Naturally Produced Cannabinoids for Neuroprotection From Concussion

Официальное название

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

Обзор

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.

Подробное описание

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:

1. The cannabinoid formulation will result in improved physiological and psychological performance throughout the competitive season compared to placebo. 2. 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:

1. The investigators will conduct the first ever randomized controlled trial to understand the neuroprotective effects of a cannabinoid formulation designed to mitigate concussion in a population at a heightened risk of concussion and understand if recovery with the cannabinoid formulation more rapidly improves concussion symptoms. 2. The investigators will use an integrated approach to examine the effects of our cannabinoid formulation on qualitative and quantitative outcome measures including clinical, physiological, neurophysiological, biopsychological, and functional motor performance. 3. The cannabinoid levels will be studied in the blood to assess the pharmacokinetics and pharmacodynamics of these compounds and correlate these with our cerebrovascular, cardiovascular and neurophysiological indices. 4. The investigators will genotype participant blood samples for known polymorphisms (single nucleotide polymorphisms, copy number variants, etc.) and relate our findings to observed drug effect in study participants. 5. The investigators will investigate the effects of the cannabinoid formulation on the gut microbiome from stool samples, which has been implicated to have an effect on concussion.

Вмешательства

• Препарат Broad spectrum cannabinoid formulation
  Broad spectrum cannabinoid formulation gel capsule
• Другое Placebo gel capsule
  Placebo gel capsule will have MCT oil only, no active ingredient

Первичные конечные точки

• Plasma cannabidiol (CBD) metabolite concentration [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]
• Plasma tetrahydrocannabinol (THC) metabolite concentration [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]
• Inflammatory biomarker concentrations in blood [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]
• Liver function laboratory values [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]
• Hematology and clinical chemistry laboratory values [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]
• Cerebral blood flow velocity [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]
• Cerebral oxygenation [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]
• Continuous blood pressure [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]
• Changes in cardiovascular physiology [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]
• Officially diagnosed concussion incidence [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]

Вторичные конечные точки (11)

• Cortical inhibition measured by transcranial magnetic stimulation (TMS) [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]
• Brief Pain Inventory-Short Form Pain Interference score [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]
• Brief Pain Inventory-Short Form Pain Severity Score [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]
• McGill Pain Questionnaire-Short Form pain score [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]
• Numeric Rating Scale for Pain score [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants.]
• Pain Behaviour Measurement score [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]
• Change in Leeds Sleep Evaluation Questionnaire (LSEQ) score [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]
• Vertical Jump Performance [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]
• Adverse Event Incidence [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]
• Stool microbiome composition [Срок оценки: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).]
• Identification of genetic markers associated with cannabinoid metabolism [Срок оценки: Baseline assessment.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Female.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• University of Regina — Regina

Идентификаторы

NCT: NCT07715864 · Bio3456 · NFL-NEUROPROTECTION-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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