Naturally Produced Cannabinoids for Pain Management and Neuroprotection From Concussion During Participation in Contact Sports: Neuroprotection

University of Regina1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2026年6月1日最近更新: 2026年7月21日

适应症

试验速览

阶段: 2 期
状态: 招募中
发起方: University of Regina
入组人数: 60
试验地点: 1
主要终点: Plasma cannabidiol (CBD) metabolite concentration

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this double-blind, placebo-controlled, cross over study is to learn about the neuroprotective properties of a broad-spectrum cannabinoid formulation in normal healthy adults engaged in elite contact sport competition.

The main question it aims to answer :

• Is the broad-spectrum cannabinoid formulation neuroprotective for athletes participating in competitive contact sports? Can this formulation facilitate recovery in those who suffer from concussion by reducing inflammation and/or reduce the number of concussions sustained without adverse physiological and psychological dysfunction when administered daily?

Participants will:

be given a broad-spectrum cannabinoid gel capsule or a placebo twice daily.
have blood samples taken to analyze pharmacokinetics and pharmacodynamics of cannabinoid metabolites, liver function, complete blood count and blood differential, inflammatory biomarkers and genetic analysis
have stool samples collected for gut microbiome analysis;
undergo testing sessions, which will include psychological and health questionnaires, equipment to record signals from the brain and heart, and safety laboratory tests.

详细描述

This research project will be a Phase II clinical trial to test the neuroprotective properties of the broad spectrum cannabinoid formulation. Specifically, the investigators will assess the neuroprotective properties of the cannabinoid formulation during a competitive season of contact football or ice hockey in elite university varsity athletics.

The primary research hypothesis is that the cannabinoid formulation will be neuroprotective for athletes in a competitive university varsity football or hockey season and will help to reduce the number of concussions sustained by the athletes in comparison to previous seasons, and in comparison, to the Placebo group. Furthermore, it is expected that the cannabinoid formulation will facilitate recovery in those who do suffer from a concussion by reducing inflammation.

The secondary hypotheses are:

The cannabinoid formulation will result in improved physiological and psychological performance throughout the competitive season compared to placebo.
The inflammatory markers will be reduced in those taking the cannabinoid formulation as compared to those taking placebo.

This research study is unique and important for several reasons:

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 19 Years 至 35 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy male adults between 19-35 years of age that compete in contact sport athletics.
•Participants with no known cerebrovascular or cardiovascular complications.
•Participants will not be habitual recreational users of cannabis (i.e., <1 day/week) or tobacco users.
•Participants that agree not use any other cannabis or tobacco products while enrolled in the study.
•Participants willing to provide a list of any prescription medications they are taking.
•Ability to maintain commitment to all proposed biopsychological and health questionnaires, and neuro-physiological, physiological, perceptual-cognitive, and functional motor skills laboratory tests.
•Participants who are capable of giving signed informed consent.

排除标准

•Must not travel to the USA during study period; USA laws do not permit cross border with cannabis products.
•Use of cannabis-based therapy within 2 months (participants who have previously used a cannabis based therapy may be included if they have a 2-month period without use of cannabis-based therapy prior to enrollment in the study).
•Participants with any level of cannabis in their blood samples when sampled at the commencement of the study will be excluded.
•Participants that are being medically supervised for anxiety, depression, Post Traumatic Stress Disorder (PTSD), mood disorder, psychotic disorders or any cerebrovascular and cardiovascular complications.
•Participants who are taking prescription medications such as psychotropic medications with serotonergic activity, including Selective Serotonin Reuptake Inhibitors (i.e. Fluoxetine), Tricyclic Antidepressants (i.e. Elavil, Nortriptyline) and Atypical Neuroleptics (i.e. Risperidone, Seroquel).
•Initiation or dosage change of oral or injected steroids within 3 months.
•Allergy or known intolerance to any of the compounds within the study preparation.
•Unable to maintain commitment to all proposed biopsychological and health questionnaires, and neuro-physiological, physiological, and functional motor skills laboratory tests.
•Inability of study participants to attend assessments on a regular basis at the pre-determined times, or failure to take the drug daily.
•Clinically significant cardiac, renal or hepatic disease (as assessed by the site investigator).
•If they already have a concussion at the time of starting the study.