30 Participants Needed

CBD for Osteoarthritis

(SLACK-OA Trial)

JW
PA
Overseen ByPaul A. Borsa, PhD
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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

I have been diagnosed with knee osteoarthritis.
I experience knee pain of 4 or more out of 10 when active.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Testing

Participants undergo baseline testing before the dosing regimen begins

1 week
1 visit (in-person)

Treatment

Participants receive a 30-day dosing regimen of either CBD or placebo

4 weeks
Weekly visits (virtual)

Wash-out

A 2-week wash-out period before the cross-over phase

2 weeks

Cross-over Treatment

Participants switch to the alternate treatment (CBD or placebo) for another 30-day dosing regimen

4 weeks
Weekly visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

Treatment Details

Interventions

  • Cannabidiol (CBD) Extract
Trial Overview The study tests the safety and effectiveness of Cannabidiol (CBD) extract in reducing knee pain caused by osteoarthritis, compared to a placebo. Participants will not know if they are receiving CBD or the placebo.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Active DrugActive Control1 Intervention
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.
Group II: Vehicle ControlPlacebo Group1 Intervention
A medium chain triglyceride-based mixing agent blended with coconut oil will be used as the placebo.

Cannabidiol (CBD) Extract is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Epidiolex for:
  • Seizures associated with Lennox-Gastaut syndrome
  • Seizures associated with Dravet syndrome
  • Seizures associated with tuberous sclerosis complex
🇪🇺
Approved in European Union as Epidyolex for:
  • Seizures associated with Lennox-Gastaut syndrome
  • Seizures associated with Dravet syndrome
  • Seizures associated with tuberous sclerosis complex
🇨🇦
Approved in Canada as Sativex for:
  • 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

Trials
1,428
Recruited
987,000+

Findings from Research

A single oral dose of 750 mg of cannabidiol (CBD) showed significantly increased exposure when taken with a high-fat/calorie meal, with a 3.8-fold increase in overall exposure (AUC0-∞) and a 5.2-fold increase in maximum concentration (Cmax) compared to fasting.
CBD was well-tolerated with no severe adverse events reported, indicating its safety in healthy adults, while its absorption was also enhanced by low-fat meals, whole milk, and alcohol, albeit to a lesser extent.
A phase 1, randomized, pharmacokinetic trial of the effect of different meal compositions, whole milk, and alcohol on cannabidiol exposure and safety in healthy subjects.Crockett, J., Critchley, D., Tayo, B., et al.[2021]
Epidiolex, the only FDA-approved CBD-based drug, has been studied for its medicinal benefits and potential side effects across various clinical trials, focusing on both physiological and neurological conditions.
The review highlights that the outcomes of these trials can vary significantly based on the funding source, which may influence the reported efficacy and safety of Epidiolex and other CBD formulations.
Cannabidiol Drugs Clinical Trial Outcomes and Adverse Effects.Pauli, CS., Conroy, M., Vanden Heuvel, BD., et al.[2020]
Cannabidiol (CBD) is a non-psychoactive compound from cannabis that can counteract the psychotropic effects of THC and has gained popularity in various therapeutic products, especially after the FDA approved Epidiolex® for treating severe epilepsy in children.
Despite its therapeutic potential, there is a lack of consistent international regulations governing the marketing and authorization of CBD products, which raises concerns about product safety and efficacy for consumers.
Pharmacology and legal status of cannabidiol.Brunetti, P., Lo Faro, AF., Pirani, F., et al.[2021]

References

A phase 1, randomized, pharmacokinetic trial of the effect of different meal compositions, whole milk, and alcohol on cannabidiol exposure and safety in healthy subjects. [2021]
Cannabidiol Drugs Clinical Trial Outcomes and Adverse Effects. [2020]
Pharmacology and legal status of cannabidiol. [2021]
Long-term efficacy and safety of cannabidiol (CBD) in children with treatment-resistant epilepsy: Results from a state-based expanded access program. [2021]
Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. [2020]
Cartilage protective and anti-analgesic effects of ALM16 on monosodium iodoacetate induced osteoarthritis in rats. [2020]
Effectiveness of topical ozonated oil in severe osteoarthritis: A randomised, triple-blinded, placebo-controlled study. [2021]
Isovitexin Depresses Osteoarthritis Progression via the Nrf2/NF-κB Pathway: An in vitro Study. [2022]
[Effectiveness and tolerance of standardized willow bark extract in arthrosis patients. Randomized, placebo controlled double-blind study]. [2019]
Extracts of Oldenlandia diffusa protects chondrocytes via inhibiting apoptosis and associated inflammatory response in osteoarthritis. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security