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（由适用提供）：汽车事故（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（美国），大约有30,000名MVA导致33,561人死亡，此外还有1,634,000名造成伤害的MVA（2）。酒精和大麻是驾驶受损和MVA的非常重要的贡献者（3）。虽然酒精对驾驶的影响是众所周知的，并且已经广泛研究（4），但大麻或其构成大麻素对驾驶的影响尚不清楚（5），并且对酒精和大麻素对驾驶的影响的影响甚至鲜为人知。随着大麻娱乐和“医学”使用的合法化，尤其是在年轻人中，大麻是安全的（6），以及实验数据的匮乏，以告知公共卫生政策，以告知公共卫生政策在两种物质的影响下，都需要研究大麻素素和酒精对驾驶的综合作用。假设：THC和乙醇的适度休闲剂量的组合将损害模拟驾驶，与驾驶相关的事件相关电位（ERP）以及相关的认知功能，而不是单独的任何一种药物。方法：随机，双盲，安慰剂对照，跨界（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）第1条）IV乙醇或安慰剂（盐水）接收，以在20分钟内使用20分钟的时间，并在20分钟内使用廉价的60分钟，以达到0.04％的BRAC，以达到0.04％的BRAC（相当于〜2饮料） 2）IV THC（0.015 mg/kg = 1/4-1/2大麻关节）或安慰剂（盐水）在20分钟内。受试者将在驾驶模拟器上完成1）昼夜驾驶课程，而记录EEG以获取与驾驶错误相关的ERP -ERN和PE； 2）EEG P300新颖任务，以及3）与驾驶相关的认知测试的电池（Cogstate）。支持可行性数据：我们具有管理IV乙醇（n> 20）和THC（n> 400）的经验和专业知识，此外还具有监管部门批准（IND，附表1许可证）来管理IV THC。我们已经证明，IV乙醇在模拟驾驶任务上增加了SDLP，并且还显示了IV乙醇和IV THC对减少P3A放大器的单独影响。