The Relationship Between Cannabis Use, Biomarkers, Tissue Cannabinoid Levels and Clinical Outcomes in Patients With OA

NCT04971629 | Unknown

• 1 other identifier: 20-5918 OA
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• MicroRNAs (Using Next Generation Sequencing)

  Next Generation Sequencing will be used to identify differentially expressed circulating miRNAs in plasma samples.

  Baseline

• Cytokines (High-throughput Luminex-based assays)

  High-throughput ELISA methodology will be used to determine levels of circulating inflammatory cytokines. Cytokines of interest include interferon (IFN)y, interleukin (IL)-1ß, IL-6, IL-8, IL-10, macrophage inflammatory protein (MIP)-1b, tumor necrosis factor (TNF)α\], and metabolic cytokines (Leptin and adiponectin).

  Baseline

• Pain Mediators (High-throughput Luminex-based assays)

  High-throughput ELISA methodology will be used to determine levels of circulating pain mediators. Pain mediators of interest include prostaglandin(PG)E2 and nerve growth factor (NGF).

  Baseline

• Metabolites (Metabolomics Analyses)

  A high throughput metabolomics approach will be used to determine differences in the circulating metabolites that may contribute to patient response to cannabis.

  Day of Surgery

Secondary Outcomes (7)

• Pain Disability Index (PDI)

  Baseline

• Patient Health Questionnaire (PHQ-8)

  Baseline

• Generalized Anxiety Disorder Assessment (GAD-7)

  Baseline

• Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference - Short Form 8a

  Baseline

• Numeric Rating Scale (NRS)- Pain Intensity/Severity

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with knee osteoarthritis (n=600 cannabis users and n=600 cannabis non-users); a subset of the cannabis users (n=100) and cannabis non-users (n=5) will be undergoing total knee replacement surgery.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Pain Services, Toronto General Hospital

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 21, 2021
• Study Start: July 13, 2021
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)