大麻二酚和 Δ9-四氢大麻酚对驾驶性能的影响:一项随机临床试验。

Effect of Cannabidiol and Δ9-Tetrahydrocannabinol on Driving Performance: A Randomized Clinical Trial.

机构信息

Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, Sydney, New South Wales, Australia.

Brain and Mind Centre, The University of Sydney, Sydney, New South Wales, Australia.

出版信息

JAMA. 2020 Dec 1;324(21):2177-2186. doi: 10.1001/jama.2020.21218.

Abstract

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 Δ9-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.

TRIAL REGISTRATION

EU Clinical Trials Register: 2018-003945-40.

摘要

重要性

大麻的使用与撞车风险的增加有关,但 CBD 对驾驶的影响尚不清楚。

目的

确定蒸发含有 Δ9-四氢大麻酚(THC)和 CBD 的大麻对驾驶的影响。

设计、设置和参与者:这是一项在荷兰马斯特里赫特大学心理与神经科学学院进行的双盲、参与者内、随机临床试验,于 2019 年 5 月 20 日至 2020 年 3 月 27 日进行。参与者(N=26)为偶尔使用大麻的健康人群。

干预措施

参与者蒸发了 THC 占主导地位、CBD 占主导地位、THC/CBD 等效和安慰剂大麻。THC 和 CBD 的剂量为 13.75 毫克。条件的顺序是随机和平衡的。

主要结果和测量

主要终点是在摄入大麻后 40 分钟和 240 分钟开始的 100 公里道路驾驶测试中的侧向位置标准差(SDLP;车道编织的衡量标准)。在校准的血液酒精浓度(BAC)为 0.02%时,与安慰剂相比,SDLP 增加了 1.12 厘米,在校准的 BAC 为 0.05%时,SDLP 增加了 2.4 厘米。

结果

在 26 名随机参与者中(平均[标准差]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。在摄入后 40 至 100 分钟,CBD 主导大麻的 SDLP 为 18.21 厘米,THC 主导大麻的 SDLP 为 20.59 厘米,THC/CBD 等效大麻的 SDLP 为 21.09 厘米,安慰剂大麻的 SDLP 为 18.28 厘米。与安慰剂相比,THC 主导大麻(+2.33 厘米[95%CI,0.80 至 3.86];P<0.001)和 THC/CBD 等效大麻(+2.83 厘米[95%CI,1.28 至 4.39];P<0.001)的 SDLP 显著增加,但 CBD 主导大麻(-0.05 厘米[95%CI,-1.49 至 1.39];P>0.99)的 SDLP 没有显著增加。在摄入后 240 至 300 分钟,CBD 主导大麻的 SDLP 为 19.03 厘米,THC 主导大麻的 SDLP 为 19.88 厘米,THC/CBD 等效大麻的 SDLP 为 20.59 厘米,安慰剂大麻的 SDLP 为 19.37 厘米。与安慰剂相比,CBD (-0.34 厘米[95%CI,-1.77 至 1.10];P>0.99)、THC(0.51 厘米[95%CI,-1.01 至 2.02];P>0.99)或 THC/CBD(1.22 厘米[95%CI,-0.29 至 2.72];P=0.20)条件下的 SDLP 差异均不显著。在 188 次测试驾驶中,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中驾驶表现的交叉临床试验中,与安慰剂相比,THC 主导和 THC/CBD 等效大麻在蒸发后 40 至 100 分钟时的 SDLP 显著增加,但在蒸发后 240 至 300 分钟时没有显著增加;CBD 主导大麻与安慰剂之间没有显著差异。然而,CBD 主导大麻的效应大小可能并未排除临床上重要的损伤,而且测试的剂量可能无法代表常见的使用。

试验注册

欧盟临床试验注册:2018-003945-40。

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