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
Led by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Updated on 2025-07-30
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What this Trial Is About
Researchers are investigating the potential benefits and safety of acute Cannabidiol (CBD) treatment for pain relief following long bone fractures. This trial aims to evaluate how two daily doses of CBD, compared to a placebo, affect pain symptoms, inflammation markers, opioid use, quality of life, sleep quality, mood, cognition, and orthopedic function. The study focuses on adults aged 18 to 70 who have suffered fractures of the upper or lower limbs and explores CBD's potential to reduce chronic pain development and reliance on opioids after trauma.
Participants will be randomly assigned to receive either a low dose of 25 mg CBD twice daily, a moderate dose of 50 mg CBD twice daily, or a matching placebo twice daily, all taken orally with meals for one month. The trial is triple-blinded and placebo-controlled to ensure unbiased results. This controlled treatment period is followed by assessments at 4 weeks and 3 months to monitor changes in pain, inflammation, opioid use, and other health-related outcomes.
Study participants will undergo multiple evaluations including pain intensity ratings using the Visual Analog Scale (VAS), Brief Pain Inventory, and various cognitive and mood assessments. Researchers will also monitor opioid usage, inflammation blood markers, orthopedic function, sleep quality, depression, anxiety, and cognitive function at baseline, 4 weeks, and 3 months. The total study duration for each participant includes one month of treatment plus follow-up assessments up to 3 months, with safety monitoring throughout the trial.
CONDITIONS
Brief Title
Cannabidiol After Multi-Trauma for Pain and Opioid Therapy
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
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 within one week of the accident
Participants aged between 18 and 70 years
Patients with or without surgical procedures
You will not qualify if you...
Moderate or severe traumatic brain injury (TBI)
Diagnosis of schizophrenia, intellectual disability, bipolar disorder, major depression, or untreated sleep disorders
History of alcohol or opioid misuse or abuse
Severe kidney (stage 4 or 5) or liver impairment (Child B or C)
Pregnant or breastfeeding women, women not using medically accepted contraception, or planning pregnancy
History of adverse reactions to cannabis
Taking warfarin, sildenafil, valproate, or opioid treatment before injury
Mild or absent pain in the last 24 hours before recruitment (VAS score below 30)
Transport business drivers and heavy machinery operators
Diagnosis of chronic pain, bone diseases like osteoporosis, or chronic inflammatory diseases such as rheumatoid arthritis or psoriasis
Not fluent in French or English
Cognitive assessment (MoCA) score below 24
Regular cannabis use more than 5 times a week
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 1 month
Participants receive either low dose cannabidiol (25 mg twice daily), moderate dose cannabidiol (50 mg twice daily), or placebo tablets twice daily with meals for one month to assess effects on pain and inflammation after injury.
Impact of an acute 1-month cannabidiol treatment on pain and inflammation after a long bone fracture: a triple-blind randomised, placebo-controlled, clinical trial protocol.
Daphnée Brazeau, Amelie A Deshaies, David Williamson...