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RECRUITING
NCT06863740
NA

Using Cannabis to Treat Restless Legs Syndrome

Sponsor: Sunnybrook Health Sciences Centre

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

25 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-07-25

Completion Date

2026-05

Last Updated

2025-08-13

Healthy Volunteers

No

Interventions

DRUG

Cannabis oil

5:1 CBD:THC oral formulation with a concentration of 25 mg/g CBD and 5 mg/g THC in a pharmaceutical grade medium chain triglyceride (MCT) oil.

DRUG

Cannabis placebo

Placebo oil

Locations (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada