 days
干预措施: E-cigarette Flavor (Other)
Vaping Abstinence - use "Tobacco Free" Nicotine Pouches
Participants will be asked to stop vaping for 90 days and instead only use the provided 'tobacco free' nicotine pouches.
干预措施: Tobacco Free Nicotine Pouch (Other)
结局指标
主要结局
Respiratory tract inflammation activity
时间窗: Up to 90 days
Exhaled Nitric Oxide (FeNo)l be measured in participants' breath using a FDA cleared monitor NIOX VERO (Aerocrine) according to ATS guidelines. FeNO has been used to monitor airway inflammation to account for persistent and/or high allergen exposure as a factor associated with higher levels of FeNO
Risk biomarkers of inflammation and oxidative stress as measured by ELISA
时间窗: Up to 90 days
Oxidative stress and inflammation in plasma using ELISA . A quantitative measure of expression (units:pg/mg) will be produced.
次要结局
- Amount of recent flavored product use(UP to 90 days)
- Frequency of flavored product use(Up to 90 days)
- Flavor Preference questionnaire(Up to 90 days)