Assessing pharmacokinetic and pharmacodynamic variability of Δ9-tetrahydrocannabinol delivered from vaping products with and without concurrent use of nicotine

项目总结 使用蒸发设备来管理含有Δ9的液体浓缩物的趋势越来越大- 四氢大麻酚(THC)。然而，我们对这一问题的认识和理解存在差距 新一代大麻中THC的药代动力学和药效学研究 产品。关于尼古丁蒸发的文献已经清楚地表明，蒸发的产品特征和用户 行为影响蒸发物质的PK/Pd。此外，大多数吸食大麻的消费者蒸发液体 大麻浓缩品还报告同时使用含尼古丁的蒸发产品(电子烟)。建房 关于用于建立含有尼古丁的蒸发产品的PK/PD的证据基础的策略，这 该项目将检查通过蒸发输送的含THC的液体浓缩物的PK/Pd分布 通过完成三个具体目标，有和没有共同使用尼古丁的设备：目标1是检查 蒸发产品特性和用户行为如何影响THC的PK/PD。目标1将描述 真实世界设置中的PK/PD变异性。这将通过使用流动实验室巴士来招募电流来实现 检查含有THC的液体的尿布，并检查其PK/Pd。研究参与者将使用他们自己的商业 通过他们常用的蒸发装置随手拿到了子弹。在目标2中，受控实验室范例将 用于比较蒸发液和烟熏后当量标准THC装置的PK/PD曲线 大麻。AIM 3将评估顺序给予尼古丁的蒸发液的PK/PD曲线 采用双盲、安慰剂对照、随机受试者内试验设计。这个极具创新性的 通过结合自然主义的观察主义方法，这种方法将提供比现有文献显著的优势 方法和受控实验室评估，以提供THC的PK/PD描述 蒸发液体。这些发现将与现有的大麻市场和使用大麻的消费者直接相关 这些产品。这个项目将提高我们对THC的PK/PD效应的理解，通过表征 大麻消费者使用的THC蒸发液体配方和装置的PK/PD概况，建立 这些产品相对于吸食大麻的效果差异，并提供必要的数据说明如何 联合使用烟碱和THC可能会影响PK/PD。来自该项目的数据将与 为THC蒸发产品未来的监管和消费者安全努力提供信息。

PROJECT SUMMARY There is a growing trend in the use of vaping devices used to administer liquid concentrates containing Δ9- tetrahydrocannabinol (THC). However, there is a gap in our knowledge and understanding of the pharmacokinetics (PK) and pharmacodynamics (PD) of THC delivered from this new generation of cannabis products. The literature on nicotine vaping has clearly shown that vaping product characteristics and user behaviors influence the PK/PD of vaped substances. Additionally, most cannabis consumers who vape liquid cannabis concentrates also report concurrent use of nicotine-containing vaping products (e-cigarettes). Building on strategies used to establish the evidence base on the PK/PD of nicotine-containing vaping products, this project will examine the PK/PD profile of THC-containing liquid concentrates delivered through vaping devices WITH and WITHOUT co-use of nicotine through completion of three specific aims: Aim 1 is to examine how vaping product characteristics and user behaviors impact the PK/PD of THC. Aim 1 will characterize the PK/PD variability in real-world settings. This will be achieved by using a mobile laboratory bus to recruit current vapers of THC-containing liquids and examine their PK/PD. Study participants will use their own commercially obtained THC cartridges ad lib through their usual vaping device. In Aim 2, a controlled laboratory paradigm will be used to compare the PK/PD profiles of equivalent standard THC units delivered from vaping liquids vs smoked cannabis. Aim 3 will assess the PK/PD profiles of THC vaping liquids sequentially administered with nicotine using a double-blind, placebo-controlled, randomized within-subjects trial design. This highly innovative approach will offer a significant advantage over the existing literature by combining naturalistic observational methods and controlled laboratory assessments to provide a depiction of the PK/PD of THC delivered through vaping liquids. The findings will be directly relevant for the existing cannabis market and consumers who use these products. This project will improve our understanding of the PK/PD effects of THC by characterizing the PK/PD profiles of THC vaping liquid formulations and devices used by cannabis consumers, establishing differences in the effects of these products relative to smoked cannabis, and providing necessary data on how co-use of vaped nicotine and THC may impact THC PK/PD. Data from this project will be highly relevant for informing future regulatory and consumer safety efforts for THC vaping products.