Actively Recruiting
The Effectiveness of Oral Cannabis Extracts for Osteoarthritic Pain: an Internal Pilot, Placebo Controlled, Blinded Randomized Trial
Led by University Health Network, Toronto · Updated on 2026-04-02
100
Participants Needed
3
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether oral cannabis extracts can help manage pain caused by osteoarthritis (OA), a common joint condition affecting many people. This study aims to evaluate the feasibility of a larger trial comparing the effects of two cannabis compounds, cannabidiol (CBD) and tetrahydrocannabinol (THC), against a placebo on pain interference in patients with hip and/or knee OA. The study addresses the lack of strong scientific evidence despite widespread use of medical cannabis for OA pain relief, and focuses on improving pain management while minimizing side effects. Participants will be randomly assigned to receive either CBD capsules, THC capsules, or placebo capsules daily for 8 weeks. The dose will start low and increase over the first four weeks to find the best balance between pain relief and side effects, then remain steady for the final four weeks. This trial is conducted remotely, with no in-person visits required. After the 8-week treatment, participants will be unblinded and those who stop the cannabis products will be supported with tapering and monitored for an additional 4 weeks. During the study, participants will complete online questionnaires assessing pain severity and interference, physical function, sleep quality, anxiety, depression, and overall quality of life. Follow-ups occur at weeks 1, 2, 3, 4, 6, and 8 after starting treatment, including discussions about treatment effects, side effects, and study drug compliance. The primary outcomes focus on the feasibility of enrollment, adherence to the protocol, and completeness of data up to 8 weeks. Total participation, including tapering if applicable, can last up to 12 weeks.
CONDITIONS
Brief Title
Cannabinoids for Osteoarthritis Pain Effectiveness Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 to 80 years
- Diagnosed with hip and/or knee osteoarthritis as per the American College of Rheumatology criteria
- Experiencing moderate to severe pain interference with a PROMIS-PI SF-6a T-score of 60 or higher
- No new analgesics or osteoarthritis treatments started in the past 4 weeks
- Able to self-report and understand English or French
You will not qualify if you...
- Planned hip or knee surgery within the next 4 months
- Injection into the affected joint(s) within the past 3 months or planned during the trial
- Inflammatory arthritis such as rheumatoid arthritis, psoriatic arthritis, or gout
- Contraindications to cannabis or cannabinoids
- Use of nabilone, nabiximols, or cannabis in the last 30 days
- History of cannabis use disorder or dependence
- Active substance use disorder
- Current diagnosis of bipolar disorder, major depression, or psychosis
- Uncontrolled medical or major psychiatric disorders
- Currently taking warfarin
- Known pregnancy, breastfeeding, or planning pregnancy during or shortly after the study
- No fixed address or plan to move within 4 months
- Known or suspected allergy to palm or coconut oil
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (remote)
Duration - 8 weeks
Participants receive oral capsules containing either CBD, THC, or placebo for osteoarthritis pain. The dose starts at 1 capsule per day and is gradually increased over the first four weeks to a maximum of five capsules per day, then maintained for the remaining four weeks.
6 remote follow-up assessments at weeks 1, 2, 3, 4, 6, and 8
Duration - 4 weeks
Participants who discontinue the investigational products receive support to taper off and have additional follow-ups to monitor progress during the tapering phase. Participants continuing cannabis use receive assistance to secure their own supply.
2 remote follow-up assessments at weeks 10 and 12
Trial Site Locations
Total: 3 locations
1
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
2
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Actively Recruiting
3
McGill University Health Centre/Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Not Yet Recruiting
Research Team
S
Sonal Thaker
D
Deep Grewal
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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