Recruiting
Phase 2

Cannabidiol

Sponsor:

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Code:

NCT06448923

Conditions

Fracture

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Cannabidiol

Cannabidiol

Placebo

Study Details

Brief summary:

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

Fracture

Study ID

NCT06448923

Start date

Jun 1, 2025

Status verified date

Jul, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Pregnant or lactating women, women of childbearing potential who are not using medically accepted forms of contraception (e.g., condoms, oral contraceptive or intrauterine device), or women who are actively planning on becoming pregnant
  • History of adverse reactions to cannabis
  • Patients taking warfarin, sildenafil, valproate or under opioids treatment prior to the injury
  • Patients experiencing on average mild-to-absent pain in the last 24h preceding recruitment (as per a score <30 on a 0-100mm Visual Analogue Scale (VAS))
  • Transport business drivers and heavy machinery operators
  • A diagnosis of chronic pain, bone pathology (e.g., osteoporosis) or chronic inflammatory disease (e.g., rheumatoid arthritis, arthritis, psoriasis)
  • Not having French or English as a spoken language
  • A weighted MoCA score of less than 24
  • Regular cannabis use more than 5 times a week

Study Design

Enrollment

225 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low CBD dose

Participants will receive 25 mg orally twice daily during a meal for a month

experimental: Moderate CBD dose

Participants will receive 50 mg orally twice daily during a meal for a month

placebo comparator: Placebo

Participants will receive matching placebo orally twice daily during a meal for a month

Interventions

Cannabidiol

25 mg of CBD tablets twice daily

Cannabidiol

50 mg of CBD tablets twice daily

Placebo

Matching placebo tablets twice daily

Primary outcome measure

  • Change From Baseline on Pain Intensity Rating on a Visual Analog Scale (VAS) at Week 4 [ Time Frame: Baseline and 4 weeks ]

Central Contacts and Locations

Central contacts

Louis De Beaumont, PhD

514-338-2222louis.de.beaumont@umontreal.ca

Locations

Hôpital Sacré-Coeur de Montréal

Recruiting

Montreal, Quebec, Canada, H4J 1C5

Contacts

Amélie Apinis-Deshaies Research Coordinator

514-338-2222amelie.apinis-deshaies.cnmtl@ssss.gouv.qc.ca

More Information

Sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Last update posted

Jul 30, 2025

Last verified

Jul, 2025

Keywords

  • Cannabidiol
  • Trauma
  • Pain
  • Inflammation
  • Fracture
  • Orthopaedic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal on 2025-07-30.