About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Cannabidiol
- Cannabidiol
- Placebo