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: 10707183
• 负责人: Maciej Lukasz Goniewicz
• 金额: $ 69.67万
• 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/10707183
• 关键词: Acute; Appearance; Behavior; Behavior assessment; Cannabinoids; Cannabis; Cannabis retail; 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; United States; behavior influence; design; evidence base; experience; human data; improved; innovation; laboratory experiment; 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 在使用用于施用含有Δ9-Δ 10的液体浓缩物的电子烟装置方面存在增长的趋势。 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。 新一代大麻释放的THC的药代动力学（PK）和药效学（PD） 产品.关于尼古丁蒸汽烟的文献清楚地表明，蒸汽烟产品特性和用户 行为影响雾化物质的PK/PD。此外，大多数吸食液体的大麻消费者 大麻浓缩物还报告同时使用含尼古丁的电子烟产品（电子烟）。建筑 关于用于建立含尼古丁电子烟产品PK/PD证据基础的策略， 该项目将检查通过电子烟输送的含THC液体浓缩物的PK/PD特征 通过完成三个具体目标，使用和不使用尼古丁的器械：目标1是检查 电子烟产品特性和用户行为如何影响THC的PK/PD。目标1将描述 真实世界环境中的PK/PD变异性。这将通过使用移动的实验室总线来招募电流来实现 含四氢大麻酚的液体的vapers和检查他们的PK/PD。研究参与者将使用自己的商业 通过他们常用的电子烟装置随意获得THC盒。在目标2中，受控实验室范例将 用于比较从电子烟液体与吸烟递送的等效标准THC单位的PK/PD特征 大麻目标3将评估与尼古丁顺序施用的THC电子烟液体的PK/PD特征 采用双盲、安慰剂对照、随机受试者内试验设计。这种高度创新的 方法将提供一个显着的优势，现有的文献相结合的自然观察 方法和对照实验室评估，以描述通过以下途径递送的THC的PK/PD 电子烟液体调查结果将直接关系到现有的大麻市场和消费者谁使用 这些产品该项目将通过表征THC的PK/PD效应， 大麻消费者使用的THC蒸汽液体制剂和装置的PK/PD特征， 这些产品相对于吸食大麻的影响的差异，并提供必要的数据， 同时使用尼古丁和THC可能会影响THC的PK/PD。该项目的数据将高度相关， 为THC vaping产品的未来监管和消费者安全工作提供信息。