Spinal Cord InjuriesPhase 3CATNPNCT04057456
Cannabinoids and an Anti-inflammatory Diet for the Treatment of Neuropathic Pain After Spinal Cord Injury
A Phase 3 study testing Anti-inflammatory diet and Nabilone Capsules in people with Spinal Cord Injuries and Neuropathic Pain, run by Eldon Loh, MD at 1 site in Canada.
Trial 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 side effects. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Spinal Cord Injuries, Neuropathic Pain
- What is being tested?
- Anti-inflammatory diet and Nabilone Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2023to 1 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph's Health Care London - Parkwood Institute
London, Ontario, N6C 0A7
About this study
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 side effects. Those with SCI have identified a need for additional treatment options, particularly those that are not medications. Nabilone and an anti-inflammatory diet are two treatments that may provide pain relief while being better tolerated. This study will evaluate the benefits of these treatments for neuropathic pain after SCI. Study participants will receive either an anti-inflammatory diet or a placebo diet, and nabilone or a placebo for 4 weeks. It is expected that an anti-inflammatory diet and nabilone will significantly decrease pain intensity and improve function. The combination of both treatments together is expected to have a greater effect than each alone.
Read the 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 following SCI that significantly decreases quality of life. Treatment options are limited, and current treatments can have significant side effects. Those with SCI have identified a need for additional treatment options, particularly those that are not medications. Cannabinoids and an anti-inflammatory diet may provide pain relief while being better tolerated.
The Co- Sponsor Investigators will test the potential benefits of these treatments for neuropathic pain after SCI.
Clinically, cannabinoids have been shown to be effective in the management of central NP after multiple sclerosis (MS), and although they have been trialed for a variety of complications after SCI, direct evidence for their ability to manage NP in this population is limited. Further, no studies have evaluated the efficacy of synthetic cannabinoids (nabilone) for the treatment of NP after SCI. Accordingly, the CanPainSCI Clinical Practice Guidelines concluded that the evidence is insufficient to develop a specific recommendation regarding cannabinoids in the treatment of NP after SCI. In addition, relevant side effects for those with SCI have not been well documented. Despite this, cannabinoids have been increasingly used as a treatment option for NP after SCI, particularly given increased access to, and greater societal acceptance of, cannabinoids in general. Studies that evaluate the effectiveness and side effects of cannabinoids and synthetic cannabinoids in the SCI population are therefore urgently needed.
An anti-inflammatory diet has recently shown promise in the management of NP after SCI. An RCT comparing an anti-inflammatory diet to placebo identified a reduction in sensory NP symptoms following SCI. This RCT was done in a general population of SCI patients and did not necessarily select those who were experiencing significant neuropathic pain. Therefore, additional evidence to demonstrate treatment effect will be important to justify widespread adoption of this diet for NP after SCI.
The study will collect data on a sample of up to 140 patients with SCI and at- and/or below-level neuropathic pain >3/10 in severity on the numeric rating scale.
The Principal Investigators will assess the treatment's effects on quality of life and pain management. If the study is successful, the results (and an evaluation of the process) will be used to inform an affordable and sustainable anti-inflammatory nutrition program to be implemented at Power Cord. This nutrition program will also be widely disseminated and potentially act as a template for similar programs In SCI care centres across Canada.
This study will assess blood samples at three time points for analysis of pro and anti-inflammatory markers. The research coordinator (blinded to the randomization) will assess patients using various quality of life and pain assessment questionnaires during clinic visits, at home or by telephone interview.
The type, level, and completeness of injury will be documented, and, if necessary, updated at each in-person visit. Each participant will be provided with instructions and study schedule. Protocol compliance will be tested through product count and interviews at each follow-up visit. Side effects will be assessed using standardized case report forms at each visit. Study visits may be in person or over the phone. Participants will be encouraged to report any events they may experience directly to the coordinator.
Participants who withdraw consent to continue treatments, will be encouraged to undergo the planned assessments. Withdrawal at the request of investigators or medical personnel may include, but are not limited to:
- Symptoms are deemed to be potentially related to the study product
- New diagnosis of exclusion criteria;
- Unacceptable side effects;
- Death
Estimated time to complete recruitment: Averaging 36 months, approximately 3 years.
