Using Cannabis to Treat Restless Legs Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-25

Study Completion Date

2026-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Restless Leg Syndrome (RLS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cannabis Arm

5:1 CBD:THC oral cannabis

Group Type EXPERIMENTAL

Cannabis oil

Intervention Type DRUG

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.

Placebo Arm

Oral placebo

Group Type PLACEBO_COMPARATOR

Cannabis placebo

Intervention Type DRUG

Placebo oil

Interventions

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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.

Intervention Type DRUG

Cannabis placebo

Placebo oil

Intervention Type DRUG

Other Intervention Names

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MPL-005

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No