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.
JAMA. 2020 Dec 1;324(21):2177-2186. doi: 10.1001/jama.2020.21218.
Cannabis use has been associated with increased crash risk, but the effect of cannabidiol (CBD) on driving is unclear.
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.
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.
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.
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.
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.
EU Clinical Trials Register: 2018-003945-40.
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。
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。
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。
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。
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。
欧盟临床试验注册:2018-003945-40。