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. 2021 Mar;19(3):402–432. doi: 10.2174/1570159X18666200420085712

Table.

e-8. Clinical trials conducted on adults with SCI with cannabinoids interventions searched February 29th, 2020.

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.