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?

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.

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 cannabis safe for treating 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. However, there is not enough evidence to confirm their safety for treating sleep disorders, including restless legs syndrome, and more research is needed. ^{1 2 3 4 5}

How does cannabis oil differ from other drugs for restless legs syndrome?

Cannabis oil is unique because it interacts with the body's endocannabinoid system, which may influence sleep and mood, unlike traditional treatments for restless legs syndrome. While there is limited evidence on its effectiveness, it offers a novel approach that warrants further research. ^{1 3 5 6 7}

What evidence supports the effectiveness of cannabis oil as a drug for treating restless legs syndrome?

There is currently insufficient evidence to support the routine use of medicinal cannabis as an effective and safe treatment for sleep disorders, including restless legs syndrome. However, some studies suggest that cannabis may help with symptoms like spasticity and pain in conditions such as multiple sclerosis, which could indicate potential benefits worth further investigation. ^{3 8 9 10 11}

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

I am 25 years old or older.

Diagnosis of RLS based on the International RLS Study Group criteria

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

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]

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]

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. New Zealand pubmed.ncbi.nlm.nih.gov

Is There a Place for Medicinal Cannabis in Treating Patients with Sleep Disorders? What We Know so Far. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

[Cannabinoids in multiple sclerosis -- therapeutically reasonable?]. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Medicinal cannabis extracts for the treatment of multiple sclerosis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

The Effects of Cannabinoids on Sleep. [2022]

7. New Zealand 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

An Updated Analysis of Clinical Outcome Measures Across Patients From the UK Medical Cannabis Registry. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Cannabinoid therapies in the management of sleep disorders: A systematic review of preclinical and clinical studies. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of medicinal cannabis: results of the CaPRis study]. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Cannabis Essential Oil: A Preliminary Study for the Evaluation of the Brain Effects. [2020]