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Intravenous Alcohol and THC Effects on Simulated Driving and Related Cognition

静脉酒精和 THC 对模拟驾驶及相关认知的影响

基本信息

批准号：
9116745
负责人：
DEEPAK Cyril D'SOUZA
金额：
$ 15.54万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-08-01 至 2018-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9116745
关键词：
Acute Alcohol consumption Alcohols Applications Grants Attention Automobile Driving Awareness Cannabinoids Cannabis Cognition Computer Assisted Data Dose Double-Blind Method EP300 gene Electroencephalography Ethanol Evaluation Event Event-Related Potentials Foundations Health Health Policy Hour Impairment Infusion procedures Injury Intravenous Joints Laboratory Study Lateral Licensing Literature Measures Medical Methods Morbidity - disease rate Perception Performance Pharmaceutical Preparations Placebo Control Placebos Positioning Attribute Public Health Randomized Reporting Risk Saline Schedule Series Short-Term Memory Spices Stimulus System Testing Tetrahydrocannabinol United States alcohol content alcohol effect alcohol exposure breath alcohol measurement cognitive function cognitive testing drinking driving under influence early onset experience human subject impaired driving performance indexing marijuana use memory process mortality novel processing speed rapid detection synthetic cannabinoid vehicular accident visual motor young adult

项目摘要

DESCRIPTION (provided by applicant): Motor vehicle accidents (MVAs) are among the top 10 leading causes of morbidity and mortality worldwide (1). In 2012, within the United States (US) there were about 30,000 MVAs that resulted in 33,561 fatalities, in addition to 1,634,000 reported MVAs that caused injury (2). Alcohol and cannabis are very important contributors to both impaired driving and MVA's (3). While the effects of alcohol on driving are well- known and have been widely studied (4), the effects of cannabis or its constituent cannabinoids on driving are less clear (5), and there is even less known about the effects of the combination of alcohol and cannabinoids on driving. With the growing legalization of both recreational and "medical" use of cannabis, the growing perception, especially among young adults, that cannabis is safe (6), and the paucity of experimental data to inform public health policy regarding driving under the influence of both substances, there is a need to study the combined effects of cannabinoids and alcohol on driving. Hypothesis: The combination of modest recreational doses of THC and ethanol, will impair simulated driving, event related potentials (ERPs) relevant to driving, and driving related cognitive function to a greater extent than either drug individually. Methods: In a randomized, double-blind, placebo-controlled, crossover (2x2), counterbalanced laboratory study, healthy subjects (n=25) will simultaneously receive through separate intravenous (IV) lines 1) IV ethanol or placebo (saline) to reach a BrAC of 0.04% (equivalent to ~2 drinks over 1 hour) within 20 minutes and remain clamped at this level for an additional 60 minutes using a computer-assisted alcohol infusion system, and 2) IV THC (0.015 mg/kg = 1/4 - 1/2 cannabis joint) or placebo (saline) over 20 minutes. Subjects will complete 1) a day and night driving course on a driving simulator, while EEG is recorded to obtain the driving error related ERPs - ERN and Pe; 2) an EEG P300 novelty task, and 3) a battery (CogState) of cognitive tests relevant to driving. Supporting feasibility data: We have the experience and expertise, to administer IV ethanol (n>20) and THC (n>400), in addition to having the regulatory approvals (IND, Schedule 1 license) necessary to administer IV THC. We have demonstrated that IV ethanol increases SDLP on a simulated driving task, and have also shown the separate effects of both IV ethanol and IV THC on reducing amplitude of the P3a.

描述（由申请人提供）：机动车事故（MVA）是全球发病率和死亡率的十大主要原因之一（1）。2012年，在美国（US），大约有30，000起MVA导致33，561人死亡，此外还有1，634，000起报告的MVA造成伤害（2）。酒精和大麻是导致驾驶障碍和MVA的非常重要的因素（3）。虽然酒精对驾驶的影响是众所周知的，并已被广泛研究（4），大麻或其成分大麻素对驾驶的影响不太清楚（5），更不知道酒精和大麻素的组合对驾驶的影响。随着娱乐和“医疗”使用大麻的日益合法化，越来越多的人，特别是年轻人，认为大麻是安全的（6），以及缺乏实验数据来告知公共卫生政策，关于在这两种物质的影响下驾驶，有必要研究大麻素和酒精对驾驶的综合影响。假设：适度娱乐剂量的THC和乙醇的组合将损害模拟驾驶、与驾驶相关的事件相关电位（ERP）以及驾驶相关的认知功能，其程度大于单独使用任一种药物。方法：采用随机、双盲、安慰剂对照、交叉（2x2）、平衡实验室研究，健康受试者（n=25）将通过单独的静脉内（IV）管线同时接受1）IV乙醇或安慰剂（盐水）以达到0.04%的BrAC（相当于1小时内约2次饮酒），并使用计算机辅助酒精输注系统在此水平下保持钳夹另外60分钟，和2）IV THC（0.015mg/kg = 1/4 - 1/2大麻关节）或安慰剂（盐水）超过20分钟。受试者将完成1）驾驶模拟器上的昼夜驾驶课程，同时记录EEG以获得驾驶错误相关的ERPs - ERN和Pe; 2）EEG P300新奇任务，以及3）与驾驶相关的认知测试电池（CogState）。支持性可行性数据：我们拥有管理IV乙醇（n>20）和THC（n>400）的经验和专业知识，此外还拥有管理IV THC所需的监管批准（IND，附表1许可证）。我们已经证明，IV乙醇增加SDLP的模拟驾驶任务，也显示了单独的影响，IV乙醇和IV THC降低幅度的P3 a。