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

University of Manitoba

Status and phase: Completed; Phase 2

Conditions: Muscle Spasticity as a Result of Spinal Cord Injury

Treatments: Drug: placebo; Drug: nabilone 0.5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01222468

1976

Details and patient eligibility

About

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).

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

12 participants in 2 patient groups, including a placebo group

nabilone

Active Comparator group

Description:

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

Treatment:

Drug: nabilone 0.5 mg

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo