Faculty of Kinesiology & Health Studies, University of Regina, 3737 Wascana Pkwy, Regina, SK, S4S 0A2, Canada.
Cannabinoid Research Initiative of Saskatchewan (CRIS), Saskatoon, SK, Canada.
BMC Neurol. 2024 Sep 12;24(1):340. doi: 10.1186/s12883-024-03847-1.
Cannabinoids such as cannabidiol (CBD) exhibit anti-inflammatory properties and have the potential to act as a therapeutic following mild traumatic brain injury. There is limited evidence available on the pharmacological, physiological and psychological effects of escalating CBD dosages in a healthy, male, university athlete population. Furthermore, no dosing regimen for CBD is available with implications of improving physiological function. This study will develop an optimal CBD dose based on the pharmacokinetic data in contact-sport athletes. The physiological and psychological data will be correlated to the pharmacokinetic data to understand the mechanism(s) associated with an escalating CBD dose.
METHODS/DESIGN: Forty participants will receive escalating doses of CBD ranging from 5 mg CBD/kg/day to 30 mg CBD/kg/day. The CBD dose is escalated every two weeks in increments of 5 mg CBD/kg/day. Participants will provide blood for pharmacological assessments at each of the 10 visits. Participants will complete a physiological assessment at each of the visits, including assessments of cerebral hemodynamics, blood pressure, electrocardiogram, seismocardiogram, transcranial magnetic stimulation, and salivary analysis for genomic sequencing. Finally, participants will complete a psychological assessment consisting of sleep, anxiety, and pain-related questionnaires.
This study will develop of an optimal CBD dose based on pharmacological, physiological, and psychological properties for future use during contact sport seasons to understand if CBD can help to reduce the frequency of mild traumatic injuries and enhance recovery.
Clinicaltrials.gov: NCT06204003.
大麻素如大麻二酚（CBD）具有抗炎特性，并有潜力在轻度创伤性脑损伤后作为一种治疗方法。在健康男性大学生运动员群体中，关于递增 CBD 剂量的药理学、生理学和心理学效应的证据有限。此外，尚无改善生理功能的 CBD 剂量方案。本研究将根据接触性运动运动员的药代动力学数据确定最佳 CBD 剂量。将生理学和心理学数据与药代动力学数据相关联，以了解与递增 CBD 剂量相关的机制。
方法/设计：40 名参与者将接受递增剂量的 CBD，范围从 5mg CBD/kg/天到 30mg CBD/kg/天。每隔两周以 5mg CBD/kg/天的增量递增 CBD 剂量。参与者将在 10 次就诊中的每一次就诊时提供血液进行药理学评估。参与者将在每次就诊时完成生理评估，包括脑血流动力学、血压、心电图、地震心动图、经颅磁刺激和唾液分析进行基因组测序。最后，参与者将完成包括睡眠、焦虑和疼痛相关问卷的心理评估。
本研究将根据药理学、生理学和心理学特性确定最佳 CBD 剂量，以便在未来的接触性运动赛季中使用，以了解 CBD 是否有助于减少轻度创伤性损伤的频率并促进恢复。
Clinicaltrials.gov：NCT06204003。
