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Cannabidiol for Knee Surgery Pain
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 2 trial • 13 Patients • NCT02818777Trial Design
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Who is running the clinical trial?
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- I am taking Coumadin.I have been diagnosed with a condition like rheumatoid arthritis or multiple sclerosis.I am scheduled for knee replacement surgery on both knees with approved surgeons.You have been using opioid pain medication for more than three months.I have a history of or currently have a major psychiatric illness.I am currently taking medication for depression or anxiety.You have a history of drug or alcohol abuse.I am in good or mild systemic disease state according to ASA.You have used or eaten hemp seeds or hemp oil in any way in the last 30 days.You have had seizures in the past.I do not speak English.You have used marijuana or related products in the last 3 months.I am currently taking valproate or clobazam.I am not allergic to cannabinoids, sesame oil, sucralose, or strawberry flavor.I am allergic or cannot tolerate key parts of the study treatment.You have a medical condition that is classified as ASA 3 or higher.I weigh less than 40kg.I will be undergoing surgery with general anesthesia.I am currently taking oral steroids.I am taking high doses of steroids for stress.I have a severe heart condition.My liver or kidney function is severely impaired.I am between 18 and 75 years old.
- Group 1: Ora-sweet SF
- Group 2: 400mg cannabidiol
- Group 3: 800mg cannabidiol
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
Is the study recruiting seniors for participation?
"The eligibility criteria for this trial stipulates that participants should be of age 18 and under 70."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
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