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The Use of Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis. A Double-Blind, Randomized Control Study

Who is this study for? Patients with knee osteoarthritis
What treatments are being studied? Cannabidiol
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

The purpose of this study is to see if cannabidiol (CBD) orally dissolving tablets (ODTs) can lessen pain, improve function, and improve patient satisfaction in cases of knee osteoarthritis. CBD comes from the cannabis plant and is non-psychoactive (i.e. does not produce a 'high' or altered mental state) as compared to tetrahydrocannabinol (THC), another compound found in cannabis. Researchers are studying different forms of CBD for potential use in treating pain, inflammation, and illnesses.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

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

• Knee pain for at least three months, occurring in at least half of the days in that period

• VAS ≥ 4

• Patients ages 40-75, inclusive

• If female patients are pre-menopausal they must be currently practicing effective forms of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (less than 1% per year) when used consistently and correctly

• Male patients must be using an effective form of contraception

Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Michael J Alaia, MD
michael.alaia@nyulangone.org
646-501-7223
Backup
Emma Trasatti
emma.trasatti@nyulangone.org
Time Frame
Start Date: 2022-06-22
Estimated Completion Date: 2026-09
Participants
Target number of participants: 100
Treatments
Experimental: CBD Group
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.
Placebo_comparator: Placebo Group
Cohort 2 will receive the same instructions, but with the placebo Orally Disintegrating Tablets (ODT) instead.
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health
Collaborators: Orcosa Inc.

This content was sourced from clinicaltrials.gov