Grant: Team Grant: Cannabis Research in Priority Areas - Multiple Sclerosis

Multiple sclerosis (MS) is a chronic disease that manifests as relapses and/or progression. Multiple disease-modifying treatments (DMTs) are available to control the disease process. Lesser progress has been achieved to treat the multiple symptoms that MS can cause. Persons with MS PwMS, especially after 10 or more years of disease course, are frequently afflicted by a combination of leg weakness with spasticity, neuropathic pains, fatigue, sphincteric dysfunction, sleep disruption, and mood and cognition impairment. These are treated by muscle relaxants, neurotransmitter agents, tricyclics, selective serotonin reuptake inhibitors, and CNS stimulants. The efficacy of these agents, which are fraught with side effects and drug-drug interactions, is often partial. Up to 49% of persons with MS (PwMS), have used cannabis, mostly for mood enhancing, to improve sleep, relieve pain and spasticity. A THC-CBD spray has been approved in Canada in 2005 for symptom improvement in adult PwMS with moderate to severe spasticity who have not responded adequately to other anti-spasticity medications. Now that the use of cannabis is legalized in Canada, the patient and medical communities expect the establishment of evidence-based guidelines for the proper use of cannabis. We are proposing to assess the clinical effects of THC and CBD positive and negative, in a carefully selected cohort of PwMS with single or multiple symptoms, enrolled in a randomized, placebo-controlled, double-blinded, parallel groups trial of four weeks' duration. The main outcomes will be spasticity, with pain, sleep, mood and cognition, fatigue, and sphincteric function as secondary outcomes. The pharmacology of THC-CBD, as well as their effects on neuro-inflammation, will be explored. PwMS will be involved in all phases of the proposed study.