Pharmacological and physiological effects of cannabidiol: a dose escalation, placebo washout study protocol

TL;DR

This study explores how different doses of cannabidiol (CBD) affect healthy athletes' physiology and psychology, aiming to find an optimal dose for potential injury prevention and recovery.

Contribution

The study introduces a dose-escalation protocol for CBD in contact-sport athletes to determine an optimal dose based on pharmacokinetic, physiological, and psychological data.

Findings

CBD dosages will be escalated from 5 to 30 mg/kg/day in 5 mg/kg/day increments over two weeks.

Physiological and psychological assessments will be correlated with pharmacokinetic data to identify CBD's effects.

The study aims to establish a dosing regimen that could improve physiological function and reduce mild traumatic injuries in athletes.

Abstract

Cannabinoids such as cannabidiol (CBD) exhibit anti-inflammatory properties and have the potential to act as a therapeutic following mild traumatic brain injury. There is limited evidence available on the pharmacological, physiological and psychological effects of escalating CBD dosages in a healthy, male, university athlete population. Furthermore, no dosing regimen for CBD is available with implications of improving physiological function. This study will develop an optimal CBD dose based on the pharmacokinetic data in contact-sport athletes. The physiological and psychological data will be correlated to the pharmacokinetic data to understand the mechanism(s) associated with an escalating CBD dose.

Forty participants will receive escalating doses of CBD ranging from 5 mg CBD/kg/day to 30 mg CBD/kg/day. The CBD dose is escalated every two weeks in increments of 5 mg CBD/kg/day. Participants will provide blood for pharmacological assessments at each of the 10 visits. Participants will complete a physiological assessment at each of the visits, including assessments of cerebral hemodynamics, blood pressure, electrocardiogram, seismocardiogram, transcranial magnetic stimulation, and salivary analysis for genomic sequencing. Finally, participants will complete a psychological assessment consisting of sleep, anxiety, and pain-related questionnaires.

This study will develop of an optimal CBD dose based on pharmacological, physiological, and psychological properties for future use during contact sport seasons to understand if CBD can help to reduce the frequency of mild traumatic injuries and enhance recovery.

Clinicaltrials.gov: NCT06204003.

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