Cannabidiol After Multi-Trauma for Pain and Opioid Therapy
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
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
225 participants
Jun 1, 2025
INTERVENTIONAL
Conditions
Summary
The aim of this project is to investigate the therapeutic potential and safety of acute Cannabidiol (CBD) treatment on longitudinal pain symptoms, and to assess potential interactions with pain mediators including opioids and sex on CBD treatment response. To this end, this research protocol proposes a comprehensive translational approach including a placebo-controlled randomized clinical trial comparing two daily doses of CBD treatment administered for one month on pain relief. This study will also compare intervention conditions on inflammation markers, participant quality of life, sleep quality, depression, anxiety, cognition and orthopaedic function.
Eligibility
Inclusion Criteria3
- 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 Criteria13
- 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
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Interventions
25 mg of CBD tablets twice daily
50 mg of CBD tablets twice daily
Matching placebo tablets twice daily
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06448923