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Using Cannabis to Treat Restless Legs Syndrome

Restless Leg Syndrome (RLS)

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.

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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    25 and up

Critères de participation

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

Lieu de l'étude

Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Mark Boulos, MD

[email protected]
416-480-4473
University Health Network
University Health Network
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Hance Clarke, MD

[email protected]
416-340-5164
Étude parrainée par
Sunnybrook Health Sciences Centre
Participants recherchés
Plus d'informations
ID de l'étude: NCT06863740