Cannabis for Restless Legs Syndrome
Trial Summary
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have used cannabis within 4 weeks of enrollment.
What evidence supports the effectiveness of cannabis oil as a drug for treating restless legs syndrome?
There is currently insufficient evidence to support the routine use of medicinal cannabis as an effective and safe treatment for sleep disorders, including restless legs syndrome. However, some studies suggest that cannabis may help with symptoms like spasticity and pain in conditions such as multiple sclerosis, which could indicate potential benefits worth further investigation.12345
Is cannabis safe for treating restless legs syndrome?
Cannabis products have been associated with some side effects like nausea, dry mouth, dizziness, and sleepiness, but severe adverse events are relatively low. However, there is not enough evidence to confirm their safety for treating sleep disorders, including restless legs syndrome, and more research is needed.16789
How does cannabis oil differ from other drugs for restless legs syndrome?
What is the purpose of 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
This trial is for individuals with moderate-to-severe Restless Legs Syndrome (RLS), who experience painful sensations in their legs affecting sleep and quality of life. Specific eligibility criteria are not provided, but typically participants must meet certain health standards to be included.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either cannabis or placebo for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cannabis oil
- Cannabis placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor
University Health Network, Toronto
Collaborator