CBD for Knee Osteoarthritis

NCT06414473 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB202301136
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Cannabidiol; Osteoarthritis; Pain; Dysfunction; Physical Activity

Outcome Measures

Primary Outcomes (5)

• Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Categorical scale, None or not at all (0) and very severe or very much (4), higher scores mean worse outcome

  Weekly until 1 month

• Theoretical Framework of Acceptability Questionnaire (TFAQ)

  Likert scale, 1 and 5, higher scores mean worse outcome

  Baseline and 1 month

• Self-report Ratings of Knee Pain

  Numeric Rating Scale, 0 and 10, higher scores mean worse outcome

  Baseline and 1 month, daily until 1 month

• Physical Activity

  Accelerometer measures step counts per day

  Daily until 1 month

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  Categorical scale, none (0) and extreme (4), higher scores mean worse outcome

  Baseline and 1 month

Secondary Outcomes (6)

• Quantitative Sensory Testing (QST)

  Baseline and 1 month

• Physical Function

  Baseline and 1 month

• Fear of Pain Questionnaire III (FPQ III)

  Baseline and 1 month

• Pain Catastrophizing Scale (PCS)

  Baseline and 1 month

• Pain Anxiety Symptom Scale (PASS-20)

  Baseline and 1 month

Study Arms (2)

Active Drug

ACTIVE COMPARATOR

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.

Drug: Cannabidiol (CBD) Extract

Vehicle Control

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Cannabidiol (CBD) Extract DRUG

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

Also known as: Hemp Supplement

Active Drug

Placebo DRUG

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

Also known as: Vehicle Control

Vehicle Control

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• established clinical diagnosis of knee osteoarthritis (KOA)
• moderate to severe knee pain (≥4/10) with physical activity in one or both knees

You may not qualify if:

• pregnant (urine pregnancy test) or lactating
• current cannabis (THC and/or CBD) use (urine drug screen)
• any prior or ongoing medical condition that, in the investigators' opinion, could adversely affect the safety of the subject
• 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
• any exposure to another investigational drug within 3 months prior to screening
• BMI ≥ 45
• current use of any enzyme-modifying drugs, including strong inhibitors or strong inducers of cytochrome P (CYP) enzymes
• history of:
• suicidal ideation or self-harm behavior
• seizure disorder or traumatic brain injury,
• liver or kidney disease, and
• cardiovascular diseases

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Sports Medicine Research Laboratory

Gainesville, Florida, 32601, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain; Motor Activity

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Paul A. Borsa, PhD

CONTACT

352-294-1726; pborsa@ufl.edu

John W Stauffer, MS

CONTACT

352-294-1777; johnstauffer@ufl.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants, investigators, and study personnel will be blinded to treatment order assignments throughout the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, clinical trial

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 16, 2024
• Study Start: June 14, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (1)