Using Cannabis to Treat Restless Legs Syndrome
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Restless Leg Syndrome (RLS)
In brief
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.
Key facts
- Study ID
- NCT06863740
- Run by
- Sunnybrook Health Sciences Centre
- People needed
- 30
- Starts
- 2025-07-25
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-04-28
Who can join
Age: 25 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥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
You may not qualify if…
- 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
Where it is running
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (enrolling)
- University Health Network — Toronto, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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