Clinical trial NCT06863740: Using Cannabis to Treat Restless Legs Syndrome
Official title: Using Cannabis to Treat Restless Legs Syndrome: A Randomized Placebo Controlled Pilot Safety and Feasibility Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Restless Leg Syndrome (RLS)
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
First posted: 2025-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Incidence of Adverse Events and Serious Adverse Events
timeFrame: 8 weeks
measure: Rate of Study Completion
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from Baseline in Restless Legs Syndrome Quality of Life (RLSQoL) at 8 Weeks
timeFrame: 8 weeks
measure: Change from Baseline in Self-Reported Quality of Life on the Short Form-36 (SF-36) Health Survey Questionnaire at 8 Weeks
timeFrame: 8 weeks
measure: Change in Restless Legs Syndrome Severity using the International RLS Study Group Rating Scale from Baseline to Follow-up
timeFrame: 8 weeks
measure: Change in Sleep Quality as assessed by the Pittsburgh Sleep Quality Index from Baseline to Follow-Up
timeFrame: 8 weeks
measure: Change in Daytime Sleepiness as assessed by the Epworth Sleepiness Scale from Baseline to Follow-Up
timeFrame: 8 weeks
measure: Change in Mood as assessed by the Beck Depression Inventory from Baseline to Follow-Up
timeFrame: 8 weeks
measure: Change in Objective Sleep Quality as Measured by Actigraphy from Baseline to Follow-Up
timeFrame: 8 weeks
measure: Change in Leg Movements as Measured by Ankle Actigraphy from Baseline to Follow-Up
timeFrame: 8 weeks
measure: Change in Obstructive Sleep Apnea (OSA) Severity (as measured by the apnea-hypopnea index) from Baseline to Follow-Up
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References: