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一个多中心的耐受性研究,用于治疗青少年慢性头痛的加拿大大麻丰富的大麻草本提取物:CAN-CHA协议

Manik Chhabra¹, Evan C Lewis², Robert Balshaw³

¹Department of Pharmacology & Therapeutics, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.

|September 20, 2024

概括

这项研究调查了加拿大大麻 (CBD) 丰富的大麻草本提取物 (CHE) 对患有慢性头痛的青少年的安全性和剂量. 这些发现将指导未来关于儿童疼痛管理的基于大麻的治疗方法的研究.

科学领域:

儿科神经学儿科神经学
大麻素治疗药物大麻素治疗药物
临床药理学临床药理学

背景情况:

加拿大儿科医生越来越多地使用大麻产品来治疗慢性头痛,尽管证据有限.
没有任何经过充分控制的研究来指导大麻的剂量,安全性或治疗儿童慢性疼痛的有效性.
青少年慢性头痛代表着一个重要的未满足的医疗需求.

研究的目的:

确定大麻植物提取物 (CHE) 富含大麻 (CBD) 的剂量和安全性,用于患有慢性头痛的青少年.
评估CBD丰富的CHE剂量升级的耐受性.
为未来儿童慢性头痛管理的随机对照试验的设计提供信息.

主要方法:

一项开放的,剂量升级耐受性研究,涉及20名患有慢性偏头痛的青少年 (14-17岁).
参与者接受了CBD丰富的CHE (THC:CBD 1:25) 的剂量从0.2-0.4毫克/公斤/天升至0.8-1.0毫克/公斤/天.
与青年,家长和专家指导委员会共同设计的协议.

主要成果:

研究方案是与青年,家长和专家共同设计的.
它描述了一项针对慢性头痛未对常规疗法反应的青少年的耐受性临床试验.
这是针对患有慢性头痛的青少年使用大麻产品的首次临床试验.

结论:

这项研究方案是第一个针对慢性头痛青少年的研究方案.
它将提供关于CBD丰富CHE的安全性和耐受性的关键数据.
结果将为未来对这一群体进行比较有效性临床试验的发展提供信息.

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