drugset / Trial / NCT06863740

Using Cannabis to Treat Restless Legs Syndrome

NCT06863740 ↗

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-07-25
Primary completion
2026-12
Completion
2027-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabis oil Unknown — Oral