Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT06448923

Cannabidiol After Multi-Trauma for Pain and Opioid Therapy

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

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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 or upper limb treated at Sacre-Coeur Hospital 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
  • Diagnosis of schizophrenia, intellectual disability, bipolar disorder, major depression, or untreated sleep disorders
  • History of alcohol or opioid misuse or abuse
  • Severe kidney or liver impairment
  • Pregnant, breastfeeding, or women not using accepted contraception or planning pregnancy
  • History of adverse reactions to cannabis
  • Taking warfarin, sildenafil, valproate, or opioids before injury
  • Mild or absent pain in the 24 hours before recruitment (VAS score <30)
  • Employment as transport drivers or heavy machinery operators
  • Diagnosis of chronic pain, bone disease, or chronic inflammatory disease
  • Not speaking French or English
  • MoCA cognitive score less than 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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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

CONTACT

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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