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Publications

Journal Article Clinical Trial Protocol Epublish

PubMed: 39979051 DOI: 10.1136/bmjopen-2024-092919

Impact of an acute 1-month cannabidiol treatment on pain and inflammation after a long bone fracture: a triple-blind randomised, placebo-controlled, clinical trial protocol.

BMJ Open 15(2):e092919

Authors: Daphnée Brazeau, Amelie A Deshaies, David Williamson, Francis Bernard, Caroline Arbour, Anne Marie Pinard, Dominique Rouleau, Louis De Beaumont

Affiliations

  • Psychology, University of Montreal, Montreal, Quebec, Canada.
  • CIUSSS du Nord-de-l'Ile-de-Montreal, Montreal, Quebec, Canada.
  • Pharmacie, University of Montreal, Montreal, Quebec, Canada.
  • Hopital du Sacre-Coeur de Montreal, Montreal, Quebec, Canada.
  • Medecine Faculty, University of Montreal, Montreal, Quebec, Canada.
  • Nursing, University of Montreal, Montreal, Quebec, Canada.
  • Université Laval, Montreal, Quebec, Canada.
  • CIUSSS du Nord-de-l'Ile-de-Montreal, Montreal, Quebec, Canada.
  • Department of Surgery, Université de Montréal, Montreal, Quebec, Canada.

Abstract

INTRODUCTION

Acute pain levels following orthopaedic injury (eg, fracture) are a predictor of the onset of chronic pain, which affects nearly 50% of fracture patients and impairs functional recovery. Among current pharmacological treatments for acute pain, non-steroidal anti-inflammatory drugs have been associated with delayed bone healing, while opioids inhibit effective bone remodelling, increase the risk of pseudarthrosis and carry a high risk of addiction. In light of this, the development of new pain treatments is essential. Cannabidiol (CBD), a non-addictive and non-psychotropic cannabis component stands out as a potential therapeutic agent, given its analgesic and anti-inflammatory properties as well as its potential benefits for bone healing. This randomised controlled trial aims to investigate the effect of acute CBD treatment, compared with placebo, on patients' self-reported pain, inflammation and well-being following a fracture injury.

METHODS AND ANALYSIS

This is a triple-blind, randomised, placebo-controlled clinical trial. A total of 225 adults aged 18-70 years, who have suffered a long bone fracture and were treated at the Hôpital du Sacré-Coeur de Montréal, will be randomly assigned within 1 week to one of three treatment arms (25 mg or 50 mg of CBD or placebo) for 1 month. The primary outcome will be the difference in the pain score between groups at 1-month follow-up. Secondary outcomes will include measures of persistent pain, inflammation, opioid usage, quality of life, sleep quality, depression, anxiety, cognition and orthopaedic function. Data will be collected at baseline, 1-month and 3-month follow-ups.

ETHICS AND DISSEMINATION

This study obtained a Health Canada licence for use of cannabis products. It has also been approved by Health Canada and the Research Ethics Board of the CIUSSS du Nord-de-l'Île-de-Montréal (Project ID 2025-2105). The findings will be published in a peer-reviewed journal and presented at local, national and international conferences. The trial's results will be made publicly available on the ClinicalTrials.gov database.

TRIAL REGISTRATION NUMBER

NCT06448923.

MeSH

Clinical Protocols, Pain, Fractures, Bone, Therapeutics, Cannabidiol