Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448923
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-28
Brief Title:
Cannabidiol After Multi-Trauma for Pain and Opioid Therapy
Sponsor:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de lile de Montreal
Organization:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de lile de Montreal
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAM-POT
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
Detailed Description:
The level of pain in the acute phase after injury is a predictor of the development of chronic pain Chronic pain is defined as pain that persists for more than 3 months post-accident and impairs functional recovery Mechanistically it has been shown that acute nonspecific inflammation triggered after peripheral injury results in the continuous release of proinflammatory cytokines that weaken the blood-brain barrier facilitating the entry of toxins that can invade the central nervous system CNS The resulting sustained inflammation of the CNS plays an important role in establishing the maladaptive plasticity process underlying pain chronification Cannabidiol CBD a component of cannabis devoid of addictive or psychotropic effects stands out as a potential therapeutic agent given its analgesic and anti-inflammatory properties as well as its potential to enhance the biomechanical properties of bone healing Given the excellent safety profile of CBD and its inhibitory effects on microglial activity the primary mechanism of neuroinflammation and pain CBD has the potential to promote acute pain relief while reducing reliance on addictive opioid treatments hence facilitating recovery in trauma patients
This study is a randomized placebo controlled human pilot clinical trial evaluating the effects of two doses low and moderate of CBD vs placebo on pain after orthopaedic trauma
Risks of adverse effects are considered low given the demonstrated excellent safety profile of CBD CBD was also shown to accentuate opioid analgesic effects thus reducing required opioid doses for patient comfort The most likely adverse events associated with CBD in adult patients include somnolence fatigue drowsiness and decreased appetite Access to on-duty emergency physicians at the recruiting site will be provided during the entire treatment duration
A 30 percent relative pain intensity reduction on the Visual Analog Scale VAS expected response of 50 percent or more in the CBD group and expected 20 percent in the placebo group has been used extensively to reflect clinically significant pain relief in clinical trials Based on a Fishers exact test a sample size of 168 participants 3 groups of 56 will be required to reach a power of 80 percent to detect a statistically significant difference in the proportion of patients who reaches 30 percent pain reduction between the CBD groups and placebo at 1-month post-injury assuming a dropout rate of 20 percent and a significance level of 5 percent These parameters are taken from a successful randomised placebo-controlled clinical trial using Sativex in treating 125 neuropathic pain patients
Our group has ensured the feasibility of conducting such a pilot clinical trial in multi-trauma patients with the recruitment of 110 patients in less than 18 months to take part in a 10-session outpatient treatment trial A partnership with Canadian company EmpowerPharm will enable the use of pharmaceutical-grade synthetic CBD samples and identical placebos The pharmacokinetic profile of the CBD product has been established
This study is a randomized placebo controlled human pilot clinical trial evaluating the effects of two doses low and moderate of CBD vs placebo on pain after orthopaedic trauma
Risks of adverse effects are considered low given the demonstrated excellent safety profile of CBD CBD was also shown to accentuate opioid analgesic effects thus reducing required opioid doses for patient comfort The most likely adverse events associated with CBD in adult patients include somnolence fatigue drowsiness and decreased appetite Access to on-duty emergency physicians at the recruiting site will be provided during the entire treatment duration
A 30 percent relative pain intensity reduction on the Visual Analog Scale VAS expected response of 50 percent or more in the CBD group and expected 20 percent in the placebo group has been used extensively to reflect clinically significant pain relief in clinical trials Based on a Fishers exact test a sample size of 168 participants 3 groups of 56 will be required to reach a power of 80 percent to detect a statistically significant difference in the proportion of patients who reaches 30 percent pain reduction between the CBD groups and placebo at 1-month post-injury assuming a dropout rate of 20 percent and a significance level of 5 percent These parameters are taken from a successful randomised placebo-controlled clinical trial using Sativex in treating 125 neuropathic pain patients
Our group has ensured the feasibility of conducting such a pilot clinical trial in multi-trauma patients with the recruitment of 110 patients in less than 18 months to take part in a 10-session outpatient treatment trial A partnership with Canadian company EmpowerPharm will enable the use of pharmaceutical-grade synthetic CBD samples and identical placebos The pharmacokinetic profile of the CBD product has been established
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None