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Being tested
- Placebo diet, Anti-inflammatory diet, Nabilone Capsules, Placebo capsules
- Keywords
- Nabilone, Spinal Cord Injury, Neuropathic pain, Pain, Anti Inflammatory Diet
- Medical subject headings
- Spinal Cord Injuries, Neuralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo dietOther
The dietitian will assist in developing a diet that is isocaloric to the anti-inflammatory diet and healthy (for the sake of the participants' well-being, and to blind participants), while allowing many foods that are (counterintuitively) pro-inflammatory (e.g. whole wheat bread, white beans, oats, soy, eggplant, raspberries, pumpkin seeds, popcorn, etc). Occasional "cheat" foods are built into the placebo diet but with more pro-inflammatory options (e.g. two glasses of wine per week).
Anti-inflammatory dietOther
Participants will also be given a list of foods that they are allowed on the anti-inflammatory diet, and a list of foods to avoid so that they can make informed substitutions to the meals and ingredients that they are given. The study participants will be given a one-week meal plan with accompanying recipes. Occasional "cheat" foods are built into the anti-inflammatory diet (e.g. two bottles of beer per week)
Nabilone CapsulesDrug
Capsules will be 0.5mg nabilone. Participants will undergo a 5-week titration period by taking 1 (0.5mg) nabilone capsule per day for a three-day period. The dose will be increased on a fixed schedule by 1 (0.5mg) capsule every three days to a maximum of 8 capsules/day (4mg). Dosage will be maintained if higher doses are not tolerated or if sufficient relief is obtained (at least a 2-point change on the NRS). Once the appropriate nabilone (or placebo) dosage for each participant is determined, participants will begin their respective interventions over the course of the 4-week treatment period.
Placebo capsulesOther
Placebo capsules contain no active ingredient. Participants on placebo capsules will undergo the same 5-week titration period and intervention period as those on active treatment.
| Study group | Role | What they receive |
|---|---|---|
| Placebo diet and placebo capsules | Placebo comparator | Participants taking the placebo diet and capsules Receives: Other: Placebo diet; Other: Placebo capsules |
| Placebo diet and Nabilone capsules | Active comparator | Capsules will be 0.5mg nabilone. Participants will take up to 8 capsules per day for a maximum dose of 4mg of nabilone per day. Receives: Other: Placebo diet; Drug: Nabilone Capsules |
| Anti-inflammatory diet and placebo capsules | Active comparator | This meal plan will eliminate foods that have been established as pro-inflammatory (e.g. processed foods, refined sugars, refined wheat products, etc.) as well as foods that are commonly associated with even mild intolerances (e.g. cow's milk) and those that negatively impact cardiovascular health (e.g. hydrogenated oils, alcohol, coffee, refined sugars and wheat, trans fats, processed foods). In their place, the meal plan will consist of foods with established anti-inflammatory properties (e.g. (Oily fish, lean poultry, dark leafy greens, cruciferous vegetables, nuts, whole grains, most kinds of berries, etc). Receives: Other: Anti-inflammatory diet; Other: Placebo capsules |
| Anti-inflammatory diet and Nabilone capsules | Active comparator | Capsules will be 0.5mg nabilone. Participants will take up to 8 capsules per day for a maximum dose of 4mg of nabilone per day.
This meal plan will eliminate foods that have been established as pro-inflammatory (e.g. processed foods, refined sugars, refined wheat products, etc.) as well as foods that are commonly associated with even mild intolerances (e.g. cow's milk) and those that negatively impact cardiovascular health (e.g. hydrogenated oils, alcohol, coffee, refined sugars and wheat, trans fats, processed foods). In their place, the meal plan will consist of foods with established anti-inflammatory properties (e.g. (Oily fish, lean poultry, dark leafy greens, cruciferous vegetables, nuts, whole grains, most kinds of berries, etc). Receives: Other: Anti-inflammatory diet; Drug: Nabilone Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average pain intensity
Change from baseline to end of study in average pain intensity evaluated using the Numeric Rating Scale, which measures pain using a scale of 1-10 (1 being mild, and 10 being severe)
Measured: Baseline and 9 weeks
Sensory changes
Changes from baseline to end of study in the items on the Neuropathic Pain Questionnaire
Measured: Baseline and 9 weeks
Pain relief
Proportion of participants achieving at least 30% and 50% pain relief between treatments.
