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Cannabinoid
CBD for Knee Osteoarthritis
Phase 2 & 3
Recruiting
Led By Michael J Alaia, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients presenting with knee osteoarthritis (KL Grade II-III)
Male patients must be using an effective form of contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 84
Awards & highlights
Study Summary
This trial is testing if CBD ODTs can help treat pain and improve function in people with knee osteoarthritis.
Who is the study for?
Adults aged 40-75 with knee osteoarthritis (KL Grade II-III) and pain for at least three months can join. They must have a VAS score of ≥4, indicating moderate to severe pain, and use effective contraception if applicable. Excluded are those with mental impairments, extreme obesity (BMI > 35), liver or kidney issues, certain drug interactions, history of substance abuse or major psychiatric disorders.Check my eligibility
What is being tested?
The trial is testing whether CBD orally dissolving tablets can reduce pain and improve function in knee osteoarthritis patients compared to a placebo. Participants will not experience any 'high' as the treatment does not contain THC.See study design
What are the potential side effects?
Potential side effects of CBD may include tiredness, changes in appetite or weight, diarrhea, and sometimes mood changes like irritability or agitation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have moderate knee arthritis.
Select...
I am a male and I use effective birth control methods.
Select...
I am using two effective birth control methods as a pre-menopausal woman.
Select...
I am between 40 and 75 years old.
Select...
I have had knee pain for at least 3 months, on most days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 84
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 84
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain
Secondary outcome measures
Knee
Number of Patients Requiring Rescue Corticosteroid Use
Pain
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CBD GroupExperimental Treatment1 Intervention
The first cohort will take two 25mg cannabidiol (total dose: 50mg) Orally Disintegrating Tablets (CBD ODT) three times daily for a maximum dose of 150mg per day.
Group II: Placebo GroupPlacebo Group1 Intervention
Cohort 2 will receive the same instructions, but with the placebo Orally Disintegrating Tablets (ODT) instead.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol (CBD)
2021
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,535 Total Patients Enrolled
Orcosa Inc.UNKNOWN
1 Previous Clinical Trials
100 Total Patients Enrolled
Michael J Alaia, MDPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe kidney or liver problems.I am currently breastfeeding.I do not have major neurological disorders like dementia or epilepsy.I have moderate knee arthritis.My liver function is moderately or severely impaired.I am currently taking medications that affect liver enzyme activity.I have not had a stroke or heart attack in the last 3 months.I am a male and I use effective birth control methods.I am using two effective birth control methods as a pre-menopausal woman.I am between 40 and 75 years old.I haven't had knee injections (cortisone, PRP, hyaluronic acid) in the last 3 months.I am legally competent and mentally sound.I have a diagnosed inflammatory arthritis condition.I am over 75 years old.I am under 40 years old.I have a large buildup of fluid in my body.I am currently taking medications that strongly affect my liver enzymes.I am not taking strong CYP3A4 or CYP2C19 inducers together.I have thought about or have a history of thinking about suicide.I have a history of blood clotting issues or abnormal coagulation test results.I have had knee pain for at least 3 months, on most days.I am using two effective birth control methods if I am pre-menopausal.
Research Study Groups:
This trial has the following groups:- Group 1: CBD Group
- Group 2: Placebo Group
Awards:
This trial has 0 awards, including: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.
Knee Arthritis Patient Testimony for trial: Trial Name: NCT05020028 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment have an age limit? At what point do potential participants become too old to be included in the research?
"The age range that this clinical study is recruiting patients starts at 40 years old and finishes at 75 years old."
Answered by AI
Are patients still being accepted into this research program?
"Per the clinicaltrials.gov website, this clinical trial is actively recruiting patients. The study was originally posted on 6/22/2022 and has since been edited on 7/15/2022."
Answered by AI
How can I become a part of this clinical trial?
"This trial is looking for 100 patients that are 40-75 years old and have arthrosis. Other inclusion criteria include: pain in the knee for at least 3 months, a VAS score of 4 or higher, and being pre-menopausal (for female patients). Patients must also be using effective forms of contraception."
Answered by AI
Could you please explain what other research has looked into Cannabidiol (CBD)?
"Right now, 83 different clinical trials are underway for Cannabidiol (CBD). Of these, 18 have progressed to Phase 3. However, the majority of research locations for this treatment are in Ribeirao Preto, Sao Paulo. In total, 311 medical centres are running studies on CBD's efficacy."
Answered by AI
How many individuals are being included in this research project?
"Yes, this is an ongoing study that has updated their information on clinicaltrials.gov as of 7/15/2022. They are looking for 100 individuals to participate at 1 site."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I want to find a cure! Other drugs haven't worked. I have osteos arthritis in my right knee.
PatientReceived no prior treatments
How responsive is this trial?
Most responsive sites:
- NYU Langone Health: < 48 hours
Average response time
- < 2 Days
Typically responds via
Phone Call
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