Using Cannabis to Treat Restless Legs Syndrome
Using Cannabis to Treat Restless Legs Syndrome: A Randomized Placebo Controlled Pilot Safety and Feasibility Trial
Sunnybrook Health Sciences Centre
30 participants
Jul 25, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- ≥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 Criteria8
- 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
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Interventions
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.
Placebo oil
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06863740