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RECRUITING
NCT06204003
PHASE1

Cannabinoids for Pain Management and Neuroprotection From Concussion

Sponsor: University of Regina

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2024-02-15

Completion Date

2026-12

Last Updated

2024-07-01

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Cannabis/Hemp Isolate Extract

Formulation: CBD (99%; 0.1% THC isolate)

Locations (2)

University of Regina

Regina, Saskatchewan, Canada

Pasqua Hospital

Regina, Saskatchewan, Canada