Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons

A Randomized Double-Blinded Crossover Trial Assessing the Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons

This study is being conducted to study the effect of nabilone (a synthetic cannabinoid)on spasticity in spinal cord injured persons.The study will be a phase 2, randomized, placebo-controlled crossover study. Each eligible subject will participate for 26 weeks.Subjects will be randomized to receive either nabilone or placebo during phase 1 of the study. Study drug will be titrated up from 0.5mg daily to a maximum of 3.0 mg daily over the first 11-week phase. Following a 4-week washout period, subjects will be crossed-over to the opposite arm for another 11 week treatment period (phase 2).

Inclusion Criteria:

• Spinal Cord Injury
• 12 months post -injury
• C2-T12, ASIA A-D, stable level of injury
• moderate to severe spasticity or moderate to severe neuropathic pain
• no cognitive impairment
• spasticity medications unchanged for at least 30 days or inadequate pain control at a stabilized dose of either gabapentin or pregabalin for at least 30 days
• no botulinum toxin injections x 6 months

Exclusion Criteria:

• significant cardiovascular disease
• major illness in another body area
• history of psychological disorders or predisposition to psychosis
• sensitivity to cannabinoids
• severe liver disfunction
• history of drug dependancy
• fixed tendon contractures
• used cannabis in the past 30 days
• unwilling to refrain from smoking cannabis during the study
• pregnant or nursing mother