Recruiting

Cannabis & OA

Sponsor:

University Health Network, Toronto

Code:

NCT04971629

Conditions

Osteo Arthritis Knee

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Osteoarthritis (OA), the most common form of arthritis, is a leading cause of disability, affecting the quality of life, pain, and physical functioning of 4.6 million Canadians. About half of OA patients have limited response to primary therapy. The number of OA patients continues to rise, affecting the quality of life of those with OA. There is a dire need to develop future effective treatment options. Cannabis is a potential therapy for those with OA and may provide analgesic, anti-inflammatory, and disease modifying effects. The common barriers to use are a lack of knowledge regarding efficacy, access, and commonly used products, doses and routes of administration. No high-quality clinical trials of cannabis for OA have been conducted, leaving physicians struggling to guide and inform patients regarding symptom relief. Findings from clinical trials of cannabis for other painful conditions have been variable, perhaps due to suboptimal cannabis products and failure to consider important patient characteristics. The goal of the current study is to characterize patient- and cannabis-level factors that are associated with OA pain and address other knowledge gaps.

Conditions

Osteo Arthritis Knee

Study ID

NCT04971629

Start date

Jul 13, 2021

Status verified date

Nov, 2022

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥25
2. Able to understand and read English
3. Diagnosed with knee OA or seeking treatment for knee related OA
4. Experienced pain in the knee on most days for at least 3 months

Exclusion Criteria:

1. Used cannabis recreationally, but not medically in the past 3 months.
2. Total joint arthroplasty (TJA) within a year of informed consent.

Study Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Patients with knee osteoarthritis who use medical cannabis to manage MSK symptoms.

Cohort 2

Patients with knee osteoarthritis who do not use medical cannabis.

Primary outcome measure

  • MicroRNAs (Using Next Generation Sequencing) [ Time Frame: Baseline ]
  • Cytokines (High-throughput Luminex-based assays) [ Time Frame: Baseline ]
  • Pain Mediators (High-throughput Luminex-based assays) [ Time Frame: Baseline ]
  • Metabolites (Metabolomics Analyses) [ Time Frame: Day of Surgery ]

Central Contacts and Locations

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Orthopaedic Research Office

416-603-5800afazio@uhnresearch.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Nov 14, 2022

Last verified

Nov, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2022-11-14.