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Cannabinoid

Cannabidiol for Knee Surgery Pain

Phase 4
Recruiting
Led By Alexandra Sideris, PhD
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled for same-day bilateral total knee replacements with participating surgeons
American Society of Anesthesiologists (ASA) Physical Status 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at hospital discharge to pod7 and at 3 months
Awards & highlights

Study Summary

This trial will study the effects of Epidiolex, a cannabidiol medication, on patients undergoing a common knee surgery. The goal is to see if Epidiolex can help reduce pain and the need for opioids.

Who is the study for?
This trial is for adults aged 18-75 scheduled for bilateral knee replacements who are generally healthy (ASA Physical Status 1 or 2). It's not for those with severe health issues, recent cannabis use, chronic opioid use, certain medication usage, or major psychiatric history.Check my eligibility
What is being tested?
The study tests Epidiolex®, an FDA-approved oral CBD solution. Participants will receive either a placebo, 400mg or 800mg of Epidiolex® to see if it reduces opioid need and pain after knee surgery while checking its safety and effects on body inflammation.See study design
What are the potential side effects?
While the side effects aren't detailed here, CBD can typically cause drowsiness, changes in appetite/weight, diarrhea, fatigue. The trial will monitor tolerability and any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for knee replacement surgery on both knees with approved surgeons.
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I am in good or mild systemic disease state according to ASA.
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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at hospital discharge to pod7 and at 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at hospital discharge to pod7 and at 3 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
Cumulative Opioid Usage in First 72 hours Postoperatively
Secondary outcome measures
Anxiety levels
Blinding Assessment
Brief Pain Inventory Short Form
+13 more

Side effects data

From 2017 Phase 2 trial • 13 Patients • NCT02818777
85%
Diarrhea
69%
Somnolence
62%
Fatigue
38%
Elevated liver function tests
31%
Weight gain
23%
Dizziness
23%
Abdominal pain
15%
weight loss
15%
nausea
15%
anorexia
15%
headache
15%
increased appetite
8%
vomiting
8%
flatulence
8%
gastroesophageal reflux
8%
allergic reaction
8%
spasm
8%
fever
8%
weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cannabidiol

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 800mg cannabidiolExperimental Treatment1 Intervention
Group II: 400mg cannabidiolExperimental Treatment1 Intervention
Group III: Ora-sweet SFPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cannabidiol
2010
Completed Phase 3
~150

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor
242 Previous Clinical Trials
61,866 Total Patients Enrolled
Alexandra Sideris, PhDPrincipal InvestigatorHospital for Special Surgery, New York
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04749628 — Phase 4
Opioid Use Disorder Research Study Groups: Ora-sweet SF, 400mg cannabidiol, 800mg cannabidiol
Opioid Use Disorder Clinical Trial 2023: cannabidiol Highlights & Side Effects. Trial Name: NCT04749628 — Phase 4
cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04749628 — Phase 4

Frequently Asked Questions

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

Has cannabidiol been explored in any other scientific investigations?

"Currently, 79 studies concerning cannabidiol are in progress and 16 of these have reached the third stage. Several trials for this compound originate from Ribeirao Preto, Sao Paulo while 290 testing centres around the world are currently running clinical trials on it."

Answered by AI

Is the study recruiting seniors for participation?

"The eligibility criteria for this trial stipulates that participants should be of age 18 and under 70."

Answered by AI

What qualifications are necessary for potential participants of this trial?

"We require 36 individuals, ranging in age from 18 to 70 years old and suffering with postoperative pain. Other conditions for participation include being an ASA Physical Status 1 or 2 patient who has been scheduled for a bilateral total knee replacement surgery performed by one of the participating surgeons."

Answered by AI

Is this research endeavor still accessible to those who wish to participate?

"Correct. According to clinicaltrials.gov, this medical trial is still open for applicants and was originally posted on September 24th 2020 before being updated most recently on May 5th 2022. In total, 36 individuals need to be enrolled at a single site."

Answered by AI

Are there any safety considerations associated with medicating using cannabidiol?

"The safety of cannabidiol has been validated in a Phase 4 trial, so it was given the highest score of 3 on our assessment scale."

Answered by AI

What is the current enrollment capacity for this research initiative?

"Affirmative. According to the information hosted on clinicaltrials.gov, this research study is still accepting participants and was originally posted in September 2020 with a recent update being made in May 2022. The trial requires 36 patients from one location."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Hospital for Special Surgery
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’m interested in this study.
PatientReceived no prior treatments
~2 spots leftby May 2024