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Recruiting NCT06863740

Using Cannabis to Treat Restless Legs Syndrome

No phase Interventional Restless Leg Syndrome (RLS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cannabis oil, Cannabis placebo.
Who it may be relevant to
Registry conditions: Restless Leg Syndrome (RLS). Basic parameters: from 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug 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.
  • Drug Cannabis placebo
    Placebo oil

Primary outcome measures

  • Incidence of Adverse Events and Serious Adverse Events [Time frame: 8 weeks]
  • Rate of Study Completion [Time frame: 8 weeks]
Secondary outcome measures (9)
  • Change from Baseline in Restless Legs Syndrome Quality of Life (RLSQoL) at 8 Weeks [Time frame: 8 weeks]
  • 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]
  • Change in Restless Legs Syndrome Severity using the International RLS Study Group Rating Scale from Baseline to Follow-up [Time frame: 8 weeks]
  • Change in Sleep Quality as assessed by the Pittsburgh Sleep Quality Index from Baseline to Follow-Up [Time frame: 8 weeks]
  • Change in Daytime Sleepiness as assessed by the Epworth Sleepiness Scale from Baseline to Follow-Up [Time frame: 8 weeks]
  • Change in Mood as assessed by the Beck Depression Inventory from Baseline to Follow-Up [Time frame: 8 weeks]
  • Change in Objective Sleep Quality as Measured by Actigraphy from Baseline to Follow-Up [Time frame: 8 weeks]
  • Change in Leg Movements as Measured by Ankle Actigraphy from Baseline to Follow-Up [Time frame: 8 weeks]
  • Change in Obstructive Sleep Apnea (OSA) Severity (as measured by the apnea-hypopnea index) from Baseline to Follow-Up [Time frame: 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Canada · 2 centers
  • Sunnybrook Health Sciences Centre — Toronto
  • University Health Network — Toronto

Identifiers

NCT: NCT06863740 · 4752

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