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

评估同时使用或不使用尼古丁的电子烟产品释放的α9-四氢大麻酚的药代动力学和药效学变异性

• 批准号: 10569405
• 负责人: Maciej Lukasz Goniewicz
• 金额: $ 70.62万
• 依托单位: ROSWELL PARK CANCER INSTITUTE CORP
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10569405
• 关键词: Acute; Address; Appearance; Behavior; Behavior assessment; Cannabinoids; Cannabis; Characteristics; Clinical Trials Design; Data; Device Designs; Devices; Dose; Double-Blind Method; Drug Delivery Systems; Drug Kinetics; Electronic cigarette; Elements; Evaluation; Future; Generations; Goals; Heating; Human; Individual; Inhalation; Knowledge; Laboratories; Life; Liquid substance; Literature; Methods; Nicotine; Observational Study; Participant; Pharmaceutical Preparations; Pharmacodynamics; Pharmacology; Placebo Control; Population; Prevalence; Prevention; Procedures; Property; Randomized; Regulation; Reporting; Research; Risk; Safety; Self Administration; Smoke; Solvents; Speed; THC concentration; Temperature; Terpenes; Tetrahydrocannabinol; Time; United States; behavior influence; design; evidence base; experience; human data; improved; innovation; liquid formulation; marijuana use; marijuana user; marijuana vaping; nicotine use; non-cannabinoid; novel; pharmacokinetics and pharmacodynamics; randomized trial; recruit; response; trend; trial design; vaper; vaping; vaping THC; vaping nicotine

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.

项目摘要 使用用于管理含有Δ9-的液体浓缩物的蒸发装置的趋势正在增长。 四氢大麻酚（THC）。但是，我们的知识和理解存在差距 从新一代大麻中传递的THC的药代动力学（PK）和药效学（PD） 产品。关于尼古丁蒸发的文献清楚地表明，烟的产品特征和用户 行为会影响蒸气物质的PK/PD。此外，大多数vape液体的大麻消费者 大麻浓缩物还报告同时使用含尼古丁的蒸发产品（电子烟）。建筑 关于用来建立含尼古丁蒸发产品的PK/PD的证据基础的策略 项目将检查通过Vaping传递的含THC的液体浓缩物的PK/PD轮廓 通过完成三个特定目的，有或没有共同使用尼古丁的设备：目标1是检查 烟的产品特性和用户行为如何影响THC的PK/PD。 AIM 1将表征 现实世界设置中的PK/PD变异性。这将通过使用移动实验室巴士招募当前 含THC的液体的蒸气并检查其PK/PD。学习参与者将在商业上使用自己的 通过其通常的蒸气装置获得了THC墨盒的Ad lib。在AIM 2中，受控实验室范式将 用于比较从烟液与抽烟的同等标准THC单元的PK/PD轮廓 大麻。 AIM 3将评估用尼古丁依次给药的THC Vaping液体的PK/PD轮廓 使用双盲，安慰剂对照，随机的受试者内试验设计。这种高度创新的 通过结合自然主义观察，方法将比现有文献具有重要优势 方法和受控的实验室评估，以提供对通过的PK/PD的描述 蒸气液体。这些发现将与现有的大麻市场和使用的消费者直接相关 这些产品。该项目将通过表征该项目来提高我们对THC的PK/PD影响的理解 大麻消费者使用的液体配方和设备的PK/PD轮廓建立 这些产品相对于烟熏大麻的影响的差异，并提供有关如何 烟碱和THC的共同使用可能会影响thc pk/pd。该项目的数据将与 为THC Vaping产品提供未来的监管和消费者安全工作。