Cannabidiol for pain relief after traumatic fractures and to reduce opioid use
Effects of an Acute 1-month Cannabidiol Treatment on Pain and Inflammation After a Long Bone Fracture: a Triple-blind Randomized, Placebo Controlled Clinical Trial
We will test whether taking cannabidiol twice daily for one month can reduce pain and opioid use in adults 18–70 treated for recent long-bone fractures at Sacré-Coeur Hospital.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06448923 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–70 with a recent (within one week) long-bone fracture treated at Hôpital Sacré-Coeur de Montréal, with or without surgery, who meet medical eligibility criteria are ideal candidates.
Not a fit: Patients with moderate/severe traumatic brain injury, certain DSM-5 psychiatric diagnoses, active alcohol or opioid misuse, severe renal or hepatic impairment, pregnant or non-contracepting women, or those treated outside the Montreal site are unlikely to be eligible or benefit from this protocol.
Why it matters
Potential benefit: If successful, CBD could provide safer short-term pain relief after fractures, reduce reliance on opioids, and lower the risk of pain becoming chronic.
How similar studies have performed: Preclinical work and small human studies suggest CBD has analgesic and anti-inflammatory effects and may reduce opioid use in some settings, but randomized clinical evidence specifically for acute fracture pain is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Montreal, Quebec
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.