Randomized Double Blind Cross Over Study for Nabilone in Spasticity in Spinal Cord Injury Persons

Study Overview
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Brief Summary
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Objectives: To determine whether nabilone, a synthetic cannabinoid, alleviates spasticity in people with spinal cord injury (SCI). Methods: Twelve subjects were enrolled in this double-blind, placebo-controlled, crossover study. They received either nabilone or placebo during the first four-week period (0.5mg OD with option to increase to 0.5mg BID), then outcome measures were assessed. After a two-week washout, subjects were crossed-over to the opposite arm. The primary outcome was the Ashworth scale for spasticity in the most involved muscle group, chosen by the subject and clinician. The secondary outcomes included Spasm Frequency Scale, Visual Analog Scale, Wartenberg Pendulum Test, sum of the Ashworth Scale in eight muscle groups of each side of the body, and the Clinician's and Subject's Global Impression of Change .

Official Title
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Randomized Double Blind Cross Over Study Assessing the Effect of Cannabiniods on Spasticity in Spinal Cord Injured Persons :A Pilot Study

Conditions
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Spasticity in Spinal Cord Injured Persons

Intervention / Treatment
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* Drug: nabilone then placebo
* Drug: placebo then nabilone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with spinal cord injury were eligible for the study if they are 18-65 years old, have C5 (ASIA A-D) and below and the injury occurred greater than 1 year previously. They had to have stable neurological level of injury with moderate spasticity (Ashworth >/= 3) and no cognitive impairments. The spasticity medications needed to be unchanged for at least 30 days before inclusion, and no botulinum toxin injections for > 4 months. Exclusion Criteria: They were excluded if they had: Heart disease as cannabinoids can reduce heart rate and blood pressure History of psychotic disorders, schizophrenia or any active psychological disorder Previously documented sensitivity to marijuana or other cannabinoid agents Severe liver dysfunction Cognitive impairment Major illness in another body area If they were pregnant or nursing mother Had history of drug dependency Used smoked cannabis < 30 days before the onset of the study or were unwilling not to smoke during the study; OR If they fixed tendon contractures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>first on treatment then on Placebo | Drug: nabilone then placebo<br>* The subjects were first on Nabilone, then crossed over to placebo<br>|
| Placebo Comparator: 2<br>first on placebo then on treatment | Drug: placebo then nabilone<br>* the subjects were first on placebo then crossed over to nabilone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ashworth scale in most involved group muscles |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcomes included Spasm Frequency Scale, Visual Analog Scale, Wartenberg Pendulum Test, sum of the Ashworth Scale in eight muscle groups of each side of the body, and the Clinician's and Subject's Global Impression of Change . |  | 10 weeks |