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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Manitoba
• Collaborators: Canadian Paraplegic Association; Health Sciences Centre Foundation, Manitoba; The Manitoba Spinal Cord Injury Research Fund
• Treatments: Dronabinol; Nabilone

Criteria

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