Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 6:12 PM
Study NCT ID:
NCT05020028
Status:
RECRUITING
Last Update Posted:
2025-08-01
First Post:
2021-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
The Use of Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis. A Double-Blind, Randomized Control Study
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: