Status:
RECRUITING
Cannabinoids for Pain Management and Neuroprotection From Concussion
Lead Sponsor:
University of Regina
Collaborating Sponsors:
National Football League (NFL)
My Next Health Inc.
Conditions:
Healthy
Eligibility:
MALE
18-35 years
Phase:
PHASE1
Brief Summary
The goal of this open-label, placebo-controlled, dosage escalation study is to learn about the safety of a Cannabis/Hemp Isolate Extract in normal healthy adults engaged in elite contact sport competi...
Detailed Description
This research project will be a Phase I clinical trial to test the safety, efficacy and tolerability of the drug formulation. Specifically, the investigators will use a dose escalation study with all ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06204003
Start Date
February 15 2024
End Date
December 1 2026
Last Update
July 1 2024
Active Locations (2)
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1
University of Regina
Regina, Saskatchewan, Canada, S4S 0A2
2
Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1