Clinical trial NCT05020028: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Knee Arthritis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Orcosa Inc.
First posted: 2021-08-25
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: VAS Pain Severity Score
timeFrame: Day 1
measure: VAS Pain Severity Score
timeFrame: Day 2
measure: VAS Pain Severity Score
timeFrame: Day 7
measure: VAS Pain Severity Score
timeFrame: Day 14
measure: VAS Pain Severity Score
timeFrame: Day 28
measure: VAS Pain Severity Score
timeFrame: Day 42
measure: VAS Pain Severity Score
timeFrame: Day 84
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Week 6
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Week 12
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Week 60
measure: VAS Satisfaction with Pain Management Score
timeFrame: Day 1
measure: VAS Satisfaction with Pain Management Score
timeFrame: Day 2
measure: VAS Satisfaction with Pain Management Score
timeFrame: Day 7
measure: VAS Satisfaction with Pain Management Score
timeFrame: Day 14
measure: VAS Satisfaction with Pain Management Score
timeFrame: Day 28
measure: VAS Satisfaction with Pain Management Score
timeFrame: Day 42
measure: VAS Satisfaction with Pain Management Score
timeFrame: Day 84
measure: Number of Patients Requiring Rescue Corticosteroid Use
timeFrame: Up to Week 60
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Michael J Alaia, MD
role: PRINCIPAL_INVESTIGATOR
References: