Using Cannabis to Treat Restless Legs Syndrome
Key facts
- Where
- Toronto, CanadaSee the 2 sites
Where in Canada
- Sunnybrook Health Sciences CentreToronto, CanadaContact: Mark Boulos, MDTaking people
- University Health NetworkToronto, CanadaContact: Hance Clarke, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sunnybrook Health Sciences Centre
- Trial code
- NCT06863740
- Record updated
- 28 April 2026
- Original description
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.Read full original descriptionShow less
Using Cannabis to Treat Restless Legs Syndrome: A Randomized Placebo Controlled Pilot Safety and Feasibility Trial
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.
Inclusion: ≥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: sleep disordered breathing, or sleep disordered breathing that is not adequately controlled on therapy (apnea-hypopnea index of >15); known allergy to cannabis, cannabinoids or palm/coconut oil; 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; cannabis use within 4 weeks of study enrollment; Currently pregnant or breast-feeding (a negative urine pregnancy test must be obtained for women of childbearing potential during pretreatment evaluation); Active substance abuse.