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Dronabinol for Pain Management after Total Knee Replacement
Phase 4
Waitlist Available
Led By Kethy Jules-Elysee, M.D.
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
Patients aged between 18-70 years old with osteoarthrosis scheduled for primary unilateral knee arthroplasty with a participating surgeon
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours post operative discharge, 48 hours post operative discharge, 3 months post operative discharge, 6 months post operative discharge
Awards & highlights
Study Summary
This trial will investigate whether the use of dronabinol, a cannabinoid, can reduce pain and the need for opioids following total knee arthroplasty.
Who is the study for?
This trial is for adults aged 18-70 undergoing knee replacement surgery who plan to use regional anesthesia. It's not for those with a BMI ≥40, chronic opioid users, severe systemic disease (ASA IV+), major mental health history, on certain medications like anticonvulsants or Coumadin, non-English speakers, under 18 or over 70 years old, using general anesthesia, with a history of seizures or revision surgery.Check my eligibility
What is being tested?
The study tests if Dronabinol reduces the need for opioids after knee surgery compared to a placebo. Participants are randomly assigned to receive either Dronabinol or placebo and will answer surveys about pain and nausea/vomiting. They'll also be monitored for oxygen levels and sleep quality to see if there's an impact on recovery milestones.See study design
What are the potential side effects?
Dronabinol may cause side effects such as dizziness, dry mouth, sleepiness or fatigue, mood changes, increased appetite and altered sensory perceptions. More serious but less common side effects include heart palpitations and low blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18-70 years old and scheduled for knee replacement due to osteoarthritis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours post operative discharge, 48 hours post operative discharge, 3 months post operative discharge, 6 months post operative discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours post operative discharge, 48 hours post operative discharge, 3 months post operative discharge, 6 months post operative discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Opioid Consumption 24-48 hours post-operatively
Secondary outcome measures
Cognitive assessment
DN4 score
Length of stay (hours)
+11 moreSide effects data
From 2019 Phase 4 trial • 72 Patients • NCT036043416%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gestational Age up to 10w0d - Placebo
Gestational Age up to 10w0d - Dronabinol
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DronabinolExperimental Treatment1 Intervention
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Group II: PlaceboPlacebo Group1 Intervention
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dronabinol 5mg Cap
2021
Completed Phase 4
~190
Find a Location
Who is running the clinical trial?
Hospital for Special Surgery, New YorkLead Sponsor
243 Previous Clinical Trials
59,250 Total Patients Enrolled
Kethy Jules-Elysee, M.D.Principal InvestigatorHospital for Special Surgery, New York
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not speak English.I am between 18-70 years old and scheduled for knee replacement due to osteoarthritis.I am taking Coumadin.I am currently taking Metronidazole.I am scheduled for surgery with specific regional anesthesia techniques.I am currently taking Disulfiram.My BMI is 40 or higher.You have been taking strong pain medications called opioids for more than 3 months before the surgery.I am taking medication for seizures.I am between 18 and 70 years old.I will be undergoing surgery with general anesthesia.I am scheduled for or have had a revision surgery.I have a history of seizures.I cannot have certain types of anesthesia due to health reasons.I am currently taking antidepressants.You have used cannabis or cannabinoids in the past three months.
Research Study Groups:
This trial has the following groups:- Group 1: Dronabinol
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who are the eligible participants for this research project?
"To be accepted into this research, participants have to meet the criteria of opioid use as well as being in the age range of 18-70. 110 individuals are slated for inclusion."
Answered by AI
How many individuals have chosen to participate in this experiment?
"Affirmative. As stated on clinicaltrials.gov, this research is looking for interested participants; it was initially posted in March 2021 and most recently updated in July 2022. The study requires 110 people to join at one medical site."
Answered by AI
Are there any vacancies for prospective participants in this clinical experiment?
"Data hosted on clinicaltrials.gov reveals that this experiment is actively seeking volunteers, as the trial was originally posted in March 2021 and updated lastly on July 14th of 2022."
Answered by AI
Is eligibility for this trial contingent upon age, specifically under 35 years old?
"As indicated by the qualifications for entry, individuals aged between 18 and 70 are eligible to participate. Additionally, 14 trials have been set up specifically for minors while 180 can accommodate seniors above 65 years old."
Answered by AI
Has the efficacy of Dronabinol 5mg Cap been tested in any other prior studies?
"Presently, 38 clinical trials for Dronabinol 5mg Cap are taking place with 6 of those studies in their final phase. The primary research site is based in Belmont, Massachusetts however 90 other locations are also conducting experiments on this medication."
Answered by AI
What medical applications is Dronabinol 5mg Cap typically employed for?
"Dronabinol 5mg Cap can assist those struggling with weight loss, inadequate response to conventional therapy, and pharmacotherapy."
Answered by AI
Is the 5mg capsule of Dronabinol a safe dosage for human use?
"The safety of Dronabinol 5mg Cap has been solidified by its Phase 4 status, thus our team at Power awarded it a score of 3."
Answered by AI
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