Status:
COMPLETED
Cannabinoids and an Anti-inflammatory Diet for the Treatment of Neuropathic Pain After Spinal Cord Injury
Lead Sponsor:
Eldon Loh, MD
Collaborating Sponsors:
Ontario Neurotrauma Foundation
Conditions:
Spinal Cord Injuries
Neuropathic Pain
Eligibility:
All Genders
25+ years
Phase:
PHASE3
Brief Summary
Neuropathic pain is a common complication following spinal cord injury (SCI) that significantly decreases quality of life. Treatment options are limited, and current treatments can have significant si...
Detailed Description
Nabilone and an anti-inflammatory diet are two novel treatments that may be beneficial for managing Neuropathic Pain (NP) after Spinal Cord Injury (SCI). Neuropathic pain is a common complication fol...
Eligibility Criteria
Inclusion
- Inclusion:
- Age 25 and over, based on year of birth
- Signed informed consent obtained prior to any study-related activities
- BMI 18-40
- A spinal cord injury at least 12 months duration, nonprogressive for at least 6 months
- At- and/or below-level neuropathic pain \>3/10 in severity on the numeric rating scale (NRS) (below-level neuropathic pain will be defined as pain \>1 dermatomal level below the neurologic level of injury). Participants will need an average \>3/10 pain over the past 7 days on screening, and to complete a daily diary for the week prior to randomization in the morning with an average pain severity of \>3/10 on at least 4 diary entries.
- Ongoing constant pain for at least 3 months, or relapsing/remitting pain for at least 6 months.
- Dosing of other pain medications (NSAIDs, opioids, non-opioid analgesics, anti-epileptic drugs, antidepressants) should be stable for at least 1 month prior to study entry.
- Any cannabinoids, or cannabinoid medications (e.g. nabilone) will need to be stopped at least 1 month prior to screening for and inclusion in the study.
- Females of childbearing potential must agree to use a medically approved method of birth control (e.g. hormonal contraceptives, intrauterine devices, vasectomy/tubal ligation, barrier methods and double-barrier method) and must have a negative pregnancy test results at screening and baseline.
- Exclusion:
- History of psychotic disorder
- History of convulsive disorders
- History of substance abuse
- experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months
- Significantly impaired hepatic function at Visit A1 or B1 (Alanine aminotransferase \[ALT\] \>5 upper limit of normal \[ULN\] or total bilirubin \[TBL\] \>2 ULN) OR the ALT or Aspartate aminotransferase (AST) \>3 ULN and TBL \>2 ULN (or international normalized ratio \[INR\] \>1.5)
- Female patients of child bearing potential and male patients whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception, during the study and for three months thereafter
- Female patient who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter
- Current suicidal ideation
- Current use of cannabinoids or cannabinoid medication
- Intolerance to cannabinoids
- Traumatic SCI superimposed on prior congenital stenosis
- Preexisting myelopathy of other causes (e.g. transverse myelitis, epidural abscess, congenital spondylotic myelopathy)
- Presence of other neurologic conditions, medical conditions or pain that could confound the assessment of neuropathic pain after SCI
- Currently enrolled in another clinical trial
- Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, may influence the result of the study, or affect the patient's ability to participate in the study
- Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safe participation in the study
Exclusion
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04057456
Start Date
March 1 2023
End Date
December 1 2024
Last Update
July 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Joseph's Health Care London - Parkwood Institute
London, Ontario, Canada, N6C 0A7