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NCT Number: NCT06863740

Using Cannabis to Treat Restless Legs Syndrome

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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Key information

Conditions

Restless Leg Syndrome (RLS) Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Restless Legs Syndrome Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for 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

Treatment and study plan

Cannabis oil

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.

Other names: MPL-005

Cannabis placebo

Drug

Placebo oil

Primary outcomes

  1. Incidence of Adverse Events and Serious Adverse Events

    Time frame: 8 weeks

    We will measure the rate and type of treatment related adverse events

  2. Rate of Study Completion

    Time frame: 8 weeks

    The percentage of enrolled participants who complete the study

Secondary outcomes

  1. Change from Baseline in Restless Legs Syndrome Quality of Life (RLSQoL) at 8 Weeks

    Time frame: 8 weeks

    The Summary Score of the RLSQoL will be calculated, ranging from 0 (worse quality of life) to 100 (best quality of life).

  2. Change from Baseline in Self-Reported Quality of Life on the Short Form-36 (SF-36) Health Survey Questionnaire at 8 Weeks

    Time frame: 8 weeks

    The SF-36 Questionnaire has 36-items that covers eight areas: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scores for each domain range from 0 to 100, with a higher score indicating better health.

  3. Change in Restless Legs Syndrome Severity using the International RLS Study Group Rating Scale from Baseline to Follow-up

    Time frame: 8 weeks

    The International RLS Study Group Rating Scale measures RLS severity based on the following summary scale:

    Very severe=31-40 points Severe=21-30 points Moderate=11-20 points Mild=1-10 points None=0 points

  4. Change in Sleep Quality as assessed by the Pittsburgh Sleep Quality Index from Baseline to Follow-Up

    Time frame: 8 weeks

    Sleep quality as assessed by the Pittsburgh Sleep Quality Index. The questionnaire is scored on a range from 0-21 points, with "0" indicating no difficulty and "21" indicating severe difficulties in all areas.

  5. Change in Daytime Sleepiness as assessed by the Epworth Sleepiness Scale from Baseline to Follow-Up

    Time frame: 8 weeks

    Scores on Epworth Sleepiness Scale range from range from 0 to 24, with higher scores indicating higher average sleep propensity in daily life (daytime sleepiness).

  6. Change in Mood as assessed by the Beck Depression Inventory from Baseline to Follow-Up

    Time frame: 8 weeks

    The Beck Depression Inventory has 21 questions that are scored on a range of 0-63 points. Higher scores indicate more severe depression.

  7. Change in Objective Sleep Quality as Measured by Actigraphy from Baseline to Follow-Up

    Time frame: 8 weeks

    Objective sleep quality will be assessed using wrist actigraphy that will be provided with the home sleep apnea test. Sleep efficiency will be calculated by dividing the amount of time spent asleep (in minutes) by the total amount of time in bed (in minutes).

  8. Change in Leg Movements as Measured by Ankle Actigraphy from Baseline to Follow-Up

    Time frame: 8 weeks

    Ankle actigraphy will be used to count the number of leg movements that occur throughout the night.

  9. Change in Obstructive Sleep Apnea (OSA) Severity (as measured by the apnea-hypopnea index) from Baseline to Follow-Up

    Time frame: 8 weeks

    Measured by the apnea-hypopnea index (AHI). AHI quantifies the number of apneas and hypopneas per hour of sleep. It will be measured using a home sleep monitor or a readout from a continuous positive airway pressure (CPAP) machine.

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Boulos, MD

CONTACT

[email protected]

416-480-4473

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • University Health Network, Toronto

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 7, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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