Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
ID06448923

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

225

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

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

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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.

10 outpatient visits

Trial Site Locations

Total: 1 location

1

Hôpital Sacré-Coeur de Montréal

Montreal, Quebec, Canada, H4J 1C5

Actively Recruiting

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Research Team

L

Louis De Beaumont, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

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...

https://pubmed.ncbi.nlm.nih.gov/39979051