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Cannabinol for Knee Replacement Surgery (COPE Trial)

Phase 2 & 3
Waitlist Available
Led By Amit Atrey, MD
Research Sponsored by Unity Health Toronto
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 2 weeks after total knee replacement
Awards & highlights

Summary

Total knee replacement is a major and painful orthopaedic (joint and bone) surgery where the knee joint is replaced with an artificial joint. It is an effective and successful procedure to treat severe knee arthritis and reduce pain, but many patients report intense pain after the surgery. Postoperative pain control is predominated by opioids (morphine-based drugs). While opioids are effective to manage the pain, they can have acute and chronic complications, including confusion, nausea, vomiting, constipation and high risk of addiction. Medical cannabis is an effective and safe alternative for pain treatment. Recent studies showed that patients have reported a reduction in opioid usage when taking cannabis as a substitute for pain relief. This study aims to investigate whether adding medical cannabis (cannabidiol - CBD) treatment will decrease the amount of opiates needed in the first 2 weeks after knee replacement compared to a group given placebo.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks after total knee replacement
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks after total knee replacement for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Opioid consumption
Secondary outcome measures
Health status and quality of life
Narcotics
Oxford knee score
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Medical CannabisExperimental Treatment1 Intervention
Drug: Cannabidiol
Group II: PlaceboPlacebo Group1 Intervention
Placebo comparator
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabinol
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
549 Previous Clinical Trials
450,854 Total Patients Enrolled
Amit Atrey, MDPrincipal InvestigatorUnity Health Toronto
3 Previous Clinical Trials
582 Total Patients Enrolled
~41 spots leftby Sep 2025