Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis

Official title

The Use of Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis. A Double-Blind, Randomized Control Study

Overview

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.

Detailed description

This will be a multi-center, double-blinded, randomized, placebo-controlled study. The study is comparing pain, outcomes, and patient satisfaction in two cohorts: patients with knee OA undergoing physiotherapy/home exercises who receive CBD and a placebo group with PT/home exercise program. Patients will be asked on treatment Day 1, 2, 7, and 14, 28, 42, and 84 to rate their pain according to the VAS scale. Additionally, patient satisfaction and clinical outcomes will be measured.

Interventions

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

Primary outcome measures

• 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]

Secondary outcome measures (12)

• Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: Baseline]
• Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: Week 6]
• Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: Week 12]
• Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: Week 60]
• VAS Satisfaction with Pain Management Score [Time frame: Day 1]
• VAS Satisfaction with Pain Management Score [Time frame: Day 2]
• VAS Satisfaction with Pain Management Score [Time frame: Day 7]
• VAS Satisfaction with Pain Management Score [Time frame: Day 14]
• VAS Satisfaction with Pain Management Score [Time frame: Day 28]
• VAS Satisfaction with Pain Management Score [Time frame: Day 42]
• VAS Satisfaction with Pain Management Score [Time frame: Day 84]
• Number of Patients Requiring Rescue Corticosteroid Use [Time frame: Up to Week 60]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• NYU Langone Health — New York

Identifiers

NCT: NCT05020028 · 21-00334

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