Using Cannabis to Treat Restless Legs Syndrome

Sunnybrook Health Sciences Centre

Status: Not yet enrolling

Conditions: Restless Leg Syndrome (RLS)

Treatments: Drug: Cannabis oil; Drug: Cannabis placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06863740

4752

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Cannabis Arm

Experimental group

Description:

5:1 CBD:THC oral cannabis

Treatment:

Drug: Cannabis oil

Placebo Arm

Placebo Comparator group

Description:

Oral placebo

Treatment:

Drug: Cannabis placebo