Cannabidiol After Multi-Trauma for Pain and Opioid Therapy (NCT06448923)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (14 items).
Location: Hôpital Sacré-Coeur de Montréal — Montreal, Quebec
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Hôpital Sacré-Coeur de Montréal — Montreal, Quebec
📞 Contact the Study Coordinator
Phone: (514) 338-2222
Email: louis.de.beaumont@umontreal.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Fracture
- The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care — Hamilton, Ontario
- Buprenorphine for Analgesia in Older Adults With Acute Fractures in the Emergency Department — Camden, New Jersey
- Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation — Edmonton, Alberta
- Pediatric Orthopaedic Implant Safety & Efficacy — Vancouver, British Columbia
Explore by condition: All Fracture clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.