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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
Must not have
Revision TKA
Severe cardio-respiratory disease (For operationalizing: ASA 4/NYHA 4)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-48 hours, 2-weeks, 6-weeks, 3-months and 6-months
Awards & highlights
Pivotal Trial

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am scheduled for or have had a revision of my knee replacement.
Select...
I do not have severe heart or lung disease.
Select...
I have had knee replacement surgery on both knees.
Select...
My knee pain is not due to chronic conditions like fibromyalgia.
Select...
I am not allergic to cannabis or its derivatives.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-48 hours, 2-weeks, 6-weeks, 3-months and 6-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-48 hours, 2-weeks, 6-weeks, 3-months and 6-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Persistent post-surgical pain (PPSP)
Secondary study objectives
Anxiety and depression
Insomnia
Mental function
+6 more
Other study objectives
Feasibility - compliance
Feasibility - recruitment
Feasibility - retention

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
377 Previous Clinical Trials
339,889 Total Patients Enrolled
2 Trials studying Osteoarthritis
233 Patients Enrolled for Osteoarthritis
McMaster UniversityLead Sponsor
917 Previous Clinical Trials
2,616,213 Total Patients Enrolled
20 Trials studying Osteoarthritis
901,135 Patients Enrolled for Osteoarthritis
St. Joseph's Healthcare HamiltonOTHER
202 Previous Clinical Trials
26,885 Total Patients Enrolled
1 Trials studying Osteoarthritis
64 Patients Enrolled for Osteoarthritis
Vahid Ashoorion, MD, PhDPrincipal InvestigatorMcMaster University
Jason W Busse, DC, PhDPrincipal InvestigatorMcMaster University
1 Previous Clinical Trials
25 Total Patients Enrolled
Anthony Adili, MD, P.EngPrincipal InvestigatorMcMaster University

Media Library

MPL-001 (CBD: THC 25:1) Clinical Trial Eligibility Overview. Trial Name: NCT03825965 — Phase 3
Osteoarthritis Research Study Groups: MPL-001 (CBD: THC 25:1), Placebo
Osteoarthritis Clinical Trial 2023: MPL-001 (CBD: THC 25:1) Highlights & Side Effects. Trial Name: NCT03825965 — Phase 3
MPL-001 (CBD: THC 25:1) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03825965 — Phase 3
~15 spots leftby Dec 2025
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