Cannabinoids for Osteoarthritis Pain Effectiveness Trial

NCT06878417 | Recruiting DMC

• 1 other identifier: 24-5572
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

This study aims to investigate whether oral cannabis extracts can effectively manage pain caused by osteoarthritis (OA), a common joint condition affecting one in seven Canadians. Current OA treatments often have limited effectiveness and may cause side effects. As a result, many individuals with OA turn to medical cannabis for pain relief, despite limited scientific evidence supporting its efficacy. The goal of this study is to assess the feasibility of a larger trial evaluating the effects of two cannabis compounds-CBD and THC-compared to a placebo (a look-alike substance containing no active drug) on pain interference in patients with hip and/or knee osteoarthritis. Participants will:

• Take either CBD, THC, or a placebo capsule daily for 8 weeks
• Complete follow-ups remotely, with no in-person clinic visits required
• Maintain a diary tracking their study drug usage and any additional pain medications

Conditions

Osteoarthritis of Knee; Osteoarthritis Hip

Keywords

Medical Cannabis

Outcome Measures

Primary Outcomes (3)

• Feasibility outcome: pertaining to the enrollment rate

  Percentage of eligible and interested patients enrolled

  Through study completion, an average of 1 year

• Feasibility outcome: pertaining to the Protocol adherence

  Percentage of participants with no major protocol deviation (i.e., no concomitant cannabis use or initiation of new OA treatment)

  Up to 8 weeks post-treatment

• Feasibility outcome: pertaining to data completeness

  Percentage of enrolled participants with complete PROMIS Pain Interference data at 8 weeks

  Up to 8 weeks post-treatment

Study Arms (3)

CBD (Cannabidiol)

EXPERIMENTAL

Each capsule contains a concentration of 50 mg of Cannabidiol (CBD). Participants will receive CBD for a total duration of 8 weeks.

Drug: CBD

THC (∆9-tetrahydrocannabinol)

EXPERIMENTAL

Each capsule contains a concentration of 3 mg of ∆9-tetrahydrocannabinol (THC). Participants will receive THC capsules for a total duration of 8 weeks.

Drug: THC

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo capsules for a total duration of 8 weeks.

Drug: Placebo

Interventions

THC DRUG

The starting dose will be 1 capsule per day (3 mg THC) taken orally. The dose will be gradually increased over the first four weeks, based on patient assessment, up to a maximum of five capsules per day (15 mg THC) in divided doses. Once the dose that maximizes potential therapeutic effects while minimizing adverse effects has been determined, it will be maintained for the remaining four weeks of the trial.

Also known as: AVCN319301b

THC (∆9-tetrahydrocannabinol)

CBD DRUG

The starting dose will be 1 capsule per day (50 mg CBD) taken orally. The dose will be gradually increased over the first four weeks, based on patient assessment, up to a maximum of five capsules per day (250 mg CBD) in divided doses. Once the dose that maximizes potential therapeutic effects while minimizing adverse effects has been determined, it will be maintained for the remaining four weeks of the trial.

Also known as: AVCN319301a

CBD (Cannabidiol)

Placebo DRUG

The starting dose will be 1 capsule per day taken orally. The dose will be gradually increased over the first four weeks, based on patient assessment, up to a maximum of five capsules per day in divided doses. Once the dose that maximizes potential therapeutic effects while minimizing adverse effects has been determined, it will be maintained for the remaining four weeks of the trial.

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-80 years
• Diagnosed with hip and/or knee osteoarthritis as per the American College of Rheumatology criteria
• Experiencing moderate to severe pain interference as indicated by a PROMIS-PI SF-6a T-score ≥ 60
• Have not initiated any new analgesics or osteoarthritis treatments in the previous 4 weeks
• Able to self-report, understand and read English or French

You may not qualify if:

• Hip or knee surgery planned in the coming 4 months,
• Injection into the affected joint(s) within the past 3 months (e.g., cortisone, plasma-rich protein, etc.),
• Planned injection into the affected joint(s) during trial period,
• Inflammatory arthritis (e.g., rheumatoid arthritis, Psoriatic arthritis, gout, etc.),
• Contraindications to taking cannabis/cannabinoids,
• Used nabilone or nabiximols in the last 30 days,
• Used cannabis (medical or recreational) in the last 30 days (to allow sufficient washout),
• A history of diagnosed cannabis use disorder or dependence,
• Active substance use disorder,
• Current DSM-V diagnosis of bipolar disorder, major depression, or psychosis,
• An uncontrolled medical or major psychiatric disorder,
• Currently on warfarin,
• Known pregnancy or currently breastfeeding,
• Men and women planning a pregnancy during the study or in the 12 weeks after stopping IPs
• No fixed address or a plan to change addresses in the coming 4 months,

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (3)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

RECRUITING

McGill University Health Centre/Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Dr. Hance Clarke, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonal Thaker

CONTACT

1-416-340-4800; sonalben.thaker@uhn.ca

Deep Grewal

CONTACT

1-416-340-4800; Deep.Grewal@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients, study staff (except the unblinded research assistant who will be preparing and dispensing the IPs), care providers, adjudicators, data analysts, and investigators will be blinded to the active ingredient in the IPs and group allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 17, 2025
• Study Start: January 29, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 2, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)