Using Cannabis to Treat Restless Legs Syndrome: A Randomized Placebo Controlled Pilot Safety and Feasibility Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 25
Healthy Volunteers: f
View:

• ≥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

Locations
Other Locations
Canada
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
University Health Network
RECRUITING
Toronto
Contact Information
Primary
Mark Boulos, MD
mark.boulos@sunnybrook.ca
416-480-4473
Time Frame
Start Date: 2025-07-25
Estimated Completion Date: 2026-05
Participants
Target number of participants: 30
Treatments
Experimental: Cannabis Arm
5:1 CBD:THC oral cannabis
Placebo_comparator: Placebo Arm
Oral placebo
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre
Collaborators: University Health Network, Toronto

This content was sourced from clinicaltrials.gov