NCT07715864 Naturally Produced Cannabinoids for Neuroprotection From Concussion
| NCT ID | NCT07715864 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Regina |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2026-06-01 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07715864 clinical trial?
This trial is open to male participants only, aged 19 Years or older, up to 35 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07715864 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07715864 currently recruiting?
Yes, NCT07715864 is actively recruiting participants. Contact the research team at Patrick.Neary@uregina.ca for enrollment information.
Where is the NCT07715864 trial being conducted?
This trial is being conducted at Regina, Canada.
Who is sponsoring the NCT07715864 clinical trial?
NCT07715864 is sponsored by University of Regina. The trial plans to enroll 60 participants.