Recruiting
Phase 1
Phase 2

CBD

Sponsor:

University of Florida

Code:

NCT06414473

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Cannabidiol (CBD) Extract

Placebo

Study Details

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

Study ID

NCT06414473

Start date

Jun 14, 2024

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

placebo comparator: Vehicle Control

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

Interventions

Cannabidiol (CBD) Extract

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

Placebo

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

Primary outcome measure

  • Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [ Time Frame: Weekly until 1 month ]
  • Theoretical Framework of Acceptability Questionnaire (TFAQ) [ Time Frame: Baseline and 1 month ]
  • Self-report Ratings of Knee Pain [ Time Frame: Baseline and 1 month, daily until 1 month ]
  • Physical Activity [ Time Frame: Daily until 1 month ]
  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: Baseline and 1 month ]

Central Contacts and Locations

Central contacts

Locations

Sports Medicine Research Laboratory

Recruiting

Gainesville, Florida, United States, 32601

Contacts

More Information

Sponsor

University of Florida

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Keywords

  • Cannabidiol
  • Osteoarthritis
  • Pain
  • Dysfunction
  • Physical Activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2025-09-17.