Randomized Crossover Study Comparing the Pharmacokinetics and Pharmacodynamics of Two Different Nicotine Salt Concentrations and Free-base Nicotine Using an Open Vape Pod System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Nicotine Peak Plasma Concentration (Cmax)
研究概览
简要总结
Comparison of the pharmacokinetics and pharmacodynamics of two different nicotine salt concentrations and free-base nicotine using an open vape pod system
详细描述
On each study day, one puff will be taken with the assigned product every 30 seconds (total of 10 puffs). Blood samples will be collected to measure nicotine 15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff. Heart rate and blood pressure will be measured 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff. Post-use withdrawal, craving, reward, and satisfaction will be assessed 10 minutes and 1 and 3 hours after the last puff using the modified Minnesota Nicotine Withdrawal Scale (MNWS), the Tiffany Questionnaire on Smoking Urges (QSU), and the Positive and Negative Affect Schedule (PANAS) questionnaires. Respiratory symptoms will be assessed at baseline and 5 minutes after the last puff. Ten minutes post-use, the direct effects of the assigned product (e.g. satisfying, calming, pleasant, vape another one right now) will also be assessed using visual analog scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Vaping of high and low concentration nicotine salt and free-base nicotine will be double-blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women, age 18 or older at screening, who have used electronic cigarettes and/or smoked at least 5 cigarettes per day in the past 30 days
- •Saliva cotinine of > 50 ng/mL at screening
- •No clinically significant findings on the physical examination at screening
- •Ability to communicate well with the investigator and to understand and comply with the requirements of the study
- •Women of child-bearing age: willingness of using a reliable contraception method during the study
- •Signed informed consent
排除标准
- •Known hypersensitivity/allergy to a content of the e-liquid
- •Pregnancy or breast feeding
- •BMI < 18 or > 28 kg/m2 at screening
- •History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening
- •Loss of ≥ 250 ml of blood within 3 months prior to screening, including blood donation
- •Treatment with an investigational drug within 30 days prior to screening
- •Treatment with prescribed or over-the-counter (OTC) medications with potential influence on CYP2A6 function within 1 week prior to screening (with the exception of contraception)
- •History or clinical evidence of any disease (e.g. gastrointestinal tract-disease) and/or existence of any surgical or medical condition, which in the opinion of the investigator might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity
- •Legal incapacity or limited legal capacity at screening
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
研究组 & 干预措施
Nicotine salt 20 mg/mL
Vaping of nicotine salt e-liquids with a nicotine concentration of 20 mg/mL.
干预措施: standardized vaping protocol (Other)
Nicotine salt 40 mg/mL
Vaping of nicotine salt e-liquids with a nicotine concentration of 40 mg/mL.
干预措施: standardized vaping protocol (Other)
Free-base nicotine 20 mg/mL
Vaping of free-base nicotine e-liquids with a nicotine concentration of 20 mg/mL.
干预措施: standardized vaping protocol (Other)
结局指标
主要结局
Nicotine Peak Plasma Concentration (Cmax)
时间窗: Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff
Comparison of nicotine Cmax between groups
次要结局
- Heart rate(15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff)
- Area under the plasma concentration versus time curve (AUC)(Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff)
- Time at which the Cmax is observed (Tmax)(Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff)
- Genotyping of the hepatic cytochrome P450 enzyme CYP2A6(Blood sample collection during first session)
- Positive and Negative Affect Schedule (PANAS)(Baseline, 10 minutes and 1 and 3 hours after the last puff)
- Respiratory symptoms(At baseline and 5 minutes after the last puff)
- Elimination half-life (t1/2)(Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff)
- Nicotine metabolite ratio (NMR)(Assessed at screening visit)
- Tiffany Questionnaire on Smoking Urges-Brief (QSU) total (global) craving score(Baseline, 10 minutes and 1 and 3 hours after the last puff)
- Modified Minnesota Nicotine Withdrawal Scale (MNWS)(Baseline, 10 minutes and 1 and 3 hours after the last puff)
- Direct effects(Ten minutes post-use)
- Systolic blood pressure(15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff)
- Diastolic blood pressure(15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff)