The Impact of Cannabis Route of Administration and Co-Administration of Alcohol on Impairment

大麻给药途径和酒精联合给药对损伤的影响

• 批准号: 10292547
• 负责人: Tory Richard Spindle
• 金额: $ 69.15万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10292547
• 关键词: Accidents; Acute; Alcohol consumption; Alcoholic Intoxication; Alcohols; Attention; Automobile Driving; Behavioral; Blood; Cannabis; Cognitive; Controlled Study; Data; Detection; Development; Dose; Double-Blind Method; Drug usage; General Population; Human; Impairment; Incidence; Individual; Intoxication; Laboratories; Laboratory Study; Legal; Location; Measures; Methods; Oral; Outpatients; Participant; Performance; Persons; Pharmaceutical Preparations; Placebos; Policies; Protocols documentation; Psychomotor Impairments; Psychomotor Performance; Public Health; Questionnaires; Randomized; Research; Risk; Route; Safety; Self Administration; Smoke; Specificity; Task Performances; Time; Vaporizer; Workplace; absorption; alcohol effect; automobile accident; breath alcohol measurement; cognitive ability; cognitive function; cognitive performance; design; driving skills; driving under influence; epidemiology study; experience; field sobriety tests; impaired driving performance; improved; instrument; marijuana legalization; marijuana use; novel; performance tests; skills; tool; vapor

PROJECT SUMMARY/ABSTRACT Cannabis and alcohol are two of the most commonly used drugs in the world and are often used concurrently (i.e., “co-used”). When used independently, both cannabis and alcohol can impair psychomotor skills, attention, and cognitive functioning and ultimately, negatively impact driving performance and functioning in the workplace. Prior laboratory studies have shown that cannabis/alcohol co-use can produce additive effects on impairment, over and above impairment caused by either substance alone, and epidemiological studies show that the risk for car accidents is significantly increased when a person has used both cannabis and alcohol. Importantly, previous controlled studies on cannabis/alcohol co-use have focused almost exclusively on smoked forms of cannabis, but many novel cannabis products have emerged in recent years. In our prior laboratory studies, we have found that the acute effects of oral cannabis products (“edibles”) and cannabis vaporizers (two popular novel forms of cannabis), differ markedly from smoked cannabis. These findings suggest that oral and vaporized cannabis may interact with alcohol in distinct ways from smoked cannabis. The aim of this project is to systematically evaluate the acute impairing effects of cannabis and alcohol, when administered alone and together, in two human laboratory studies that will utilize rigorous double-blind, double- dummy, placebo-controlled designs. The studies will differ by route of cannabis administration (Study 1: oral; Study 2: vaporized), but will otherwise use essentially the same protocol. In each study, participants will complete 7 outpatient drug administration sessions in which they self-administer placebo or active cannabis (10 or 25 mg THC) and a placebo drink or alcohol drink calculated to produce a breath alcohol concentration (BAC) of 0.05%. Participants will also complete a positive control session in which they administer placebo cannabis and alcohol for a target BAC of 0.08% (the legal threshold, or “per se limit,” for driving impairment in most U.S. states). Sessions will be completed in a randomized order and separated by at least one week. Assessments will include a state-of-the-art driving simulator, a battery of cognitive/psychomotor performance tasks, field sobriety tests, and subjective drug effect questionnaires. This research can inform impairment detection standards for individuals who have co-used cannabis and alcohol (e.g., determine if 0.08% BAC is a suitable alcohol intoxication threshold if a person has also used cannabis) which can inform whether there is a need to adjust BAC per se limits in locations where cannabis is legal. Moreover, this study will evaluate a promising novel cannabis impairment detection tool (the DRUID app) which could be invaluable to public safety because current approaches to identifying cannabis impairment (e.g., per se limits for blood THC) are largely ineffective. Lastly, these findings will help guide regulatory decisions concerning the allowance of commercial establishments that sell both alcohol and cannabis as well as products that contain both alcohol and THC.

项目摘要/摘要 大麻和酒精是世界上最常用的两种药物，经常同时使用 (即“共同使用”)。单独使用时，大麻和酒精都会损害精神运动技能，注意力， 和认知功能，并最终对驾驶性能和功能产生负面影响 工作场所。先前的实验室研究表明，大麻/酒精的共同使用会对 损害，超过任何一种物质单独造成的损害，流行病学研究表明 当一个人同时使用大麻和酒精时，发生车祸的风险会显著增加。 重要的是，以前关于大麻/酒精共同使用的对照研究几乎完全集中在 大麻是吸食形式的大麻，但近年来出现了许多新的大麻产品。在我们之前的 实验室研究发现，口服大麻产品(“食用”)和大麻的急性影响 雾化器(两种流行的新型大麻)与吸烟的大麻有很大的不同。这些发现 这表明，口服和蒸发大麻可能与酒精以不同于吸烟大麻的方式相互作用。 这个项目的目的是系统地评估大麻和酒精的急性损害效应，当 单独和联合使用，在两项人体实验室研究中，将使用严格的双盲、双 虚拟的、安慰剂对照的设计。这些研究将因大麻给药途径的不同而不同(研究1：口服； 研究2：蒸发)，但在其他方面将使用基本上相同的方案。在每项研究中，参与者将 完成7次门诊药物管理课程，在这些课程中，他们自行使用安慰剂或活性大麻 (10或25毫克THC)和计算产生呼气酒精浓度的安慰剂饮料或酒精饮料 (BAC)为0.05%。参与者还将完成一次积极对照治疗，期间他们会服用安慰剂 大麻和酒精的目标BAC为0.08%(这是#年驾驶损害的法定门槛，或“本身限制” 美国大多数州)。会议将以随机顺序完成，间隔至少一周。 评估将包括一个最先进的驾驶模拟器，一组认知/精神运动表现 任务、现场清醒测试和主观药物效果问卷。这项研究可以告知减损 共同使用大麻和酒精的个人的检测标准(例如，确定0.08%的BAC是否是 适当的酒精中毒阈值，如果一个人也使用过大麻)，它可以告知是否有 在大麻合法的地区，需要调整BAC本身的限制。此外，这项研究将评估一个 前景看好的新型大麻损伤检测工具(Druid应用程序)可能对公共安全具有无价价值 因为目前识别大麻损害的方法(例如，血液THC本身的限制)在很大程度上 效果不佳。最后，这些发现将有助于指导有关商业补贴的监管决策。 同时销售酒精和大麻以及同时含有酒精和THC的产品的机构。