RecruitingNot Applicable

Using Cannabis to Treat Restless Legs Syndrome

Canada30 participantsStarted 2025-07-25

Plain-language 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.

Who can participate

Age range25 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Incidence of Adverse Events and Serious Adverse Events

Timeframe: 8 weeks

Rate of Study Completion

Timeframe: 8 weeks

Trial details

NCT IDNCT06863740

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Mark Boulos, MD

416-480-4473 mark.boulos@sunnybrook.ca