Effect of Cannabidiol and Δ9-Tetrahydrocannabinol on Driving Performance A Randomized Clinical Trial
Effect of Cannabidiol and Δ9-Tetrahydrocannabinol on Driving Performance A Randomized Clinical Trial
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DOI：
10.1001/jama.2020.21218
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发表时间：
2020-12-01
影响因子：
120.7
通讯作者：
Ramaekers, Johannes G.
中科院分区：
文献类型：
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作者：
Arkell, Thomas R.;Vinckenbosch, Frederick;Ramaekers, Johannes G.
大麻的使用与车祸风险增加有关，但大麻二酚（CBD）对驾驶的影响尚不清楚。目的探讨含δ（9）-四氢大麻酚（THC）和CBD的汽化大麻对驾驶功能的影响。设计、设置和参与者一项双盲、参与者内、随机临床试验于2019年5月20日至2020年3月27日在荷兰马斯特里赫特大学心理学和神经科学学院进行。参与者（N = 26）是偶尔使用大麻的健康人。干预参与者汽化THC占主导地位，CBD占主导地位，THC/CBD等同物和安慰剂大麻。THC和CBD剂量为13.75 mg。条件顺序是随机和平衡的。主要的结果和措施的主要终点是横向位置的标准偏差（SDLP;车道交织的措施）在100公里，道路上的驾驶测试，开始在40分钟和240分钟后大麻消费。在校准的血液酒精浓度（BAC）为0.02%时，SDLP相对于安慰剂增加了1.12 cm，在校准的BAC为0.05%时，SDLP相对于安慰剂增加了2.4 cm。结果在26名随机参与者中（平均[SD]年龄，23.2 [2.6]岁; 16名女性），22名（85%）完成了所有8项驾驶测试。在消费后40至100分钟，CBD占主导地位的大麻的SDLP为18.21 cm，THC占主导地位的大麻为20.59 cm，THC/CBD等同大麻为21.09 cm，安慰剂大麻为18.28 cm。SDLP显着增加THC占主导地位的大麻（+2.33 cm [95% CI，0.80至3.86]; P <.001）和THC/CBD等效大麻（+2.83 cm [95%CI，1.28至4.39]; P <.001），但CBD占主导地位的大麻（-0.05 cm [95%CI，-1.49至1.39]; P>.99），相对于安慰剂。在消费后240至300分钟，CBD占主导地位的大麻的SDLP为19.03 cm，THC占主导地位的大麻为19.88 cm，THC/CBD等同大麻为20.59 cm，安慰剂大麻为19.37 cm。相对于安慰剂，CBD（-0.34 cm [95% CI，-1.77至1.10]; P> 0.99）、THC（0.51 cm [95% CI，-1.01至2.02]; P> 0.99）或THC/CBD（1.22 cm [95% CI，-0.29至2.72]; P = 0.20）条件下的SDLP无显著差异。在188次试驾中，有16次（8.5%）因安全问题而终止。结论和相关性在一项评估道路驾驶测试期间驾驶性能的交叉临床试验中，与安慰剂相比，汽化THC占主导地位和THC/CBD等效大麻的SDLP在汽化后40至100分钟显着更大，但在汽化后240至300分钟内没有显着差异; CBD占主导地位的大麻和安慰剂之间没有显着差异。然而，CBD占主导地位的大麻的效应量可能没有排除临床上重要的损害，测试的剂量可能不代表常见的usage.Question什么是驾驶损伤的幅度和持续时间后，含有不同浓度的Delta（9）-tetraocannabinol（THC）和cannabidiol（CBD）的大麻汽化？在这项交叉临床试验中，26名健康参与者接受了道路驾驶测试，在汽化消耗后40至100分钟时，以CBD为主的大麻为18.21 cm，以THC为主的大麻为20.59 cm，THC/CBD等效大麻为21.09 cm，安慰剂组为18.26 cm。在240至300分钟时，CBD占主导地位的大麻的SDLP为19.03 cm，THC占主导地位的大麻为20.59 cm，THC/CBD等同大麻为19.88 cm，安慰剂为19.37 cm。与安慰剂相比，THC占主导地位和THC/CBD相当大麻的SDLP在消费后40至100分钟显着更大，但在240至300分钟内没有显着差异; CBD占主导地位的大麻和安慰剂之间没有显着差异。虽然这项研究没有发现CBD占主导地位的大麻和安慰剂之间在实验性道路驾驶测试中驾驶性能的统计学显著差异，但效果大小可能没有排除临床重要的损伤，这项交叉随机临床试验评估了健康的年轻成年志愿者在汽化消费大麻后的驾驶测试表现（Delta，9）-四氢大麻酚[THC]和大麻二酚[CBD]）与安慰剂。
Importance Cannabis use has been associated with increased crash risk, but the effect of cannabidiol (CBD) on driving is unclear. Objective To determine the driving impairment caused by vaporized cannabis containing Delta(9)-tetrahydrocannabinol (THC) and CBD. Design, Setting, and Participants A double-blind, within-participants, randomized clinical trial was conducted at the Faculty of Psychology and Neuroscience at Maastricht University in the Netherlands between May 20, 2019, and March 27, 2020. Participants (N = 26) were healthy occasional users of cannabis. Interventions Participants vaporized THC-dominant, CBD-dominant, THC/CBD-equivalent, and placebo cannabis. THC and CBD doses were 13.75 mg. Order of conditions was randomized and balanced. Main Outcomes and Measures The primary end point was standard deviation of lateral position (SDLP; a measure of lane weaving) during 100 km, on-road driving tests that commenced at 40 minutes and 240 minutes after cannabis consumption. At a calibrated blood alcohol concentration (BAC) of 0.02%, SDLP was increased relative to placebo by 1.12 cm, and