Cannabis oil for restless legs syndrome
Using Cannabis to Treat Restless Legs Syndrome: A Randomized Placebo Controlled Pilot Safety and Feasibility Trial
This trial will test whether cannabis oil helps adults with moderate-to-severe restless legs syndrome feel less leg discomfort and sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 25 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT06863740 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled trial will enroll 30 adults with moderate-to-severe RLS that has not responded to dopaminergic or alpha-2-delta ligand therapies. Participants will be randomly assigned to receive cannabis oil or a matching placebo for eight weeks, with sleep quality and quality of life measured at baseline and at eight-week follow-up. Investigators will monitor for adverse reactions and document feasibility and tolerability of cannabis in this population. The study is being conducted at Sunnybrook Health Sciences Centre and University Health Network in Toronto, Ontario.
Who should consider this trial
Good fit: Adults aged 25 and older with a confirmed RLS diagnosis, symptom onset at least six months earlier, and moderate-to-severe symptoms refractory to dopaminergic or alpha-2-delta ligand therapy are the intended participants.
Not a fit: People with uncontrolled sleep-disordered breathing, recent cannabis use, active substance abuse, pregnancy or breastfeeding, serious cardiac or liver disease, or a history of psychotic disorders may not be eligible and are unlikely to benefit from this treatment.
Why it matters
Potential benefit: If successful, cannabis oil could reduce RLS symptoms and improve sleep and quality of life for patients who have not benefited from standard medications.
How similar studies have performed: There have been no prior randomized clinical trials of cannabis for RLS, though some patients report anecdotal symptom relief.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toronto, Ontario and 1 other locations
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
- University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Mark Boulos, MD
- Email: mark.boulos@sunnybrook.ca
- Phone: 416-480-4473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.