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Cannabinoid

Pre - and post-operative CBD for Osteoarthritis (CORK Trial)

Phase 2

Recruiting

Led By Kevin F Boehnke

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-op days 8-36

Awards & highlights

CORK Trial 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.Check my eligibility

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.See study design

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.

CORK Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My main diagnosis is knee osteoarthritis.

Select...

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

CORK Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-op days 8-36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-op days 8-36

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Total postoperative opioid consumption (measured in oral morphine equivalents) during the 28 days after surgery

Secondary outcome measures

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

Change in Interleukin-6 (IL-6) levels in the blood (University of michigan site only)

Frequency of deaths due to any cause

+10 more

CORK 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH

484 Previous Clinical Trials

1,086,465 Total Patients Enrolled

51 Trials studying Osteoarthritis

46,981 Patients Enrolled for Osteoarthritis

Chad BrummettLead Sponsor

Kevin F BoehnkePrincipal InvestigatorUniversity of Michigan

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this investigation currently open?

"Apologies for the confusion. According to the information available on clinicaltrials.gov, this particular study is currently not seeking participants. It was initially posted on February 1st, 2024 and last updated on January 22nd, 2024. However, there are presently 421 other active clinical trials actively recruiting patients at this time."

Answered by AI

What is the level of safety associated with administering CBD to patients before and after surgical procedures?

"Based on the Power team's evaluation, the safety of pre- and post-operative CBD is assigned a score of 2. As this trial falls under Phase 2, there is existing data supporting its safety but no evidence yet regarding its effectiveness."

Answered by AI