Cannabis oil for restless legs syndrome
Official title: Using Cannabis to Treat Restless Legs Syndrome: A Randomized Placebo Controlled Pilot Safety and Feasibility Trial
Run by Sunnybrook Health Sciences Centre · NCT06863740 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 25 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Status | Recruiting |
| Started | July 25, 2025 |
| Main results expected | December 2026 |
| Study ends | May 2027 |
| Registry record updated | April 28, 2026 |
| Trial ID | NCT06863740 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: There have been no prior randomized clinical trials of cannabis for RLS, though some patients report anecdotal symptom relief.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Crisugabalin for restless legs and variant restless legs
This phase 1 trial will test whether crisugabalin (40 mg twice daily) can reduce symptoms in adults aged 18–75 with moderate to severe restless legs syndrome or its variants over 12 weeks.
-
Spinal cord stimulator effects on restless legs
This study will test whether changing spinal cord stimulator settings alters nerve signals and improves symptoms in people with restless leg syndrome and in some people with chronic pain.
-
Peroneal nerve stimulation for restless legs during pregnancy
This pilot will test whether a wearable TOMAC peroneal nerve stimulator can reduce restless legs symptoms and improve sleep for pregnant people.
-
Observing gene changes in patients with Restless Legs Syndrome on dopamine treatment
This study is trying to see how long-term treatment with dopamine medication affects gene changes in people with Restless Legs Syndrome.
-
Comparing Lemborexant, Zopiclone, and Clonidine for treating insomnia in chronic pain patients
This study is testing whether Lemborexant, Zopiclone, or Clonidine can help people with chronic pain sleep better and manage their pain.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.