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New treatment option for Fracture
Official title Cannabidiol After Multi-Trauma for Pain and Opioid Therapy
ClinicalTrials.gov ID: NCT06448923
What this study is testing
What is Cannabidiol?
Cannabidiol is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for fracture.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Patients with a long bone fracture of the lower limb (tibia, fibula, femur, metatarsals, and phalanges) or the upper limb (humerus, radius, ulna...
- Participants is between 18 and 70 years of age
- Patients with or without surgical procedures
You likely can't join 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...
- 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...
- History of adverse reactions to cannabis
See the full eligibility 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...
- Participants is between 18 and 70 years of age
- Patients with or without surgical procedures
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.