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.
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
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)
Parallel
Cannabidiol
Drug25 mg of CBD tablets twice daily
Cannabidiol
Drug50 mg of CBD tablets twice daily
Placebo
DrugMatching placebo tablets twice daily
Change From Baseline on Pain Intensity Rating on a Visual Analog Scale (VAS) at Week 4
VAS pain intensity will be collected at baseline (before the start of treatment), twice a week during treatment, 24 hours after the end of treatment and at the 3-month follow-up. The VAS is a 100 mm line with anchor words ranging from "no pain" to "worst pain imaginable". Participants will be asked to place an intersecting mark along the line to indicate their pain intensity at the specific time of the test.
Response Rate - 50 Percent or Greater Reduction in Pain Intensity on a Visual Analog Scale (VAS)
The response rate was defined as the number of participants with a 50 percent or greater reduction in VAS pain score from baseline to end of treatment. The VAS is a 100 mm line with anchor words ranging from "no pain" to "worst pain imaginable".
Change in Pain Rating on the Brief Pain Inventory Short Form (BPI-sf) Between Interventions
The Brief Pain Inventory short form (BPI-sf) is a 9-item self-reported questionnaire assessing for the presence, intensity, and location(s) of pain, as well as perceived efficacy of pain relief treatment, and pain interference with activities of daily living. Item scores range from 0-10. The lower the score, the better the subject's pain.
Change in Blood Level Inflammation Over Time and Between Interventions
Blood levels of pro-inflammatory cytokines including interleukins (IL-6, IL-10) and tumor necrosis factor-alpha (TNF-α) will be collected and quantified.
Opioid Usage Monitoring
Opioid usage will be collected from daily medication diary for the first month and from number of prescription refills for months 2 and 3.
Pain catastrophization using the Pain Catastrophizing Scale
The Pain Catastrophizing Scale is a 15-item self-report questionnaire assessed with Likert Scales. The overall score has a range of 0-52, with higher scores representing more severe symptoms.
Change in mTBI symptoms resolution using the Rivermead Post-Concussion Questionnaire (RPQ)
Only for participants diagnosed with mTBI related to the injury. The RPQ has a total possible score of 0-52, with higher scores indicative of worse outcomes.
Treatment Expectation using the Treatment Expectation Questionnaire (TEX-Q-F)
The Treatment Expectation Questionnaire is a 15-item questionnaire assessing the level of expectation towards treatment. The scale of the items ranges from 0 to 10. Higher scores indicate higher expectations.
Symptoms of Post-Traumatic Stress Disorder using the PTSD Checklist for DSM-5 (PCL-5) questionnaire
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure of the Diagnostic and Statistical Manual (DSM-5) symptoms of PTSD. Scores range from 0 to 80, with higher scores representing more severe symptoms of PTSD.
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