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: 10620860
• 负责人: Tory Richard Spindle
• 金额: $ 63.45万
• 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/10620860
• 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; Placebo Control; 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; cannabis administration; 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

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.

项目总结/摘要 大麻和酒精是世界上最常用的两种毒品，经常同时使用 (i.e.,“共同使用”）。当单独使用时，大麻和酒精都会损害心理技能，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， 职场先前的实验室研究表明，大麻/酒精的共同使用可以产生叠加效应， 流行病学研究表明， 当一个人同时使用大麻和酒精时，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 虽然大麻的主要形式是烟熏形式，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（“食用品”）和大麻的急性影响 汽化器（两种流行的新型大麻）与吸食大麻有明显不同。这些发现 表明口服和汽化大麻可能以不同于吸食大麻的方式与酒精相互作用。 该项目的目的是系统地评估大麻和酒精的急性损害作用， 在两项人体实验室研究中，单独和一起给药，这些研究将利用严格的双盲，双盲， 虚拟的安慰剂对照设计。这些研究将因大麻给药途径而异（研究1：口服; 研究2：蒸发），但在其他方面将使用基本相同的方案。在每项研究中，参与者将 完成7次门诊药物给药，其中他们自行服用安慰剂或活性大麻 (10或25毫克四氢大麻酚）和安慰剂饮料或酒精饮料计算产生呼吸酒精浓度 (BAC)0.05%。参与者还将完成一个阳性对照阶段，在该阶段他们将服用安慰剂 大麻和酒精的目标BAC为0.08%（法律的阈值，或“本身的限制，”为驾驶障碍， 美国大部分州）。课程将以随机顺序完成，并至少间隔一周。 评估将包括最先进的驾驶模拟器，认知/心理表现电池 任务，现场清醒测试，和主观药物效果问卷。这项研究可以告知损伤 同时使用大麻和酒精的个人的检测标准（例如，确定0.08% BAC是否为 适当的酒精中毒阈值，如果一个人也使用大麻），这可以告知是否有一个 需要调整大麻法律的地区的BAC本身限制。此外，这项研究将评估一个 有前途的新型大麻损伤检测工具（DRUID应用程序），这对公共安全可能是非常宝贵的 因为目前识别大麻损害的方法（例如，血液THC本身的限制）主要是 无效。最后，这些研究结果将有助于指导有关允许商业 销售酒精和大麻以及含有酒精和THC的产品的机构。

项目成果

The effects of oral and vaporized cannabis alone, and in combination with alcohol, on driving performance using the STISIM driving simulator: A two-part, double-blind, double-dummy, placebo-controlled, randomized crossover clinical laboratory protocol.

仅口服和蒸发大麻，以及与酒精结合使用Stisim驾驶模拟器的驾驶性能的影响：两部分，双盲，双重夜间，安慰剂对照，随机的，随机的交叉临床实验室方案。

• DOI: 10.3389/fphar.2022.964749
• 发表时间: 2022
• 期刊: FRONTIERS IN PHARMACOLOGY
• 影响因子: 5.6
• 作者: Zamarripa, C. Austin;Novak, Matthew D.;Weerts, Elise M.;Vandrey, Ryan;Spindle, Tory R.
• 通讯作者: Spindle, Tory R.