Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414473
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-24
Brief Title:
CBD for Knee Osteoarthritis
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Sub-Lingual Administration of Cannabidiol for Knee Osteoarthritis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLACK-OA
Brief Summary:
Osteoarthritis is a disease that affects millions of Americans and is the leading cause of persistent pain and physical disability in the older adult population Many physically active Americans have reported pain-relieving effects of cannabidiol CBD that can reduce or eliminate use of nonsteroidal anti-inflammatory drugs NSAIDs for activity-related pain with minimal to no side effects Long-term use of over-the-counter medications including NSAIDs can pose a significant health risk and therefore clinical research on the safety and efficacy of CBD is needed
Detailed Description:
Knee OA is the most common joint disease and a major cause of functional limitation and pain in adults Pain is the primary symptom of OA and the main reason people seek medical treatment Although pharmacologic treatment for OA such as opioid-based medications may help in the short-term with reducing pain-related symptoms they are known to have mild to severe side effects along with the potential for long-term dependency Consequently many Americans have turned to cannabis-related products like cannabidiol or CBD for reducing pain and pain-related symptoms associated with OA Current research has shown evidence that phyto-cannabinoids may have a promising therapeutic potential in a variety of physical and psychological ailments and cannabidiol CBD is of particular interest due to its positive safety profile non-intoxicating effects and purported therapeutic capabilities in several musculoskeletal diseases In vitro and in vivo studies have shown that CBD administration in the short term is safe and effective in reducing inflammation and pain behaviors in animal models of OA Despite the widespread popularity of CBD in the US there is very limited data that indicates the safety acceptability and pain-relieving effects of CBD use for people with symptomatic knee osteoarthritis The investigators objective will be to conduct an early-stage clinical trial to investigate the safety tolerabilityacceptability and efficacy of CBD as a non-pharmacological treatment for symptomatic knee OA The investigators will conduct an innovative and novel study with rigorous scientific design that will assess and monitor symptomatic relief and improved function following CBD administration active or placebo-control using a randomized double-blind placebo-controlled cross-over study design The investigators will be recruiting 30 adult men and women between 40 and 75 years of age with an established clinical diagnosis of knee OA To be included in the study participants must report having moderate to severe knee pain 410 with physical activity in one or both knees Subjects will be required to complete a 78-day study trial spanning a pre-dosing screening visit baseline testing 30-day dosing regimen with follow-up testing A 2-week wash-out period will be followed by the cross-over phase using identical baseline and follow-up testing procedures The data from the active CBD phase will be compared to data from the placebo-control phase There is an extremely large consumer base for CBD-related products in the US and this base will be expanding exponentially over the course of this decade therefore scientific investigation into its therapeutic potential is necessary
Study Oversight
Has Oversight DMC:
None
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?:
None