NCT06204003

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: University of Regina · Academic / Other
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

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 participants taking a placebo before starting the CBD regimen. This study is designed to investigate anti-inflammatory and neuroprotection of the CBD formulation to determine whether it can be used on a daily basis safely during the periods of intensive exercise (resistance) training during the off-season prior to competition. The primary research hypothesis is that cannabis/hemp-based products with high CBD are safe, well-tolerated and do not cause adverse physiological and psychological dysfunction when administered on a daily basis. Specifically, the investigators will investigate the pharmacokinetic, physiological, and psychological effects of CBD. The investigators hypothesize that the CBD formulations will be non-intoxicating (non-psychotropic), safe, well-tolerated and do not cause adverse physiological or psychological dysfunction. Secondary research hypotheses for this clinical trial: 1. Pharmacokinetic data will provide the investigators with the 'optimal' formulation for daily administration for neuroprotection from concussion 2. Plasma levels of CBD and/or its active metabolites will correlate with cerebrovascular, neurophysiology and cardiovascular physiology outcome variables. 3. Saliva levels of CBD and/or its active metabolites will correlate with plasma samples.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cannabis/Hemp Isolate Extract	Formulation: CBD (99%; 0.1% THC isolate)

Timeline

• Start date: 2024-02-15
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-01-12
• Last updated: 2024-07-01

Locations

2 sites across 1 country: Canada