CBD for Osteoarthritis
(SLACK-OA Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using cannabis or certain enzyme-modifying drugs. It's best to discuss your specific medications with the trial team.
Is CBD safe for human use?
CBD, including products like Epidiolex, is generally considered safe for human use, but it can cause side effects such as sleep disturbances, sedation, and liver enzyme changes. It may also interact with other medications, so it's important to discuss its use with a healthcare provider, especially if you are taking other drugs.12345
How is the drug CBD unique for treating osteoarthritis?
CBD (Cannabidiol) is unique for treating osteoarthritis because it is derived from cannabis and is known for its anti-inflammatory properties, which may help reduce joint pain and inflammation. Unlike some traditional treatments, CBD is often used in a more natural form and may offer an alternative for those seeking non-opioid pain relief options.678910
What is the purpose of this trial?
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
This trial is for adults with knee osteoarthritis experiencing moderate to severe pain (at least 4 out of 10) during physical activity. It's aimed at those who seek an alternative to NSAIDs for managing their pain.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Testing
Participants undergo baseline testing before the dosing regimen begins
Treatment
Participants receive a 30-day dosing regimen of either CBD or placebo
Wash-out
A 2-week wash-out period before the cross-over phase
Cross-over Treatment
Participants switch to the alternate treatment (CBD or placebo) for another 30-day dosing regimen
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cannabidiol (CBD) Extract
Cannabidiol (CBD) Extract is already approved in United States, European Union, Canada for the following indications:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Symptomatic relief of spasticity in adult patients with multiple sclerosis
- Adjunctive treatment for the symptomatic relief of neuropathic pain in adult patients with multiple sclerosis
- Adjunctive analgesic treatment for moderate to severe pain in adult patients with advanced cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor