Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons
- Conditions
- Muscle Spasticity as a Result of Spinal Cord Injury
- Interventions
- Drug: placebo
- Registration Number
- NCT01222468
- Lead Sponsor
- University of Manitoba
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description nabilone nabilone 0.5 mg nabilone 0.5 mg tablets dose-titrated over an 11-week period to a maximum of 3mg po daily. Subjects are allowed to drop back to the previous dose following a dose increase once if required placebo placebo look-alike 0.5 mg placebo tablets titrated to a maximum daily dose of 3.0 mg daily over an 11-week phase. Subjects are allowed to drop back to the previous dose following a dose increase once during the 11-week phase if required
- Primary Outcome Measures
Name Time Method Ashworth Scale 26 weeks A scale that grades resistance to rapid passive movement across a relaxed joint on an ordinal scale of 0 to 4.
VAS (visual analog scale)pain intensity scale 26 weeks Primary outcome measure for pain will be a change in the VAS pain intensity scale. Using a visual intensity scale, patients are asked to record their daily pain score over the previous 24 hours.
- Secondary Outcome Measures
Name Time Method Subject's Global Impression of Change 26 weeks Questionnaire that asks the subject to rate his or her impression of the effects of the study medication.
The Short Form McGill Pain Questionnaire (SF-MPQ) 26 weeks A questionnaire with 3 components: a VAS to determine overall pain levels, a 15-word list of pain descriptors; and a Present Pain Intensity Scale to determine patient's pain at the time of survey completion
VAS Pain Impact Scale 26 weeks A continuous scale measuring the impact of pain with 0mm being non-disruptive and 100 mm being incapacitating
Neuropathic Pain Questionnaire 26 weeks A clinician-administered questionnaire consisting of both sensory descriptors and signs related to bedside sensory examination
Sum of the Ashworth Scale in the eight muscle groups of each side of the body. 26 weeks As above
Pittsburgh Sleep Quality Index 26 weeks Questionnaire that measures patient-reported sleep quality that will be administered at Visits 1,6 and 12
Penn Spasm Frequency Scale 26 weeks Scale graded by study participants to measure frequency of muscle spasms throughout the period in question
Visual Analog Scale 26 weeks Patients rate the intensity of their spasms on a 100 mm pencil and paper VAS scale
Clinician's Global Impression of Change 26 weeks Questionnaire that asks the Clinician to rate his or her impression of the effect of study medication.
Trial Locations
- Locations (1)
Health Sciences Centre Rehabilitation Hospital
🇨🇦Winnipeg, Manitoba, Canada