CBD for Knee Osteoarthritis

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06414473
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Osteoarthritis, Knee

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Cannabidiol (CBD) Extract — DRUG
    Administered thrice daily (with food) using a sublingual route of administration
  • Placebo — DRUG
    Administered thrice daily (with food) using a sublingual route of administration

Study Details

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.

Key Dates

Start date
Jun 14, 2024
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [ Time Frame: Weekly until 1 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sports Medicine Research LaboratoryGainesvilleFlorida32601
Paul A Borsa, PhD
[email protected]
352-294-1726
John W Stauffer, MS
[email protected]
352-294-1777

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Sports Medicine Research Laboratory· Gainesville, FL

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