Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis

NCT05020028 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 21-00334
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• VAS Pain Severity Score

  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.

  Day 1

• VAS Pain Severity Score

  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.

  Day 2

• VAS Pain Severity Score

  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.

  Day 7

• VAS Pain Severity Score

  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.

  Day 14

• VAS Pain Severity Score

  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.

  Day 28

• VAS Pain Severity Score

  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.

  Day 42

• VAS Pain Severity Score

  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.

  Day 84

Secondary Outcomes (12)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Baseline

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Week 6

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Week 12

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Week 60

• VAS Satisfaction with Pain Management Score

  Day 1

Study Arms (2)

CBD Group

EXPERIMENTAL

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.

Drug: Cannabidiol (CBD)

Placebo Group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Cannabidiol (CBD) DRUG

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.

Also known as: Cannabidiol

CBD Group

Placebo DRUG

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

Placebo Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Orcosa Inc.: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Michael J Alaia, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael J Alaia, MD

CONTACT

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

Emma Trasatti

CONTACT

emma.trasatti@nyulangone.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 25, 2021
• Study Start: June 22, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)