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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 belowSelect...
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:Select...
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
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
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.
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,409 Previous Clinical Trials
855,488 Total Patients Enrolled
Orcosa Inc.UNKNOWN
1 Previous Clinical Trials
100 Total Patients Enrolled
Michael J Alaia, MDPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe kidney or liver problems.I am currently breastfeeding.I do not have major neurological disorders like dementia or epilepsy.I have moderate knee arthritis.My liver function is moderately or severely impaired.I am currently taking medications that affect liver enzyme activity.I have not had a stroke or heart attack in the last 3 months.I am a male and I use effective birth control methods.I am using two effective birth control methods as a pre-menopausal woman.I am between 40 and 75 years old.I haven't had knee injections (cortisone, PRP, hyaluronic acid) in the last 3 months.I am legally competent and mentally sound.I have a diagnosed inflammatory arthritis condition.I am over 75 years old.I am under 40 years old.I have a large buildup of fluid in my body.I am currently taking medications that strongly affect my liver enzymes.I am not taking strong CYP3A4 or CYP2C19 inducers together.I have thought about or have a history of thinking about suicide.I have a history of blood clotting issues or abnormal coagulation test results.I have had knee pain for at least 3 months, on most days.I am using two effective birth control methods if I am pre-menopausal.
Research Study Groups:
This trial has the following groups:- Group 1: CBD Group
- Group 2: Placebo Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Knee Arthritis Patient Testimony for trial: Trial Name: NCT05020028 — Phase 2 & 3
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