at a calibrated BAC of 0.05%, SDLP was increased relative to placebo by 2.4 cm. Results Among 26 randomized participants (mean [SD] age, 23.2 [2.6] years; 16 women), 22 (85%) completed all 8 driving tests. At 40 to 100 minutes following consumption, the SDLP was 18.21 cm with CBD-dominant cannabis, 20.59 cm with THC-dominant cannabis, 21.09 cm with THC/CBD-equivalent cannabis, and 18.28 cm with placebo cannabis. SDLP was significantly increased by THC-dominant cannabis (+2.33 cm [95% CI, 0.80 to 3.86]; P < .001) and THC/CBD-equivalent cannabis (+2.83 cm [95% CI, 1.28 to 4.39]; P < .001) but not CBD-dominant cannabis (-0.05 cm [95% CI, -1.49 to 1.39]; P > .99), relative to placebo. At 240 to 300 minutes following consumption, the SDLP was 19.03 cm with CBD-dominant cannabis, 19.88 cm with THC-dominant cannabis, 20.59 cm with THC/CBD-equivalent cannabis, and 19.37 cm with placebo cannabis. The SDLP did not differ significantly in the CBD (-0.34 cm [95% CI, -1.77 to 1.10]; P > .99), THC (0.51 cm [95% CI, -1.01 to 2.02]; P > .99) or THC/CBD (1.22 cm [95% CI, -0.29 to 2.72]; P = .20) conditions, relative to placebo. Out of 188 test drives, 16 (8.5%) were terminated due to safety concerns. Conclusions and Relevance In a crossover clinical trial that assessed driving performance during on-road driving tests, the SDLP following vaporized THC-dominant and THC/CBD-equivalent cannabis compared with placebo was significantly greater at 40 to 100 minutes but not 240 to 300 minutes after vaporization; there were no significant differences between CBD-dominant cannabis and placebo. However, the effect size for CBD-dominant cannabis may not have excluded clinically important impairment, and the doses tested may not represent common usage.Question What is the magnitude and duration of driving impairment following vaporization of cannabis containing varying concentrations of Delta(9)-tetrahydrocannabinol (THC) and cannabidiol (CBD)? Findings In this crossover clinical trial that included 26 healthy participants who underwent on-road driving tests, the standard deviation of lateral position (SDLP, a measure of lane weaving, swerving, and overcorrecting) at 40 to 100 minutes following vaporized consumption was 18.21 cm for CBD-dominant cannabis, 20.59 cm for THC-dominant cannabis, 21.09 cm for THC/CBD-equivalent cannabis, and was 18.26 cm for placebo. At 240 to 300 minutes, the SDLP was 19.03 cm for CBD-dominant cannabis, 20.59 cm for THC-dominant cannabis, 19.88 cm for THC/CBD-equivalent cannabis, and 19.37 cm for placebo. Compared with placebo, SDLP with THC-dominant and THC/CBD-equivalent cannabis was significantly greater at 40 to 100 minutes but not 240 to 300 minutes after consumption; there were no significant differences between CBD-dominant cannabis and placebo. Meaning Although this study did not find statistically significant differences in driving performance during experimental on-road driving tests between CBD-dominant cannabis and placebo, the effect size may not have excluded clinically important impairment, and the doses tested may not necessarily represent common usage.This crossover randomized clinical trial evaluated driving test performance of healthy young adult volunteers after vaporized consumption of cannabis (Delta(9)-tetrahydrocannabinol [THC] and cannabidiol [CBD]) vs placebo.