Cannabis for Restless Legs Syndrome

Recruiting at 1 trial location

Overseen By Mark Boulos, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must be taking: Dopaminergic, Alpha-2-delta

Disqualifiers: Sleep apnea, Cannabis use, Pregnancy, Substance abuse, Heart disease, Liver disease, Schizophrenia, others

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if cannabis can safely and effectively alleviate symptoms for people with Restless Legs Syndrome (RLS). RLS causes uncomfortable sensations in the legs, disrupting sleep and daily life. Participants will receive either cannabis oil (a liquid form of cannabis) or a placebo to assess its impact on sleep and overall quality of life. Individuals who have experienced moderate-to-severe RLS for at least six months, despite trying other treatments, may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore new treatment possibilities for RLS.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have used cannabis within 4 weeks of enrollment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that cannabis may help alleviate symptoms of restless legs syndrome (RLS), with some patients reporting significant relief. Research suggests that cannabis is generally safe, with no known lethal dose for its main components, THC and CBD.

Cannabis can cause mild side effects such as nausea, dry mouth, dizziness, and sleepiness, but serious issues are rare. It's important to note that while cannabis helps some individuals, controlled trials have not yet proven its safety or effectiveness for RLS. Therefore, further research, such as this study, is necessary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Restless Legs Syndrome, which often involve medications like dopamine agonists or anticonvulsants, the cannabis oil being studied offers a unique approach by using a combination of CBD and THC. Researchers are excited about this treatment because it targets the endocannabinoid system, potentially providing relief through a different mechanism than traditional drugs. Additionally, the 5:1 CBD to THC ratio aims to maximize therapeutic benefits while minimizing psychoactive effects, offering a promising alternative for those who may not find relief with existing medications.

What evidence suggests that cannabis might be an effective treatment for Restless Legs Syndrome?

Research suggests that cannabis might help with symptoms of Restless Legs Syndrome (RLS). In one study, patients who smoked cannabis reported almost complete relief from their symptoms, although they continued using other treatments. Another study found that a combination of CBD and THC (two compounds in cannabis) improved sleep quality, which is often a problem for people with RLS. However, some studies show that CBD alone did not help with RLS symptoms in patients with other conditions, like Parkinson's disease. This trial will compare the effects of a 5:1 CBD:THC oral cannabis formulation, given to participants in the Cannabis Arm, with a placebo, given to participants in the Placebo Arm. While the research is promising, more studies are needed to confirm how effective cannabis is for RLS. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with moderate-to-severe Restless Legs Syndrome (RLS), who experience painful sensations in their legs affecting sleep and quality of life. Specific eligibility criteria are not provided, but typically participants must meet certain health standards to be included.

Inclusion Criteria

Diagnosis of RLS based on the International RLS Study Group criteria

I am 25 years old or older.

I have had restless legs syndrome for at least 6 months.

Exclusion Criteria

Active substance abuse

History of schizophrenia or any other psychotic disorder

Cannabis use within 4 weeks of study enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either cannabis or placebo for 8 weeks

8 weeks

Baseline visit and regular monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

8-week follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

• Cannabis oil
• Cannabis placebo

Trial Overview The study is testing the effects of cannabis oil compared to a placebo on RLS symptoms. Thirty participants will be randomly assigned to receive either the actual treatment or placebo for 8 weeks, with evaluations of sleep quality and overall well-being before and after treatment.

How Is the Trial Designed?

Group I: Cannabis Arm Experimental Treatment 1 Intervention

5:1 CBD:THC oral cannabis

Group II: Placebo Arm Placebo Group 1 Intervention

Oral placebo

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Sativex® (THC:CBD) has been used for over 45,000 patient-years in treating treatment-resistant spasticity in multiple sclerosis, with a registry study involving 941 patients showing that 83% reported benefits from the treatment.

