Cannabidiol After Multi-Trauma for Pain and Opioid Therapy

Launched by CENTRE INTEGRE UNIVERSITAIRE DE SANTE ET SERVICES SOCIAUX DU NORD DE L'ILE DE MONTREAL · Jun 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of Cannabidiol (CBD), a compound found in cannabis, on pain relief in patients who have suffered from fractures and other injuries. The goal is to see if CBD can help reduce pain and improve the overall quality of life for these patients, especially when compared to traditional pain medications like opioids. The trial will involve participants receiving either CBD or a placebo (a treatment with no active ingredient) for one month. Researchers will also look at how CBD affects inflammation, sleep quality, mood, and physical function.

To participate, individuals must be between 18 and 70 years old and have recently been admitted to the Hopital du Sacre-Coeur de Montreal with a long bone fracture. They should be within seven days of their injury and able to provide consent to join the study. However, certain people are not eligible, such as those with severe brain injuries, certain mental health disorders, or those who misuse substances like alcohol or opioids. Participants can expect regular check-ins during the study to monitor their pain levels and overall health, contributing important information that could help others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients admitted to the Hopital du Sacre-Coeur de Montreal (HSCM), within 7 days of the accident for a long bone fracture with or without mTBI
• • Subject has provided informed consent
• • Subject is between 18 and 70 years old
• Exclusion Criteria:
• • Moderate/severe traumatic brain injury (TBI)
• • Diagnosis of any of the following mental disorders as defined by the DSM-5: schizophrenia, intellectual deficiency, bipolar disorder, major depression, undiagnosed and untreated sleep disorders
• • History of alcohol or opioid misuse/abuse
• • Evidence of severe renal (stage 4 or 5) or hepatic impairment (stage B or C)
• • Pregnant or lactating women, women of childbearing potential who are not using medically accepted forms of contraception, or women who are 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 (osteoporosis) or chronic inflammatory disease (rheumatoid arthritis, arthritis, psoriasis)
• • Not have French or English as a spoken language
• • A weighted MoCA score of less than 24
• • Regular cannabis use of more than 5 times a week