Carlini E A, Cunha J M
J Clin Pharmacol. 1981 Aug-Sep;21(S1):417S-427S. doi: 10.1002/j.1552-4604.1981.tb02622.x.
Clinical trials with cannabidiol (CBD) in healthy volunteers, isomniacs, and epileptic patients conducted in the authors' laboratory from 1972 up to the present are reviewed. Acute doses of cannabidiol ranging from 10 to 600 mg and chronic administration of 10 mg for 20 days or 3 mg/kg/day for 30 days did not induce psychologic or physical symptoms suggestive of psychotropic or toxic effects; however, several volunteers complained of somnolence. Complementary laboratory tests (EKG, blood pressure, and blood and urine analysis) revealed no sign of toxicity. Doses of 40, 80, and 160 mg cannabidiol were compared to placebo and 5 mg nitrazepam in 15 insomniac volunteers. Subjects receiving 160 mg cannabidiol reported having slept significantly more than those receiving placebo; the volunteers also reported significantly less dream recall; with the three doses of cannabidiol than with placebo. Fifteen patients suffering from secondary generalized epilepsy refractory to known antiepileptic drugs received either 200 to 300 mg cannabidiol daily or placebo for as long as 4.5 months. Seven out of the eight epileptics receiving cannabidiol had improvement of their disease state, whereas only one placebo patient improved.
本文回顾了自1972年至今在作者实验室对健康志愿者、失眠者和癫痫患者进行的大麻二酚(CBD)临床试验。急性剂量的大麻二酚范围为10至600毫克,以及连续20天给予10毫克或连续30天给予3毫克/千克/天的慢性给药,均未诱发提示精神药物或毒性作用的心理或身体症状;然而,有几名志愿者抱怨嗜睡。补充实验室检查(心电图、血压以及血液和尿液分析)未显示毒性迹象。在15名失眠志愿者中,将40、80和160毫克大麻二酚的剂量与安慰剂和5毫克硝西泮进行了比较。接受160毫克大麻二酚的受试者报告的睡眠时间明显多于接受安慰剂的受试者;与安慰剂相比,接受三种剂量大麻二酚的志愿者还报告说梦境回忆明显减少。15名对已知抗癫痫药物难治的继发性全身性癫痫患者接受了长达4.5个月的每日200至300毫克大麻二酚或安慰剂治疗。接受大麻二酚治疗的8名癫痫患者中有7名病情有所改善,而接受安慰剂治疗的患者中只有1名有所改善。