Phase 3
Completed N=42
Vaporized Cannabis and Spinal Cord Injury Pain
Spinal Cord Injuries · Spinal Cord Diseases
Source: ClinicalTrials.gov NCT01555983 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: Number of Participants Achieving a Reduction in Pain Intensity of 30% or More — 18; 26; 35 participants — p=<.05
Summary
This study will demonstrate that vaporized marijuana results in antinociception when compared to placebo in subjects with spinal cord injury. To further evaluate potential benefits and side effects, the effect of different strengths of cannabis on mood, cognition, and psychomotor performance will also be measured.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving a Reduction in Pain Intensity of 30% or More |
18; 26; 35 | <.05 sig |
Eligibility Criteria
Inclusion Criteria
- Age greater than 18 and less than 70
- Pain intensity ≥ 4/10
- Neuropathic pain 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
- Leeds Assessment of Neuropathic Symptoms and Signs score greater than or equal to 12
- Spinal cord injury of 3 or more months duration (to avoid spontaneous recovery obfuscating generalizability)
Exclusion Criteria
- 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., cardiac, respiratory, hepatic or renal disease) 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
- 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 8. Severe depression (Patient Health Questionnaire-9 ≥ 15) 9. Current suicidal ideation
Data sourced from ClinicalTrials.gov (NCT01555983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.