Determination of Liquid Flavor and Nicotine Form Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Challenge paradigm latency
研究概览
简要总结
The purpose of this research study is to find out how different types of electronic cigarette/vape e-liquids with differing sweetness and forms of nicotine affect blood nicotine levels, use behavior (how people puff), and how people feel.
详细描述
In this study, participants will be asked to do the following:
- After an initial screening visit, visit the Center for the Study of Tobacco Products 4 more times for approximately 3-hour study visits.
- Before each visit, abstain from all tobacco products (cigarettes, e-cigarettes/vapes, cigars, and hookah/waterpipe) for at least 12 hours.
- Allow researcher to take blood pressure readings (with blood pressure cuff on their arm) monitor their heart rate (with a device that attaches to their finger), and allow a nurse to insert an IV catheter into their arm that will stay there for the entire session. This catheter will be used to draw blood periodically (less than 1 tablespoon per sample, 5 samples per visit).
- During each session, participants will respond to several questionnaires to measure how they feel before and after they use an e-cigarette.
- In each session, use an electronic cigarette provided by the study team at two separate times. After using the e-cigarette two times, participants will be offered the opportunity to use their own e-cigarette or cigarette.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy (determined by self-report)
- •between the ages of 18-65
- •willing to provide informed consent
- •use cigarettes, e-cigarettes, or both
- •able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol
排除标准
- •women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening
- •existence of any condition contraindicated for this study protocol as determined by study leadership
- •Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
研究组 & 干预措施
Cigarette and/or e-Cigarette users
Each participant will participate in 4 sessions. During each session, participants will first complete a 10-puff product use period with the ECIG assigned for that session, then a 30-minute ad lib product use period, and then a cigarette/e-cigarette challenge paradigm.
干预措施: E-cigarette with sweetness type 1 and pronation level 1 (Other)
Cigarette and/or e-Cigarette users
Each participant will participate in 4 sessions. During each session, participants will first complete a 10-puff product use period with the ECIG assigned for that session, then a 30-minute ad lib product use period, and then a cigarette/e-cigarette challenge paradigm.
干预措施: E-cigarette with sweetness type 1 and pronation level 2 (Other)
Cigarette and/or e-Cigarette users
Each participant will participate in 4 sessions. During each session, participants will first complete a 10-puff product use period with the ECIG assigned for that session, then a 30-minute ad lib product use period, and then a cigarette/e-cigarette challenge paradigm.
干预措施: E-cigarette with sweetness type 2 and pronation level 1 (Other)
Cigarette and/or e-Cigarette users
Each participant will participate in 4 sessions. During each session, participants will first complete a 10-puff product use period with the ECIG assigned for that session, then a 30-minute ad lib product use period, and then a cigarette/e-cigarette challenge paradigm.
干预措施: E-cigarette with sweetness type 2 and pronation level 2 (Other)
结局指标
主要结局
Challenge paradigm latency
时间窗: at the end of the challenge paradigm, approx. 165 min
The cigarette or own brand e-cigarette challenge paradigm involves giving participants a five minute period to use their own brand cigarette or e-cigarette. Researchers measure the time it takes for the participant to pick up the product.
Challenge paradigm puffs
时间窗: at the end of the challenge paradigm, approx. 165 min
The cigarette or own brand e-cigarette challenge paradigm involves giving participants a five minute period to use their own brand cigarette or e-cigarette. Researchers measure the number of puffs the participant takes.
Change in plasma nicotine concentration
时间窗: Baseline (approx 90 min after session start) to after final product usage (up to 165 min)
Blood will be taken multiple times in each session to examine changes in plasma nicotine concentration from baseline to after various e-cigarette or cigarette usage.
Puff volume
时间窗: Through the final product use (up to 165 min)
The volume of each puff, in ml, averaged over each product use bout.
Puff duration
时间窗: Through the final product use (up to 165 min)
The duration of each puff, in ml, averaged over each product use bout.
次要结局
未报告次要终点