Cannabidiol After Multi-Trauma for Pain and Opioid Therapy

NCT06448923 | Recruiting Phase 2

• 1 other identifier: 2025-2105
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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

Keywords

Cannabidiol; Trauma; Pain; Inflammation; Fracture; Orthopaedic

Outcome Measures

Primary Outcomes (1)

• Change From Baseline on Pain Intensity Rating on a Visual Analog Scale (VAS) at Week 4

  VAS pain intensity will be collected at baseline (before the start of treatment), twice a week during treatment, 24 hours after the end of treatment and at the 3-month follow-up. The VAS is a 100 mm line with anchor words ranging from "no pain" to "worst pain imaginable". Participants will be asked to place an intersecting mark along the line to indicate their pain intensity at the specific time of the test.

  Baseline and 4 weeks

Secondary Outcomes (16)

• Response Rate - 50 Percent or Greater Reduction in Pain Intensity on a Visual Analog Scale (VAS)

  4 weeks

• Change in Pain Rating on the Brief Pain Inventory Short Form (BPI-sf) Between Interventions

  4 weeks and 3 months

• Change in Blood Level Inflammation Over Time and Between Interventions

  Baseline, 4 weeks and 3 months

• Opioid Usage Monitoring

  Ongoing from baseline to 3 months

• Change in the Orthopaedic Function Using The Short Musculoskeletal Function Assessment (SMFA) Questionnaire Between Interventions

  4 weeks and 3 months

Other Outcomes (4)

• Pain catastrophization using the Pain Catastrophizing Scale

  Baseline

• Change in mTBI symptoms resolution using the Rivermead Post-Concussion Questionnaire (RPQ)

  Baseline, 4 weeks and 3 months

• Treatment Expectation using the Treatment Expectation Questionnaire (TEX-Q-F)

  Baseline

Study Arms (3)

Low CBD dose

EXPERIMENTAL

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

Drug: Cannabidiol

Moderate CBD dose

EXPERIMENTAL

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

Drug: Cannabidiol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Cannabidiol DRUG

25 mg of CBD tablets twice daily

Low CBD dose

Placebo DRUG

Matching placebo tablets twice daily

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hôpital Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

RECRUITING

Related Publications (1)

• Brazeau D, Deshaies AA, Williamson D, Bernard F, Arbour C, Pinard AM, Rouleau D, De Beaumont L. 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. BMJ Open. 2025 Feb 20;15(2):e092919. doi: 10.1136/bmjopen-2024-092919.

  PMID: 39979051 DERIVED

MeSH Terms

Conditions

Fractures, Bone; Wounds and Injuries; Pain; Inflammation

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Louis De Beaumont, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 7, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

CA (1)