Cannabinoids for Pain Management and Neuroprotection From Concussion

Launched by UNIVERSITY OF REGINA · Jan 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a cannabis-based product, specifically a hemp extract high in CBD (cannabidiol), for healthy young men who compete in contact sports. The researchers want to find out if taking this hemp extract daily is safe and does not cause any harmful effects on the body or mind. Participants will first take a placebo (a non-active substance) for two weeks, and then they will gradually receive increasing doses of CBD over a period of time. Throughout the study, participants will provide blood and saliva samples, complete health questionnaires, and undergo tests to monitor their heart and brain function.

To be eligible for this trial, participants must be healthy males aged 18 to 35 who participate in contact sports, do not regularly use cannabis or tobacco, and have no serious medical conditions. It's important that participants commit to attending all scheduled assessments and refrain from using any other cannabis or tobacco products during the study. This study is currently looking for volunteers, and it offers a unique opportunity to help researchers learn more about the potential benefits and safety of CBD for athletes.

Gender

MALE

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