Using cannabinoids for pain management and concussion protection in athletes

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

This study is testing if a cannabis extract can safely help young male athletes manage pain and protect against concussions while they train.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years to 35 Years
• Sex: Male
• Sponsor: University of Regina (Academic / other)
• Locations: 2 sites (Regina, Saskatchewan and 1 other locations)
• Trial ID: NCT06204003 on ClinicalTrials.gov

What this trial studies

This open-label, placebo-controlled Phase I trial aims to assess the safety and tolerability of a Cannabis/Hemp Isolate Extract in healthy male adults aged 18-35 who compete in contact sports. Participants will undergo a dosage escalation regimen starting with a low dose of CBD, which will be increased over time, while also providing blood and saliva samples for pharmacokinetic and genetic analysis. The study seeks to determine if high CBD formulations can be safely administered daily without adverse effects during intensive training periods. The primary hypothesis is that these products are non-intoxicating and well-tolerated.

Who should consider this trial

Good fit: Ideal candidates are healthy male adults aged 18-35 who actively participate in contact sports.

Not a fit: Patients who are female or have a history of cerebrovascular or cardiovascular complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safe method for pain management and neuroprotection in athletes, potentially reducing the risk of concussion-related injuries.

How similar studies have performed: While there is emerging interest in cannabinoids for various therapeutic uses, this specific approach in elite athletes is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

Inclusion Criteria:

* Healthy male adults between 18-35 years of age that compete in contact sport athletics
* No known cerebrovascular or cardiovascular complications
* Not habitual recreational users of cannabis (i.e., \<1 day/week) or tobacco users
* Agree not to consume any other cannabis or tobacco products while enrolled in the study
* Agree to list any prescription medications being taken
* Ability to maintain commitment to all proposed biopsychological and health questionnaires, and neuro-physiological, physiological, perceptual-cognitive, and functional motor skills laboratory tests

Exclusion Criteria:

* Female
* Requirement to 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 enrolment in the study)
* Any level of cannabis in blood samples when sampled at the commencement of the study
* Medically supervised for anxiety, depression, or other neurological conditions
* Initiation or dosage change of oral or injected steroids within past 3 months
* Allergy or known intolerance to any of the compounds within the study preparation
* Inability to attend assessments on a regular basis at the pre-determined times, or failure to take drug on a daily basis
* Clinically significant cardiac, renal or hepatic disease (as assessed by the site investigator)
* Concussion

Where this trial is running

Regina, Saskatchewan and 1 other locations

• University of Regina — Regina, Saskatchewan, Canada (Recruiting)
• Pasqua Hospital — Regina, Saskatchewan, Canada (Not_yet_recruiting)

Study contacts

• Principal investigator: Payam Dehghani, — Saskatchewan Health Authority - Regina Area
• Study coordinator: Patrick Neary

Conditions Healthy