Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 40 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.
    Other names:
    • Cannabidiol
Placebo Comparator
Placebo Group 		Cohort 2 will receive the same instructions, but with the placebo Orally Disintegrating Tablets (ODT) instead.
  • Drug: Placebo
    25mg Placebo ODT looks like the cannabidiol (CBD) Orally Disintegrating Tablets (ODT), but contains no active ingredients.

Recruiting Locations

NYU Langone Health
New York, New York 10016

More Details

Status
Recruiting
Sponsor
NYU Langone Health

Study Contact

Michael J Alaia, MD
646-501-7223
michael.alaia@nyulangone.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.