Actively Recruiting
Using Cannabis to Treat Restless Legs Syndrome
Led by Sunnybrook Health Sciences Centre · Updated on 2026-04-28
30
Participants Needed
2
Research Sites
92 weeks
Total Duration
On this page
Sponsors
S
Sunnybrook Health Sciences Centre
Lead Sponsor
U
University Health Network, Toronto
Collaborating Sponsor
AI-Summary
What this Trial Is About
Restless Legs Syndrome (RLS) is a disorder that causes painful and uncomfortable sensations in the legs, and its symptoms have a significant impact on sleep and quality of life. Cannabis has been used by some RLS patients as a treatment due to its painkilling and drowsiness effects, however there has never been a clinical research trial investigating cannabis in patients with RLS. A controlled trial is needed to establish how safe and feasible cannabis is as a treatment for RLS. The investigators plan to randomize 30 participants with moderate-to-severe RLS to receive either cannabis or placebo for 8 weeks. The investigators will measure patients sleep quality and quality of life at baseline and 8-week follow-up. The investigators will also monitor patients for any adverse reactions to the study drug.
CONDITIONS
Official Title
Using Cannabis to Treat Restless Legs Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 25 years of age or older
- Diagnosis of Restless Legs Syndrome based on the International RLS Study Group criteria
- Moderate-to-severe RLS symptoms that have not improved with dopaminergic and/or alpha-2-delta ligand therapy
- RLS symptoms present for at least 6 months before screening
You will not qualify if you...
- Sleep disordered breathing that is not well controlled (apnea-hypopnea index greater than 15)
- Cannabis use within 4 weeks before enrollment
- Allergy to cannabis, cannabinoids, or palm/coconut oil
- Currently pregnant or breastfeeding (women of childbearing potential must have a negative urine pregnancy test before treatment)
- Active substance abuse
- Ischemic heart disease with unstable angina or recent acute coronary syndrome in the last 3 months
- Uncontrolled arrhythmias
- Poorly controlled hypertension
- Serious liver disease
- History of schizophrenia or any other psychotic disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
2
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
Research Team
M
Mark Boulos, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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