RecruitingPhase 1NCT06204003

Cannabinoids for Pain Management and Neuroprotection From Concussion

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

Sponsor

University of Regina

Enrollment

35 participants

Start Date

Feb 15, 2024

Study Type

INTERVENTIONAL

Conditions

Healthy

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 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.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 35 Years

Inclusion Criteria6

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 Criteria10

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