The Use of Cannabinoid Patch for Knee Osteoarthritis

• Status: Not yet recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, double-blind 2-arm parallel group study to determine the efficacy of a cannabinoid (CBD) patch on reducing pain in patients with knee osteoarthritis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Collaborator: Solace Brands, Inc.

Criteria

Inclusion Criteria:

1. Age>18 years old

2. Osteoarthritis diagnosed radiographically as Kellgren Lawrence classification 2-4

3. Visual analogue scale greater than 3 but less than 9

4. Subject is able to provide written informed consent prior to any study procedures or interventions.

5. Ability, in the opinion of the investigator, to understand the nature of the study and comply with protocol requirements including compliance with scheduled visits, treatment plan, and any other study procedures outlined in this protocol.

6. Able to wear a patch for 24 hours a day

7. Able to participate in physical therapy

Exclusion Criteria:

1. Subject presents with a visual analogue scale score less than 4 or greater than 8.

2. Subject is Pregnant.

3. Patient has known recent substance abuse or dependence on alcohol (regularly consumes 3 or more alcoholic drinks per day), narcotic analgesics, tranquilizers, or opioids; in the judgement of the investigator within the past 3 years.

4. Subject has had prior surgery to the studied lower extremity within 6 months.

5. Subject has a known history of allergy to CBD or its derivatives

6. Subject has a known history of allergic, idiosyncratic, or serious adverse reactions to acetaminophen.

7. Patient had recent steroid injection to the studied knee within the last 3 months

8. Subject has an inability to be available for follow up

9. Any patients with prior liver pathology including, cirrhosis, hepatitis, Hepatic Carcinoma, or elevated liver function tests will be excluded from the study group. Patients with elevated baseline transaminase levels above 3 times the upper limit of normal, accompanied by elevations in bilirubin above 2 times the upper limits of normal.

10. Subjects with a medical disorder, condition or history such that could impair the subject's ability to participate or complete this study in the opinion of the investigator.

11. Patient has chronic opioid dependency (taking opioid's >3months), currently taking selective serotonin reuptake inhibitor or benzodiazepines.

12. Patient currently using CBD product and not willing to discontinue use 1 week prior to enrollment.