About this 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.
Eligibility criteria
Qualifiers
≥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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Cannabis oil
- Cannabis placebo
Treatment groups
Sponsors and collaborators
Sunnybrook Health Sciences Centre
Lead sponsor
University Health Network, Toronto
Collaborator