Cannabidiol After Multi-Trauma for Pain and Opioid Therapy

ConditionFracture
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

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

Treatment groups

225 Participants
are divided into 3 treatment groups