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.
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-04-28
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This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Linked local records
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Interventions
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.
MPL-005Placebo oil
Eligibility
primary outcomes
Time frame: 8 weeks
We will measure the rate and type of treatment related adverse events
Time frame: 8 weeks
The percentage of enrolled participants who complete the study
secondary outcomes
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).
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.
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
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.
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).
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.
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).
Time frame: 8 weeks
Ankle actigraphy will be used to count the number of leg movements that occur throughout the night.
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.
Publications
No exact PMID-linked public article is currently readable locally.