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CBD for Persistent Post-Surgical Pain After Knee Replacement
Phase 3
Recruiting
Led By Vahid Ashoorion, MD, PhD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-48 hours, 2-weeks, 6-weeks, 3-months and 6-months
Awards & highlights
Study Summary
This trial will assess whether adding CBD to usual care before and after surgery can reduce the rate of persistent post-surgical pain after total knee replacement.
Who is the study for?
This trial is for adults over 18 who are having knee replacement surgery and can understand English. They must be able to follow the study's steps and not have other chronic pain conditions, severe heart/lung disease, substance use disorders, or allergies to cannabis. Pregnant or breastfeeding individuals cannot participate.Check my eligibility
What is being tested?
The study tests if a CBD dominant oil (MPL-001) reduces long-term pain after knee surgery compared to a placebo oil. Participants will be randomly assigned to one of these two options and monitored for six months to see how well they do with their usual care plus the test product.See study design
What are the potential side effects?
While specific side effects aren't listed here, CBD products may cause tiredness, changes in appetite or weight, diarrhea, and sometimes mood changes. THC can lead to feeling 'high', but since it's much less than CBD in this mix, that effect might be minimal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24-48 hours, 2-weeks, 6-weeks, 3-months and 6-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-48 hours, 2-weeks, 6-weeks, 3-months and 6-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Persistent post-surgical pain (PPSP)
Secondary outcome measures
Anxiety and depression
Insomnia
Mental function
+6 moreOther outcome measures
Feasibility - compliance
Feasibility - recruitment
Feasibility - retention
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MPL-001 (CBD: THC 25:1)Experimental Treatment1 Intervention
125mg CBD/5 mg THC oil for oral use
Group II: PlaceboPlacebo Group1 Intervention
Visually identical placebo (medium chain triglyceride oil)
Find a Location
Who is running the clinical trial?
Hamilton Health Sciences CorporationOTHER
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300,961 Total Patients Enrolled
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McMaster UniversityLead Sponsor
884 Previous Clinical Trials
2,598,276 Total Patients Enrolled
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901,130 Patients Enrolled for Osteoarthritis
St. Joseph's Healthcare HamiltonOTHER
196 Previous Clinical Trials
25,504 Total Patients Enrolled
1 Trials studying Osteoarthritis
64 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for or have had a revision of my knee replacement.I am 18 or older and will have a total knee replacement.My pre-surgery consultation is within 4 weeks of my surgery date.I do not have severe heart or lung disease.You have a problem with drugs or alcohol according to specific guidelines for diagnosing substance use disorders.I have had knee replacement surgery on both knees.My knee pain is not due to chronic conditions like fibromyalgia.I am not allergic to cannabis or its derivatives.
Research Study Groups:
This trial has the following groups:- Group 1: MPL-001 (CBD: THC 25:1)
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA released any guidance on CBD usage?
"There is some evidence that CBD is effective, and it has been studied multiple times, so it received a score of 3."
Answered by AI
Is there precedent for CBD as a medication?
"As of now, 83 clinical trials for Cannabidiol (CBD) are ongoing. Of these, 18 are in Phase 3. The numerous studies for Cannabidiol (CBD) have their origins in Ribeirao Preto, Sao Paulo, but expanded to 311 locations."
Answered by AI
Who else is applying?
What site did they apply to?
St. Michael's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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