CBD for Knee Osteoarthritis

NCT ID: NCT06414473

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-14
• Study Completion Date: 2026-12-31

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, tolerability/acceptability, 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 (≥4/10) 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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active Drug

Hemp supplement is a full spectrum CBD-rich formulation (\~10%) containing very low levels of THC (\<0.3%), along with all naturally occurring minor cannabinoids, terpenes, and essential oils from the plant extract.

Group Type: ACTIVE_COMPARATOR

Cannabidiol (CBD) Extract

Intervention Type: DRUG

Administered thrice daily (with food) using a sublingual route of administration

Vehicle Control

A medium chain triglyceride-based mixing agent blended with coconut oil will be used as the placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered thrice daily (with food) using a sublingual route of administration

Interventions

Cannabidiol (CBD) Extract

Administered thrice daily (with food) using a sublingual route of administration

Intervention Type: DRUG

Placebo

Administered thrice daily (with food) using a sublingual route of administration

Intervention Type: DRUG

Other Intervention Names

Hemp Supplement; Vehicle Control

Eligibility Criteria

Inclusion Criteria

1. established clinical diagnosis of knee osteoarthritis (KOA)

2. moderate to severe knee pain (≥4/10) with physical activity in one or both knees

Exclusion Criteria

1. pregnant (urine pregnancy test) or lactating

2. current cannabis (THC and/or CBD) use (urine drug screen)

3. any prior or ongoing medical condition that, in the investigators' opinion, could adversely affect the safety of the subject

4. any major surgery within 3 months prior to recruitment or planned orthopedic surgery for any time during this study which would interfere with the ability to report pain or quality of life outcome measures

5. any exposure to another investigational drug within 3 months prior to screening

6. BMI ≥ 45

7. current use of any enzyme-modifying drugs, including strong inhibitors or strong inducers of cytochrome P (CYP) enzymes

8. history of:

1. suicidal ideation or self-harm behavior

2. seizure disorder or traumatic brain injury,

3. liver or kidney disease, and

4. cardiovascular diseases

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sports Medicine Research Laboratory

Gainesville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Paul A. Borsa, PhD

Role: CONTACT

pborsa@ufl.edu

352-294-1726

John W Stauffer, MS

Role: CONTACT

johnstauffer@ufl.edu

352-294-1777

Facility Contacts

Paul A Borsa, PhD

Role: primary

pborsa@ufl.edu

352-294-1726

John W Stauffer, MS

Role: backup

john.Stauffer@ufl.edu

352-294-1777

Other Identifiers

IRB202301136

Identifier Type: -

Identifier Source: org_study_id