Table.
Clinical Trial Name |
Registry, Identifier
(Status) |
Phase | Conditions | Interventions | Inclusion Criteria | Exclusion Criteria | Primary Outcomes Measured | Secondary Outcomes Measured |
---|---|---|---|---|---|---|---|---|
Cannabinoids and an Anti-inflammatory Diet for the Treatment of Neuropathic Pain after Spinal Cord Injury | Clinicaltrials.gov, NCT04057456 (Not yet recruiting) |
2 | Spinal Cord Injuries Neuropathic Pain |
Placebo diet Anti-inflammatory diet THC/CBD Capsules High CBD Capsules Placebo capsules |
Informed consent; SCI >12mo duration; neuropathic pain >3/10 in severity on NRS with average >3/10 pain over the past 7d on screening; ongoing constant pain for >3mo or relapsing/remitting pain for >6mo; dosing of other pain medications stable for >1mo; cannabinoids stopped >7d prior to screening | History of psychotic disorder/convulsive disorder/substance abuse, current SI, intolerance to cannabinoids, traumatic SCI superimposed on prior congenital stenosis; pregnancy; unwilling to stop PRN pain medications; other medical conditions that confound the assessment of neuropathic pain | Average Pain intensity; Sensory Changes; Pain relief | Patient global impression of change; Work productivity and activity; Mood; Depression; Sleep; Spasticity; Pro-inflammatory Biomarkers (IL-2, IL-6, IL-1β, tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ) and prostaglandin E2 (PGE2)); Anti-inflammatory Biomarkers (IL-4, IL-10 and IL-1a) |
Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons | Clinicaltrials.gov, NCT01222468 (Completed) |
2 | Muscle Spasticity as a Result of Spinal Cord Injury | Nabilone 0.5mg Placebo |
SCI; 12mo post-injury; C2-T12, ASIA A-D, stable level of injury; moderate to severe spasticity or moderate to severe neuropathic pain; no cognitive impairment; medications unchanged for >30d or inadequate pain control at a stabilized dose of gabapentin/pregabalin for >30d; no botulinum toxin injections <6mo | Significant CVS; major illness in another body area; history of psychological disorders or predisposition to psychosis; sensitivity to cannabinoids; severe liver disfunction; history of drug dependency; fixed tendon contractures; used cannabis <30d; unwilling to refrain from smoking cannabis during the study; pregnant or nursing mother | Ashworth Scale; VAS | Spasticity; Sleep; Subject's Global Impression of Change; Clinician's Global Impression of Change; Pain |
A Study of Cannabis Based Medicine Extracts and Placebo in Patients with Pain Due to Spinal Cord Injury | Clinicaltrials.gov, NCT01606202 (Completed) |
3 | Pain | GW-1000-02 (THC 27mg/ml: CBD 25mg/ml) in 100uL Placebo |
Informed consent; >18yrs; diagnosis of non-acute SCI with central neuropathic pain not wholly relieved by current therapy; central neuropathic pain with mean severity NRS >4 during last 7d of baseline period; stable neurology >6mo; stable medication regimen >4wk; use of contraception during study; no use of cannabinoids >7d, willing to abstain from any use during the study; clinically acceptable laboratory results at visit 2; willingness to comply with all study requirements | History of significant psychiatric disorder other than depression associated with their underlying condition; history of alcohol/substance abuse; severe CVS disorder, (other than atrial fibrillation), poorly controlled htn or severe HF; history of AD, epilepsy; pregnant or nursing mother; significant renal/hepatic impairment; procedures requiring GA during the study; terminal illness; inappropriate for placebo medication; significant disease or disorder in the opinion of the investigator; regular levodopa therapy <7d; known or suspected hypersensitivity/adverse reaction to cannabinoids, intention to travel internationally during the study; intention to donate blood during the study; participation in another research <12wks to study entry; previous randomisation into this study; <18yrs | Mean Central Neuropathic Pain; | Spasticity; Concentration; Quality of Life; Patient Global Impression of Change; Pain; Caregiver Strain; Sleep; Incidence of Adverse Events; Use of Escape Medication |
Abbreviations: AD: autonomic dysreflexia; AS: Ashworth Scale; COPD: chronic obstructive pulmonary disease; CVS: cardiovascular disease; d: day; GA: general anesthetic; HF: heart failure; htn: hypertension; IL: interleukin; mo: month; NRS: numerical rating scale, PRN: as needed; SCI: spinal cord injury; SI: suicidal ideation; SZA: schizophrenia; TB: tuberculosis; TBI: traumatic brain injury; wk: week; yrs: year.