The Use of Cannabinoid Patch for Knee Osteoarthritis

NCT04412837 | Withdrawn Phase 2

• 1 other identifier: 20-0048
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis; CBD; Osteoarthritis

Keywords

Cannabidiol

Outcome Measures

Primary Outcomes (1)

• Influence of CBD patch on pain for patients with knee osteoarthritis using Visual Analogue Scale.

  Efficacy of 35mg CBD Patch vs Placebo Patch on treatment of pain for patients with knee osteoarthritis assessed by a visual analogue scale using 0 as no pain and 10 as the worst pain. This will be collect at weeks 1, 2, 3, 4, and 8, where pain control method (CBD vs Placebo) is the between subjects' effect and week of treatment is the within subjects effect will be used to examine the association between pain control method and that outcome.

  8 weeks.

Secondary Outcomes (5)

• Influence of CBD patch on physical and mental health for patients with knee osteoarthritis using the Short Form-12.

  8 weeks.

• Influence of CBD patch on quality of sleep for patients with knee osteoarthritis using the Pittsburgh Sleep Quality Index.

  8 weeks.

• Influence of CBD patch on physical function and emotional health for patients with knee osteoarthritis using the Brief Pain Inventory.

  8 weeks.

• Influence of CBD patch on knee function and pain for patients with knee osteoarthritis using the Knee Injury and Osteoarthritis Outcome Score.

  8 weeks.

• Safety Profile and Adverse Effects of CBD patch

  8 weeks.

Study Arms (2)

CBD Patch

EXPERIMENTAL

Topical CBD patch to be worn for 24 hours and changed daily for the course of 4 weeks.

Drug: Topical CBD Patch

Control Patch

PLACEBO COMPARATOR

Control placebo patch to be worn for 24 hours and changed daily for the course of 4 weeks.

Other: Placebo Patch

Interventions

Topical CBD Patch DRUG

35 mg CBD patch

CBD Patch

Placebo Patch OTHER

Identical patch without active ingredient.

Control Patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years old
• Osteoarthritis diagnosed radiographically as Kellgren Lawrence classification 2-4
• Visual analogue scale greater than 3 but less than 9
• Subject is able to provide written informed consent prior to any study procedures or interventions.
• 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.
• Able to wear a patch for 24 hours a day
• Able to participate in physical therapy

You may not qualify if:

• Subject presents with a visual analogue scale score less than 4 or greater than 8.
• Subject is Pregnant.
• 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.
• Subject has had prior surgery to the studied lower extremity within 6 months.
• Subject has a known history of allergy to CBD or its derivatives
• Subject has a known history of allergic, idiosyncratic, or serious adverse reactions to acetaminophen.
• Patient had recent steroid injection to the studied knee within the last 3 months
• Subject has an inability to be available for follow up
• 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.
• 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.
• Patient has chronic opioid dependency (taking opioid's \>3months), currently taking selective serotonin reuptake inhibitor or benzodiazepines.
• Patient currently using CBD product and not willing to discontinue use 1 week prior to enrollment.

Sponsors & Collaborators

• Northwell Health: lead
• Solace Brands, Inc.: collaborator

Study Sites (1)

Northwell Health Orthopedic Institute at Great Neck

New Hyde Park, New York, 11040, United States

Location

Related Publications (9)

• Baer PA, Thomas LM, Shainhouse Z. Treatment of osteoarthritis of the knee with a topical diclofenac solution: a randomised controlled, 6-week trial [ISRCTN53366886]. BMC Musculoskelet Disord. 2005 Aug 8;6:44. doi: 10.1186/1471-2474-6-44.

  PMID: 16086839 BACKGROUND

• Martin-Santos R, Crippa JA, Batalla A, Bhattacharyya S, Atakan Z, Borgwardt S, Allen P, Seal M, Langohr K, Farre M, Zuardi AW, McGuire PK. Acute effects of a single, oral dose of d9-tetrahydrocannabinol (THC) and cannabidiol (CBD) administration in healthy volunteers. Curr Pharm Des. 2012;18(32):4966-79. doi: 10.2174/138161212802884780.

  PMID: 22716148 BACKGROUND

• Haney M, Malcolm RJ, Babalonis S, Nuzzo PA, Cooper ZD, Bedi G, Gray KM, McRae-Clark A, Lofwall MR, Sparenborg S, Walsh SL. Oral Cannabidiol does not Alter the Subjective, Reinforcing or Cardiovascular Effects of Smoked Cannabis. Neuropsychopharmacology. 2016 Jul;41(8):1974-82. doi: 10.1038/npp.2015.367. Epub 2015 Dec 28.

  PMID: 26708108 BACKGROUND

• Babalonis S, Haney M, Malcolm RJ, Lofwall MR, Votaw VR, Sparenborg S, Walsh SL. Oral cannabidiol does not produce a signal for abuse liability in frequent marijuana smokers. Drug Alcohol Depend. 2017 Mar 1;172:9-13. doi: 10.1016/j.drugalcdep.2016.11.030. Epub 2016 Dec 14.

  PMID: 28088032 BACKGROUND

• Philpott HT, O'Brien M, McDougall JJ. Attenuation of early phase inflammation by cannabidiol prevents pain and nerve damage in rat osteoarthritis. Pain. 2017 Dec;158(12):2442-2451. doi: 10.1097/j.pain.0000000000001052.

  PMID: 28885454 BACKGROUND

• Malfait AM, Gallily R, Sumariwalla PF, Malik AS, Andreakos E, Mechoulam R, Feldmann M. The nonpsychoactive cannabis constituent cannabidiol is an oral anti-arthritic therapeutic in murine collagen-induced arthritis. Proc Natl Acad Sci U S A. 2000 Aug 15;97(17):9561-6. doi: 10.1073/pnas.160105897.

  PMID: 10920191 BACKGROUND

• Hammell DC, Zhang LP, Ma F, Abshire SM, McIlwrath SL, Stinchcomb AL, Westlund KN. Transdermal cannabidiol reduces inflammation and pain-related behaviours in a rat model of arthritis. Eur J Pain. 2016 Jul;20(6):936-48. doi: 10.1002/ejp.818. Epub 2015 Oct 30.

  PMID: 26517407 BACKGROUND

• Xiong W, Cui T, Cheng K, Yang F, Chen SR, Willenbring D, Guan Y, Pan HL, Ren K, Xu Y, Zhang L. Cannabinoids suppress inflammatory and neuropathic pain by targeting alpha3 glycine receptors. J Exp Med. 2012 Jun 4;209(6):1121-34. doi: 10.1084/jem.20120242. Epub 2012 May 14.

  PMID: 22585736 BACKGROUND

• Lodzki M, Godin B, Rakou L, Mechoulam R, Gallily R, Touitou E. Cannabidiol-transdermal delivery and anti-inflammatory effect in a murine model. J Control Release. 2003 Dec 12;93(3):377-87. doi: 10.1016/j.jconrel.2003.09.001.

  PMID: 14644587 BACKGROUND

Related Links

• Topical treatments for osteoarthritis of the knee - Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews - NCBI Bookshelf

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Vijay Rasquinha, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

• Robert Duarte, MD

  Northwell Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients, treating physician, and assessors will be blinded to study group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a randomized double blinded parallel group clinical trial to determine safety and efficacy of 35mg CBD patch vs placebo patch in patients with knee osteoarthritis.

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 2, 2020
• Study Start: October 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)