Cannabinoids for Pain Management and Neuroprotection From Concussion
HealthyThe 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 competition.
The main question it aims to answer is:
• Are cannabis/hemp-based products with high CBD safe, well-tolerated and without adverse physiological and psychological dysfunction, when administered on a daily basis?
Participants will:
* be given CBD and a placebo. The placebo will be taken for 2 weeks prior to starting the CBD. Participants will start on a low dose of CBD, beginning at 5 mg CBD/kg body mass, which will be increased by 5 mg/kg every 2-weeks until 30 mg CBD/kg body mass is taken;
* have blood samples taken to analyse how much CBD is used in the body and for how long it lasts in the body (pharmacokinetics and pharmacodynamics);
* have saliva samples collected for genetic analysis;
* undergo testing sessions, which will include psychological and health questionnaires, equipment to record signals from the brain and heart, and safety laboratory tests.
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Participation Requirements
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Sex:
MALE -
Eligible Ages:
18 to 35
Participation 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
Study Location
Pasqua Hospital
Pasqua HospitalRegina, Saskatchewan
Canada
Contact Study Team
University of Regina
University of ReginaRegina, Saskatchewan
Canada
Contact Study Team
Patrick Neary
- Study Sponsored By
- University of Regina
- Participants Required
- More Information
- Study ID:
NCT06204003