Using Cannabis to Treat Restless Legs Syndrome

NCT06863740 · tracked via the Priya Life Science Canada tracker

Sponsor

Sunnybrook Health Sciences Centre

Phase

Not applicable

Started

2025-07-25

Last updated

2026-04-28

Condition(s) studied

Restless Leg Syndrome (RLS)

Investigational drug(s) / intervention(s)

Cannabis oil →Cannabis placebo

Cannabis oil: 5:1 CBD:THC oral formulation with a concentration of 25 mg/g CBD and 5 mg/g THC in a pharmaceutical grade medium chain triglyceride (MCT) oil.

Cannabis placebo: Placebo oil

Study summary

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.

Eligibility

Sex

ALL

Min age

25 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * ≥25 years of age * diagnosis of RLS based on the International RLS Study Group criteria * refractory RLS symptoms despite use of dopaminergic and/or alpha-2-delta ligand therapy * onset of RLS at least 6 months before screening Exclusion Criteria: * sleep disordered breathing, or sleep disordered breathing that is not adequately controlled on therapy (apnea-hypopnea index of \>15) * cannabis use within 4 weeks of study enrollment * known allergy to cannabis, cannabinoids or palm/coconut oil * Currently pregnant or breast-feeding (a negative urine pregnancy test must be obtained for women of childbearing potential during pretreatment evaluation) * 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

Primary outcome measure(s)

Incidence of Adverse Events and Serious Adverse Events — 8 weeks
We will measure the rate and type of treatment related adverse events
Rate of Study Completion — 8 weeks
The percentage of enrolled participants who complete the study

Trial sites (2)

Facility	City	Region	Status
Sunnybrook Health Sciences Centre	Toronto	Ontario	Recruiting
University Health Network	Toronto	Ontario	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06863740 on ClinicalTrials.gov ↗ ← All trials in Canada