RECRUITING

Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-06-22

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05020028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Michael J Alaia, MD

CONTACT

646-501-7223

michael.alaia@nyulangone.org

Isabel Chalem

CONTACT

isabel.chalem@nyulangone.org

Principal Investigator

Michael J Alaia, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

NYU Langone Health

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Michael J Alaia, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-22

Study Completion Date2025-09

Study Record Updates

Study Start Date2022-06-22

Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

Knee Arthritis