What is the mechanism of action of this treatment?

Common treatments for knee arthritis, such as NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) and CBD (Cannabidiol), primarily work by reducing inflammation and alleviating pain. NSAIDs inhibit cyclooxygenase enzymes (COX-1 and COX-2), which play a key role in the inflammatory process, thereby decreasing swelling and pain. CBD, a non-psychoactive compound from the cannabis plant, interacts with the endocannabinoid system to modulate pain and inflammation. These mechanisms are crucial for knee arthritis patients as they help manage chronic pain and improve joint function, enhancing overall quality of life.

What side effects are associated with this type of intervention?

Common treatments for knee arthritis, such as NSAIDs, corticosteroids, and CBD, have various side effects. NSAIDs can cause gastrointestinal issues, cardiovascular problems, and kidney damage. Corticosteroids may lead to weight gain, osteoporosis, and increased infection risk. CBD, which is being studied for its anti-inflammatory and analgesic properties, is generally well-tolerated but can cause dry mouth, diarrhea, and fatigue.

What prior FDA approvals exist?

The FDA has approved several treatments for knee arthritis that possess anti-inflammatory and analgesic properties. Commonly prescribed medications include nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen, which help reduce inflammation and pain. Additionally, corticosteroid injections are used to provide relief from severe pain and inflammation. While Cannabidiol (CBD) is being studied for its potential benefits in pain and inflammation management, it is not yet FDA-approved specifically for knee arthritis. Other treatments like hyaluronic acid injections and physical therapy are also commonly recommended to manage symptoms.

What other types of research exist?

Promising alternatives to CBD Orally Dissolving Tablets for knee arthritis include: 1) Infliximab, which has shown superior efficacy in improving knee pain compared to other biologic agents; 2) Tofacitinib, recommended for patients with moderate to high activity RA after failure of other treatments; 3) Emerging therapies like ketamine and lidocaine infusions, which have shown mixed results but potential benefits for chronic pain management.

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Cannabinoid

CBD for Knee Osteoarthritis

Phase 2 & 3

Recruiting

Led By Michael J Alaia, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients presenting with knee osteoarthritis (KL Grade II-III)

Male patients must be using an effective form of contraception

Must not have

Renal failure (serum creatinine > 250 μmol/L [2.83 mg/dL]) or liver cirrhosis

Breastfeeding females

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 84

Summary

This trial is testing if CBD tablets that dissolve in the mouth can reduce pain and improve function in people with knee osteoarthritis. The study targets patients who are already doing physiotherapy and home exercises. CBD is thought to work by interacting with the body's system that controls pain and inflammation. CBD is a non-euphoric component of cannabis that has shown potential in relieving pain and reducing inflammation in osteoarthritis.

Who is the study for?

Adults aged 40-75 with knee osteoarthritis (KL Grade II-III) and pain for at least three months can join. They must have a VAS score of ≥4, indicating moderate to severe pain, and use effective contraception if applicable. Excluded are those with mental impairments, extreme obesity (BMI > 35), liver or kidney issues, certain drug interactions, history of substance abuse or major psychiatric disorders.

What is being tested?

The trial is testing whether CBD orally dissolving tablets can reduce pain and improve function in knee osteoarthritis patients compared to a placebo. Participants will not experience any 'high' as the treatment does not contain THC.

What are the potential side effects?

Potential side effects of CBD may include tiredness, changes in appetite or weight, diarrhea, and sometimes mood changes like irritability or agitation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have moderate knee arthritis.

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I am a male and I use effective birth control methods.

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I am using two effective birth control methods as a pre-menopausal woman.

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I am between 40 and 75 years old.

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I have had knee pain for at least 3 months, on most days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe kidney or liver problems.

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I am currently breastfeeding.

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I do not have major neurological disorders like dementia or epilepsy.

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My liver function is moderately or severely impaired.

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I am currently taking medications that affect liver enzyme activity.

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I have not had a stroke or heart attack in the last 3 months.

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I haven't had knee injections (cortisone, PRP, hyaluronic acid) in the last 3 months.

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I am legally competent and mentally sound.

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I have a diagnosed inflammatory arthritis condition.

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I am over 75 years old.

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I am under 40 years old.

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I have a large buildup of fluid in my body.

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I am currently taking medications that strongly affect my liver enzymes.

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I am not taking strong CYP3A4 or CYP2C19 inducers together.

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I have thought about or have a history of thinking about suicide.

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I have a history of blood clotting issues or abnormal coagulation test results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 84

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 84

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 84 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain

Secondary study objectives

Knee

Pain

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CBD GroupExperimental Treatment1 Intervention

The first cohort will take two 25mg cannabidiol (total dose: 50mg) Orally Disintegrating Tablets (CBD ODT) three times daily for a maximum dose of 150mg per day.

Group II: Placebo GroupPlacebo Group1 Intervention

Cohort 2 will receive the same instructions, but with the placebo Orally Disintegrating Tablets (ODT) instead.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cannabidiol (CBD)

2021

Completed Phase 2

~140

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for knee arthritis, such as NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) and CBD (Cannabidiol), primarily work by reducing inflammation and alleviating pain. NSAIDs inhibit cyclooxygenase enzymes (COX-1 and COX-2), which play a key role in the inflammatory process, thereby decreasing swelling and pain. CBD, a non-psychoactive compound from the cannabis plant, interacts with the endocannabinoid system to modulate pain and inflammation. These mechanisms are crucial for knee arthritis patients as they help manage chronic pain and improve joint function, enhancing overall quality of life.