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Cannabidiol (CBD) for Knee Osteoarthritis

NYU Langone Health, New York, NY
Cannabidiol (CBD) +1 morePhase 2 & 3RecruitingLed by Michael J Alaia, MDResearch Sponsored by NYU Langone Health

Study Summary

This trial is testing if CBD ODTs can help treat pain and improve function in people with knee osteoarthritis.

Eligible Conditions
  • Knee Arthritis

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have been experiencing knee pain for at least three months, happening on most days during that time.
You have moderate to severe knee osteoarthritis.
You have moderate to severe pain, rated at least 4 out of 10 on a pain scale.
You have knee osteoarthritis that has been classified as grade II or III according to the Kellgren-Lawrence grading system.
You are experiencing pain rated 4 or higher on a visual analog scale (VAS).
You have been experiencing knee pain for at least three months, happening at least half of the time during that period.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 84
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 84 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Secondary outcome measures
Number of Patients Requiring Rescue Corticosteroid Use

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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol (CBD)
Completed Phase 1

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,335 Previous Clinical Trials
795,016 Total Patients Enrolled
Orcosa Inc.UNKNOWN
1 Previous Clinical Trials
100 Total Patients Enrolled
Michael J Alaia, MDPrincipal InvestigatorNYU Langone Health

Media Library

Cannabidiol (CBD) (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05020028 — Phase 2 & 3
Knee Arthritis Research Study Groups: CBD Group, Placebo Group
Knee Arthritis Clinical Trial 2023: Cannabidiol (CBD) Highlights & Side Effects. Trial Name: NCT05020028 — Phase 2 & 3
Cannabidiol (CBD) (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05020028 — Phase 2 & 3
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?
Met criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

I want to find a cure!
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. NYU Langone Health: < 48 hours
Average response time
  • < 2 Days
~26 spots leftby Jun 2024