Recruiting
Phase 2
Phase 3

Cannabidiol

Sponsor:

NYU Langone Health

Code:

NCT05020028

Conditions

Knee Arthritis

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Cannabidiol (CBD)

Placebo

Study Details

Brief summary:

The purpose of this study is to see if cannabidiol (CBD) orally dissolving tablets (ODTs) can lessen pain, improve function, and improve patient satisfaction in cases of knee osteoarthritis. CBD comes from the cannabis plant and is non-psychoactive (i.e. does not produce a 'high' or altered mental state) as compared to tetrahydrocannabinol (THC), another compound found in cannabis. Researchers are studying different forms of CBD for potential use in treating pain, inflammation, and illnesses.

Conditions

Knee Arthritis

Study ID

NCT05020028

Start date

Jun 22, 2022

Status verified date

Jun, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBD Group

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.

placebo comparator: Placebo Group

Cohort 2 will receive the same instructions, but with the placebo Orally Disintegrating Tablets (ODT) instead.

Interventions

Cannabidiol (CBD)

Patients will be dispensed enough 25mg cannabidiol (CBD) Orally Disintegrating Tablets (ODT) to take a standard dose of 50mg three times daily for 84 days.

Placebo

25mg Placebo ODT looks like the cannabidiol (CBD) Orally Disintegrating Tablets (ODT), but contains no active ingredients.

Primary outcome measure

  • VAS Pain Severity Score [ Time Frame: Day 1 ]
  • VAS Pain Severity Score [ Time Frame: Day 2 ]
  • VAS Pain Severity Score [ Time Frame: Day 7 ]
  • VAS Pain Severity Score [ Time Frame: Day 14 ]
  • VAS Pain Severity Score [ Time Frame: Day 28 ]
  • VAS Pain Severity Score [ Time Frame: Day 42 ]
  • VAS Pain Severity Score [ Time Frame: Day 84 ]

Central Contacts and Locations

Central contacts

Michael J Alaia, MD

646-501-7223michael.alaia@nyulangone.org

Layne Estes

Layne.estes@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Michael Alaia, MD

More Information

Sponsor

NYU Langone Health

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-06-09.