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Cannabinoid

Cannabidiol for Pain Management After Knee Replacement (CORK Trial)

Phase 2

Recruiting

Led By Chad Brummett, MD

Research Sponsored by Chad Brummett

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary diagnosis of osteoarthritis of the surgical knee

Scheduled for surgery: primary total knee arthroplasty

Must not have

Severe physical impairment or clinically significant illness (e.g., blindness, paraplegia)

High daily preoperative opioid dose

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 8-36 (post-surgery)

Summary

This trial aims to investigate how taking cannabidiol (CBD) every day affects the need for opioid pain medication and other symptoms after knee replacement surgery. The researchers want to determine if CBD can be

Who is the study for?

This trial is for adults who have had a knee replacement surgery due to osteoarthritis and are in need of pain management. Participants should not be currently using CBD or cannabis products, must not have allergies to cannabinoids, and should not be on certain medications that could interact with CBD.

What is being tested?

The study is testing whether taking cannabidiol (CBD) orally can reduce the need for opioid painkillers after knee surgery. Patients will either receive Epidiolex, a CBD solution, or a placebo without knowing which one they're getting.

What are the potential side effects?

Possible side effects of Epidiolex include drowsiness, diarrhea, appetite changes, and possibly liver issues. It's important to monitor any symptoms and report them to the healthcare team.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My main diagnosis is knee osteoarthritis.

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I am scheduled for a first-time knee replacement surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe physical condition like blindness or paralysis.

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I take a high dose of painkillers daily before surgery.

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I am not taking medication that strongly affects certain liver enzymes.

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I cannot use opioids for pain due to severe side effects or have decided not to use them after surgery.

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I am having or have had a knee replacement on both knees or a redo.

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I am currently taking valproate, clobazam, or warfarin.

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I have been diagnosed with liver cirrhosis.

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I have diabetes that is not well-controlled.

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I have active hepatitis.

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I do not have severe heart problems like unstable chest pain or heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 8-36 (post-surgery)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 8-36 (post-surgery)

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 8-36 (post-surgery) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Anxiety based on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29+2 profile v2.1

Percentage of participants that meet or exceed the thresholds of liver enzymes

Sleep disturbance on the PROMIS-29+2 v.2.1

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Pre-operative placebo plus post-operative CBDExperimental Treatment2 Interventions

Participants will take placebo prior to surgery days 1-7, then days 8-36 participants will take CBD 300 milligrams (150mg twice a day \[b.i.d.\])

Group II: Pre-operative CBD plus post-operative placeboExperimental Treatment2 Interventions

Participants will take CBD 300 milligrams (mg) /day prior to surgery on days 1-7 (150mg twice a day \[b.i.d.\]), then days 8-36 will take placebo twice a day \[b.i.d.\]

Group III: Pre - and post-operative CBDExperimental Treatment1 Intervention

Participants will take 300 milligrams (mg)/day on days 1-36 (150mg twice a day \[b.i.d.\])

Group IV: Pre- and post-operative placeboPlacebo Group1 Intervention

Participants will take placebo on days 1-36 twice a day \[b.i.d.\]

0 / 12Eligibility criteria met