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.
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.
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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
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发表时间：
2022
影响因子：
5.6
通讯作者：
Spindle, Tory R.
中科院分区：
文献类型：
--
作者：
Zamarripa, C. Austin;Novak, Matthew D.;Weerts, Elise M.;Vandrey, Ryan;Spindle, Tory R.
药用和非药用大麻的合法化，以及大麻产品多样性的相应增加，导致迫切需要大麻监管科学。最迫切的需求之一是与大麻接触造成的损害有关的研究，特别是对驾驶性能的研究。本项目旨在评估口服和汽化大麻单独使用或与酒精混合使用对模拟驾驶表现（STISIM驾驶模拟器）、认知/精神运动能力和现场清醒表现的影响。健康成年人将完成两项双盲、双假、安慰剂对照、随机交叉临床实验室研究，其中一项使用口服大麻（16名男性/16名女性），另一项使用蒸发大麻（16名男性/16名女性）。在每项研究中，参与者将完成七个实验阶段，在此期间，受试者将单独或与安慰剂或含酒精饮料（目标呼气酒精浓度，BAC为0.0%或0.05%）联合服用急性剂量的安慰剂或含有0、10或25毫克Δ9-THC的高Δ9-THC大麻。另外还将进行阳性对照试验（即酒精浓度达到0.08%的目标，同时使用大麻安慰剂）。模拟驾驶性能测试（可下载，见方法）、现场清醒度评估、主观药物效应问卷、移动设备损伤测试（DRUID app）、全血样本采集将在每个阶段重复完成。将使用线性混合模型来测试实验条件之间的差异，并使用先验计划比较来确定感兴趣条件之间的差异（例如，单独的大麻与含酒精的大麻）。这项研究的目的是通过使用口服和汽化的大麻给药途径，扩展先前关于大麻和酒精对驾驶性能的研究。通过加深对与酒精和这些新型大麻共同使用有关的损害的了解，这项研究可以为大麻和酒精的损害检测标准提供信息，并对执法、有关这些物质可及性的公共政策决定以及可能使用大麻和/或酒精的一般人群的教育产生重要影响。最后，本文为感兴趣的研究人员提供了模拟驾驶场景和为本研究开发的数据提取工具，作为促进未来交叉研究比较的手段，这一点很重要，因为在之前的研究中，不同实验室使用的方法存在异质性。
The legalization of cannabis for medicinal and non-medicinal purposes, and the corresponding increase in diversity of cannabis products, has resulted an urgent need for cannabis regulatory science. Among the most pressing needs is research related to impairment due to cannabis exposure, especially on driving performance. The present project was designed to evaluate the impact of oral and vaporized cannabis, when administered alone or in combination with alcohol, on simulated driving performance (STISIM driving simulator), cognitive/psychomotor ability, and field sobriety performance. Healthy adults will complete two, double-blind, double-dummy, placebo-controlled, randomized crossover clinical laboratory studies, one with oral cannabis (16 men/16 women) and the second with vaporized cannabis (16 men/16 women). In each study, participants will complete seven experimental sessions during which acute doses of placebo or high Δ9-THC cannabis containing 0, 10, or 25 mg Δ9-THC will be administered both alone and in combination with placebo or alcohol-containing beverages (target breath alcohol concentrations, BAC, of 0.0% or 0.05%). A positive control session (i.e., alcohol at target BAC of 0.08% with placebo cannabis) will also be completed. Simulated driving performance tests (available for download; see Methods), field sobriety assessments, subjective drug effect questionnaires, a mobile device impairment test (DRUID app), and collection of whole blood specimens will be completed repeatedly during each session. Linear mixed models will be used to test for differences across experimental conditions and a priori planned comparisons will be used to determine differences between conditions of interest (e.g., cannabis alone vs cannabis with alcohol). This research is designed to extend prior studies of cannabis and alcohol on driving performance by using oral and vaporized routes of cannabis administration. By increasing understanding of impairment associated with co-use of alcohol and these novel forms of cannabis, this research could inform impairment detection standards for cannabis and alcohol and have important implications for law enforcement, public policy decisions regarding accessibility of these substances, and education of the general population who may use cannabis and/or alcohol. Lastly, this manuscript provides interested researchers with access to the simulated driving scenarios and data extraction tools developed for this study as a means of facilitating future cross-study comparisons, which is important given the heterogeneity in methods used across laboratories in prior research.
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影响因子：
3.4
作者：
Uhart M;Weerts EM;McCaul ME;Guo X;Yan X;Kranzler HR;Li N;Wand GS
通讯作者：
Wand GS
影响因子：
4.4
作者：
Hammond, David
通讯作者：
Hammond, David
影响因子：
2
作者：
KIDD, P;HUDDLESTON, S
通讯作者：
HUDDLESTON, S
影响因子：
6
作者：
Fink, David S.;Stohl, Malki;Hasin, Deborah S.
通讯作者：
Hasin, Deborah S.
影响因子：
120.7
作者：
Arkell, Thomas R.;Vinckenbosch, Frederick;Ramaekers, Johannes G.
通讯作者：
Ramaekers, Johannes G.