Actively Recruiting
Cannabis as a Complementary Treatment in Multiple Sclerosis
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2024-12-13
250
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
C
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Multiple sclerosis (MS) is an inflammatory disease of the central nervous system (CNS) afflicting over 77,000 Canadians. Unfortunately, the therapeutic arsenal to relieve MS symptoms is limited. It is therefore essential to develop better approaches to treat the symptoms of MS. The use of cannabis for recreational purposes is now legal in Canada. However, for many years, people with Multiple Sclerosis (PwMS) have used cannabis either to relax, to reduce pain and spasticity, or to improve sleep and daily functioning. Currently, there is little scientifically established evidence that cannabis works on these symptoms in people with MS. It is therefore important to carry out studies to better understand the efficacy Δ-9-tetrahydrocannabinol (THC), and cannabidiol (CBD) on MS symptoms . THC is known for its analgesic, neuroprotective and anti-inflammatory properties and CBD seems to have positive effects on anxiety and cognitive abilities (memory, concentration). For this study, investigators hypothesize that administering different doses of THC alone, CBD alone, and THC and CBD combined will result in a significant beneficial effect on spasticity relief compared to placebo.
CONDITIONS
Official Title
Cannabis as a Complementary Treatment in Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with MS (any subtype) for at least six months by a MS neurologist using the McDonald criteria
- Have spasticity from MS lasting at least one month with a severity of 4 or more on the numerical rating scale
- Stable dose of standard MS therapies for at least 30 days before screening and willing to maintain during the study
- Aged 21 years or older
- Ability and willingness to follow all study requirements
- Ability to read and speak French or English at least at a grade-nine level
You will not qualify if you...
- Have another disease causing spasticity or affecting spasticity levels
- Received botulinum toxin injections within four months prior to screening or unwilling to stop during the study
- Used cannabis or cannabinoid medications within 7 days before study entry and unwilling to abstain during the study
- History of schizophrenia, psychotic illness, or significant psychiatric disorder other than anxiety or depression related to MS
- Alcohol or substance use disorder except nicotine
- History of epilepsy or repeated seizures
- Allergic to cannabinoids or study medication ingredients
- Clinically relevant heart problems within the last 12 months or risk of arrhythmia or heart attack
- Impaired kidney function with creatinine clearance below 50 ml/min
- Significantly impaired liver function or abnormal liver tests
- Pregnant or breastfeeding
- Men with fertility problems planning to conceive
- Planning to conceive during screening or study
- Unable or unwilling to use medically acceptable contraception during the study
- Any other serious disease or condition that poses risk or affects study participation
- Planning international travel or blood donation during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CRCHUM
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
Research Team
P
Pierre Duquette
CONTACT
A
Amel Zertal
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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