NCT06414473 CBD for Knee Osteoarthritis
| NCT ID | NCT06414473 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Florida |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-06-14 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2024-06-14 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06414473 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06414473 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06414473 currently recruiting?
Yes, NCT06414473 is actively recruiting participants. Contact the research team at pborsa@ufl.edu for enrollment information.
Where is the NCT06414473 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT06414473 clinical trial?
NCT06414473 is sponsored by University of Florida. The trial plans to enroll 30 participants.