Cannabidiol for pain relief after traumatic fractures and to reduce opioid use

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled Phase 2 trial compares two daily doses of cannabidiol (low and moderate) to placebo given for one month to adults with recent long-bone fractures. Pain outcomes will be followed over time and the study will also measure inflammatory markers, opioid consumption, quality of life, sleep, mood, cognition, and orthopedic function. The protocol examines sex differences and potential interactions between CBD and opioid analgesics, and includes biomarker analyses to link clinical effects to inflammation and neuroimmune activity. Safety and adverse effects will be monitored throughout given CBD's generally favorable profile.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with a long bone fracture of the lower limb (tibia, fibula, femur, metatarsals, and phalanges) or the upper limb (humerus, radius, ulna, metacarpals, and phalanges) treated to Sacre-Coeur Hospital in Montreal (HSCM) within one week of the accident
* Participants is between 18 and 70 years of age
* Patients with or without surgical procedures

Exclusion Criteria:

* Moderate/severe traumatic brain injury (TBI)
* Diagnosis of any of the following mental disorders as defined by the DSM-5: schizophrenia, intellectual disability, bipolar disorder, major depression, a diagnosed and untreated sleep disorders
* History of alcohol or opioid misuse/abuse, as defined by the DSM-5
* Evidence of severe renal (stage 4 or 5) or hepatic impairment (Child B or C)
* Pregnant or lactating women, women of childbearing potential who are not using medically accepted forms of contraception (e.g., condoms, oral contraceptive or intrauterine device), or women who are actively planning on becoming pregnant
* History of adverse reactions to cannabis
* Patients taking warfarin, sildenafil, valproate or under opioids treatment prior to the injury
* Patients experiencing on average mild-to-absent pain in the last 24h preceding recruitment (as per a score \<30 on a 0-100mm Visual Analogue Scale (VAS))
* Transport business drivers and heavy machinery operators
* A diagnosis of chronic pain, bone pathology (e.g., osteoporosis) or chronic inflammatory disease (e.g., rheumatoid arthritis, arthritis, psoriasis)
* Not having French or English as a spoken language
* A weighted MoCA score of less than 24
* Regular cannabis use more than 5 times a week

Where it's running

• Hôpital Sacré-Coeur de Montréal
  Montreal, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Louis De Beaumont, PhD
• Email: louis.de.beaumont@umontreal.ca
• Phone: 514-338-2222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.