The long-term safety profile of Sativex® appears consistent with known safety data, with only 6% of patients experiencing significant psychiatric adverse events and no new long-term safety concerns identified, indicating it is well-tolerated for MS spasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland who have been prescribed Sativex® (THC:CBD, nabiximols) oromucosal spray. Etges, T., Karolia, K., Grint, T., et al.[2022]

In an eight-week clinical trial involving 17 women with fibromyalgia, a THC-rich cannabis oil significantly reduced symptoms and improved quality of life compared to a placebo, as measured by the Fibromyalgia Impact Questionnaire.

The cannabis group showed notable improvements in specific symptoms such as pain, fatigue, and overall well-being, with no intolerable adverse effects reported, suggesting that phytocannabinoids could be a safe and effective treatment option for fibromyalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ingestion of a THC-Rich Cannabis Oil in People with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Chaves, C., Bittencourt, PCT., Pelegrini, A.[2021]

A systematic review of 14 preclinical and 12 clinical studies found insufficient evidence to support the routine use of cannabinoids like THC and CBD for treating sleep disorders due to moderate-to-high risk of bias in the studies.

Despite the lack of conclusive evidence, there is promising preliminary data that suggests cannabinoids may be beneficial for specific sleep disorders, highlighting the need for more rigorous and controlled trials in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabinoid therapies in the management of sleep disorders: A systematic review of preclinical and clinical studies. Suraev, AS., Marshall, NS., Vandrey, R., et al.[2021]

The analysis of 16 systematic reviews and 9 additional randomized-controlled trials found that medicinal cannabis can effectively help manage chronic pain and spasticity in multiple sclerosis patients, as well as stimulate appetite and improve nausea in cancer and HIV/AIDS patients, although the benefits are often small.

While there are reported adverse effects associated with cannabis medicine, severe adverse effects are rare, highlighting the need for more extensive and methodologically sound studies to establish reliable treatment guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of medicinal cannabis: results of the CaPRis study]. Hoch, E., Friemel, C., Schneider, M., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07224932

Tolerability and Efficacy of CBD Extract for RLS Treatment The RLS-6 Severity Scale ranges from 0-60; increasing scores indicates a worse outcome. The International Restless Legs Syndrome Study Group ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35749710/

The Effect of Cannabidiol for Restless Legs Syndrome ... Conclusion: CBD showed no reduction in the severity of RLS/WED manifestation in patients with PD and RBD. Keywords: Parkinson's disease; Willis- ...

3. azmedmj.com azmedmj.com/sites/default/files/2023-12/More%20evidence%20of%20cannabis%20efficacy%20in%20restless%20legs%20syndrome%20%281%29.pdf

More evidence of cannabis efficacy in restless legs syndrome All but one patient (patient 2) admitted total relief of symp- toms following cannabis smoking but none discontinued cur- rent RLS treatment mainly because of ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923011911

Effects of Cannabinoids on Sleep and their Therapeutic ... Studies of CBD in combination with THC have shown that CBD has more alerting effects ... More evidence of cannabis efficacy in restless legs syndrome. Sleep ...

5. cannakeys.com cannakeys.com/thc-cbd-for-restless-leg-syndrome/

Restless Leg Syndrome - Cannabis THC : CBD Ratios CannaKeys has 12 studies associated with Restless Leg Syndrome. Here is a small sampling of Restless Leg Syndrome studies by title.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06863740

Using Cannabis to Treat Restless Legs Syndrome 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8116407/

Effects of Cannabinoids on Sleep and their Therapeutic ... Further, in the absence of other robust clinical data, routine use cannot be recommended for RLS or PLMS at this time.

8. sleepfoundation.org sleepfoundation.org/sleep-aids/cannabis-and-sleep

Cannabis for Sleep: Benefits and Risks ... cannabis may relieve symptoms for people with restless legs syndrome (RLS). ... safe — there's no lethal dose for either THC or CBD.

9. withpower.com withpower.com/trial/phase-restless-legs-syndrome-2-2025-b8fe6

Cannabis for Restless Legs Syndrome Cannabis products have been associated with some side effects like nausea, dry mouth, dizziness, and sleepiness, but severe adverse events are relatively low.