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CBD for Knee Osteoarthritis Pain

This study is looking at whether cannabidiol (CBD) orally dissolving tablets (ODTs) can help reduce pain, improve how well your knee works, and increase your satisfaction if you have knee osteoarthritis. CBD comes from the cannabis plant but doesn't cause a 'high.' You might be able to join if you are between 40 and 75 years old, have knee osteoarthritis (KL Grade II-III), and have had knee pain for at least three months that is rated as 4 or higher on a pain scale. The study will measure success by looking at changes in your pain levels over time. The current status of this study is unclear, so it's not known if they are actively enrolling participants.

Study design
This is a multi-center, double-blinded, randomized, placebo-controlled study involving 100 participants. It compares CBD tablets to a placebo (a pill with no active ingredients) for knee pain.
What's involved
You would take 50mg of CBD or a placebo three times daily for 84 days. Your pain levels will be rated on days 1, 2, 7, 14, 28, 42, and 84.
Compensation
Not stated in the trial record.
Follow-up
Your pain, satisfaction, and clinical outcomes will be measured up to day 84 of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05020028

Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis

Recruiting
PHASE2Ages 40–75InterventionalTreatment
NYU Langone Health
~100 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Cannabidiol (CBD)Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
VAS Pain Severity Score
Measured over Day 1
+6 more outcomes measured

Conditions

Knee Arthritis

Explore related trials

Osteoarthritis

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Michael J Alaia, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Michael J Alaia, MD
[email protected]
646-501-7223
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Patients presenting with knee osteoarthritis (KL Grade II-III)
Knee pain for at least three months, occurring in at least half of the days in that period
VAS ≥ 4
Patients ages 40-75, inclusive
If female patients are pre-menopausal they must be currently practicing effective forms of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (less than 1% per year) when used consistently and correctly
Male patients must be using an effective form of contraception

Exclusion

Knee Injections within the last 3 months (cortisone, PRP, hyaluronic acid)
Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
Younger than 40 years of age
Older than 75 years of age
Any patient considered a vulnerable subject: pregnant women or fetuses, children, cognitively impaired adults, prisoners
History of cannabis abuse or dependence
History of coagulation abnormalities and thromboembolic disease or current abnormal coagulation test values
History of stroke or acute coronary syndromes within 3 months
Abnormal coagulation profile
Renal failure (serum creatinine \> 250 μmol/L \[2.83 mg/dL\]) or liver cirrhosis
Patients that have been on opioid management for any reason just prior to the study
Patients with known inflammatory arthritis (such as rheumatoid arthritis, gout, pseudogout etc)
Patients with a large effusion
Patients with a BMI \> 35
Patients meeting the DSM-V for major psychiatric illness, such as bipolar disorder
Patients diagnosed with major depression, psychosis, or substance abuse disorder
Patients with current or a history of suicidal ideation
Breastfeeding females
Abnormal LFTs
Patients with major neurological disorders, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain/head injury, or seizures
Patients with moderate (Child-Pugh B) and severe hepatic impairment (Child-Pugh C).
Patients taking moderate or strong inhibitors of CYP3A4 and CYP2C19 (listed below) concomitantly will be considered for exclusion if determined to be clinically significant by the treating physicians
Patients taking strong CYP3A4 and CYP2C19 inducers (listed below) concomitantly will be considered for exclusion if determined to be clinically significant by the treating physicians
Patients taking substrates of UTG1A9, UTGB17, CYP2A1, CYP2B6, CYP2C8, CYP2C9 and CYP2C19 (listed below) concomitantly will be considered for exclusion if determined to be clinically significant by the treating physicians

What this trial measures

  • VAS Pain Severity ScoreDay 1

    A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.

  • VAS Pain Severity ScoreDay 2

    A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.

  • VAS Pain Severity ScoreDay 7

    A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.

  • VAS Pain Severity ScoreDay 14

    A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.

  • VAS Pain Severity ScoreDay 28

    A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.

  • VAS Pain Severity ScoreDay 42

    A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.

  • VAS Pain Severity ScoreDay 84

    A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.