← Back to Search

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 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

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 more
Other 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
368 Previous Clinical Trials
300,961 Total Patients Enrolled
2 Trials studying Osteoarthritis
233 Patients Enrolled for Osteoarthritis
McMaster UniversityLead Sponsor
884 Previous Clinical Trials
2,598,276 Total Patients Enrolled
20 Trials studying Osteoarthritis
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

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

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
~9 spots leftby Aug 2024