RecruitingNAINTERVENTIONAL

Using Cannabis to Treat Restless Legs Syndrome

Are you living with Restless Legs Syndrome (RLS) and finding that your current treatments aren't quite enough? This new study is looking into whether cannabis oil could be a helpful option. RLS can cause uncomfortable sensations in your legs, which can really affect your sleep and daily life. While some people with RLS have tried cannabis for its pain-relief and sleep-inducing effects, there hasn't been a proper scientific study to see if it really works and is safe for RLS patients. This research aims to find out. Around 30 participants will receive either cannabis oil or a non-active oil (placebo) for 8 weeks. Researchers will then check if their sleep and overall well-being have improved, and they'll also keep a close eye on any side effects.

At a glance

Status

Recruiting

Phase

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

Start

25 Jul 2025

Estimated completion

01 May 2027

Restless Leg Syndrome (RLS)

What is this study about?

You're probably here because you or someone you know experiences Restless Legs Syndrome, or RLS. It's a condition where you get strong, often uncomfortable, urges to move your legs, especially when you're resting. These feelings can range from itching to aching, and they often make it very hard to get a good night's sleep, which can really impact your energy and mood during the day.

Doctors have noticed that some people with RLS have found relief using cannabis, possibly because it can help with pain and encourage sleepiness. However, this has mainly been through people trying it on their own, not through carefully planned medical studies. To truly know if cannabis is a safe and helpful treatment for RLS, scientists need to study it properly in a controlled environment.

This study aims to do just that. It's designed to see if cannabis oil can make a real difference for people who have RLS that hasn't fully responded to typical medications. The researchers want to understand how it affects your sleep and overall quality of life, and just as importantly, to check if there are any unwanted side effects.

Key takeaways

This study is exploring cannabis oil as a potential treatment for Restless Legs Syndrome (RLS).
It's for people whose RLS symptoms are still troublesome despite taking standard medications.
Participants will receive either cannabis oil or a non-active oil for 8 weeks.
Researchers will check effects on sleep, quality of life, and any side effects.
The goal is to determine if cannabis is safe and effective for RLS.
Joining is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be at least 25 years old and have a confirmed diagnosis of Restless Legs Syndrome that has been bothering you for at least six months. It's important that your RLS symptoms are still troublesome, even if you're already taking commonly prescribed RLS medications like dopaminergics or alpha-2-delta ligands.

There are also some reasons why you might not be able to join. For example, if you have certain sleep problems like severe sleep apnoea that aren't well controlled, or if you've used cannabis in the last four weeks, you wouldn't be eligible. Also, if you're pregnant or breastfeeding, have a serious heart or liver condition, a history of certain mental health conditions like schizophrenia, or are currently dealing with substance abuse issues, this study wouldn't be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 25 years old or older?
Do you have a diagnosis of Restless Legs Syndrome?
Are your RLS symptoms still bothering you, even if you're on medication?
Have you avoided using cannabis in the last four weeks?
Are you not currently pregnant or breastfeeding, and don't have serious heart, liver, or certain mental health conditions?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be one of about 30 people taking part. You'll be randomly chosen to receive either the cannabis oil or a dummy oil (placebo) – neither you nor the study team will know which you're getting. You'll take this assigned oil for 8 weeks. During this time, the researchers will check in with you to see how you're sleeping and how your RLS is affecting your daily life. They'll do these checks at the beginning of the study and again after 8 weeks. They will also carefully monitor you for any side effects or reactions to the study treatment. The total duration of your active participation in the study will be 8 weeks.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as improved sleep and a better quality of life if the cannabis oil helps your RLS symptoms. However, it's also possible that you might receive the dummy oil and not experience any changes, or you might experience side effects from the cannabis oil, which could include drowsiness or changes in appetite. As with any study, there are always some unknown risks involved with new treatments. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada· Recruiting
University Health Network
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is Restless Legs Syndrome?

It's a condition that causes uncomfortable feelings in your legs and a strong urge to move them, often at night, making it hard to sleep.

Will I definitely get cannabis oil?

No, you'll be randomly assigned to either receive cannabis oil or a dummy oil, like flipping a coin. Neither you nor the doctors will know which one you're getting.

How long will the study last for me?

If you enrol, you will take the study treatment for 8 weeks, with assessments at the start and end of this period.

What if I experience side effects?

The study team will closely monitor you for any side effects and will be there to help if you have any concerns during the study.

Can I stop taking part if I change my mind?

Yes, you can choose to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

How to find out more

Mark Boulos, MD

mark.boulos@sunnybrook.ca 416-480-4473 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.