Vaporized Cannabis and Spinal Cord Injury Pain Clinical Trial
Clinical Trials – Neuromuscular Research Center
The Effect of Vaporized Cannabis on Neuropathic Pain in Spinal Cord Injury.
Barth Wilsey, M.D.
This Phase II-III study is an investigator-initiated; double blind, crossover, placebo-controlled study sponsored by the National Institutes of Health. This study is a human laboratory experiment consisting of 3 visits each lasting 8 hours. It will demonstrate that vaporized marijuana results in antinociception (pain relief) when compared to placebo. For each study visit day, a different strength of THC will be given (placebo 0%, low: 2.9%, mild: 6.7%). To further evaluate potential benefits and side effects, the effect of the different strengths of cannabis on mood, cognition, and psychomotor performance will also be measured at every hour of the study day. Neuropsychological tests will be conducted every hour to test hand eye coordination and cognitive ability to think properly. Pen and paper pain/mood self-report questionnaires are also given at every hour.
THC or placebo at multiple doses.
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- Age greater than 18 and less than 70
- ASIA A-D spinal cord injury or disease provided neuropathic pain present as defined as neuropathic pain at- and/or below-level due to trauma or disease (e.g., multiple sclerosis) of the spinal cord or cauda equina with a median pain intensity of 4 on a 0–10 point numeric rating scale (NRS) during a 1-week baseline period. Neuropathic pain will be defined as chronic pain in an area of sensory abnormality corresponding to the spinal cord or nerve root lesion, and the pain should have no primary relation to movement, inflammation or other local tissue damage. Below-level pain will be defined as neuropathic pain present more than three dermatomes below the neurological level and at-level pain as pain located within the dermatome at and three dermatomes below the neurological level
- Leeds Assessment of Neuropathic Symptoms and Signs score greater than or equal to 12, but eligibility is subject to the PI’s clinical assessment
- Spinal cord injury of 3 or more months duration (to avoid spontaneous recovery obfuscating generalizability)
- A negative urine drug screening test, i.e., no evidence of IV drug abuse. If positive for marijuana, subjects must abstain for seven days and be retested. Provided that they meet inclusion/exclusion criteria, subjects will be scheduled for three experimental visits to be described below
- Known concomitant cerebral damage/cognitive impairment (TBI, Alzheimer’s Disease Vascular dementia, Parkinson's disease, dementia with Lewy Bodies and Front temporal dementia
- Clinically significant or unstable medical condition (i.e., severe liver disease or impaired renal function) that, in the opinion of the investigator, would compromise participation in the study
- Neurologic disorders unrelated to spinal cord injury that may confound the assessment of the central neuropathic pain due to spinal cord injury (hereditary neuropathies; diabetic peripheral neuropathy; traumatic neuropathy; and immune-mediated neuropathies)
- Active substance abuse within past year using “The Substance Abuse Module of Diagnostic Interview Schedule for DSM-IV (Appendix 12)
- Current use of marijuana (e.g., within 7 days of randomization)
- Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test
- Currently on probation or parole.
- Hx of Schizophrenia, Bipolar Depression with Mania, current suicidal ideation or past history of suicide attempt