Measured: Baseline and 9 weeks
Secondary outcomes (8)
Patient global impression of change
Change from first study visit to end of study in the patient global impression of change questionnaire
Measured: Baseline and 9 weeks
Financial feasibility of following anti-inflammatory diet
This will be analyzed using a cost estimate created by the study team, and will be compared to the Productivity Costs Questionnaire which assesses participant's income.
Measured: 9 weeks
Mood Centre for Epidemiologic Studies-Depression scale
Changes from baseline to end of study in mood, assessed by the Mood Centre for Epidemiologic Studies Depression Scale, which has 20 questions that can be answered using four options: Rarely, Some or a little of the time, Occasionally, and Most or all of the time.
Measured: Baseline and 9 weeks
Sleep
Changes from baseline to end of study in sleep assessed by Leeds Sleep Evaluation Questionnaire
Measured: Baseline and 9 weeks
Spasticity
Changes from baseline to end of study in spasticity documented using the SCI-Spasticity Evaluation Tool (SCI-SET)
Measured: Baseline and 9 weeks
Pro-Inflammatory biomarkers
Changes from baseline to end of study in blood inflammatory biomarkers interleukin-2 (IL-2), IL-6, IL-1β, tumor necrosis factor alpha (TNF-α), interferon gamma (IFN-γ) and prostaglandin E2 (PGE2) will be evaluated through blood collection and analysis using an ELISA analysis.
Measured: Baseline and 9 weeks
Profile of Mood States
Change from baseline to end of study in Profile of Mood States questionnaire, this questionnaire evaluates what different types of moods the participant has felt and rates each mood into 5 possible answers: Not At All, A Little, Moderately, Quite a lot, Extremely.
Measured: Baseline and 9 weeks
Anti-Inflammatory Biomarkers
Changes from baseline to end of study in blood anti-inflammatory biomarkers IL-4, IL-10 and IL-1a will be evaluated through blood collection and analysis using an ELISA analysis.
Measured: Baseline and 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 Mar 2023
- Primary completion1 May 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Eligible participants who consent to study participation will be randomized to one of four groups: 1) Nabilone and Placebo Diet, 2) Placebo Capsule and Anti-inflammatory Diet, 3) Nabilone and Anti-inflammatory Diet, and 4) Placebo Capsule and Placebo Diet. Following randomization, participants will begin a study agent titration period (nabilone or placebo) in order to determine a safe and effective nabilone dose for each participant. Once the appropriate nabilone (or placebo) dosage for each participant is determined, participants will begin their respective interventions over the course of the 4-week treatment period. All outcome measures will be at assessed baseline, after the study agent titration period, and post-testing (following the 4-week treatment period).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eldon Loh, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Responsible party
- Sponsor-investigator, Eldon Loh, MD, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Eldon Loh, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sDavid Ditor, MD, Principal investigator, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057456
- Sponsor's protocol ID
- 6465
- Acronym
- CATNP
- Status last verified
- Jul 2025
- First submitted
- 1 Aug 2019
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loh E, Guy SD, Mehta S, Moulin DE, Bryce TN, Middleton JW, Siddall PJ, Hitzig SL, Widerstrom-Noga E, Finnerup NB, Kras-Dupuis A, Casalino A, Craven BC, Lau B, Cote I, Harvey D, O'Connell C, Orenczuk S, Parrent AG, Potter P, Short C, Teasell R, Townson A, Truchon C, Bradbury CL, Wolfe D. The CanPain SCI Clinical Practice Guidelines for Rehabilitation Management of Neuropathic Pain after Spinal Cord: introduction, methodology and recommendation overview. Spinal Cord. 2016 Aug;54 Suppl 1:S1-6. doi: 10.1038/sc.2016.88.
PubMed 27444714Guy SD, Mehta S, Casalino A, Cote I, Kras-Dupuis A, Moulin DE, Parrent AG, Potter P, Short C, Teasell R, Bradbury CL, Bryce TN, Craven BC, Finnerup NB, Harvey D, Hitzig SL, Lau B, Middleton JW, O'Connell C, Orenczuk S, Siddall PJ, Townson A, Truchon C, Widerstrom-Noga E, Wolfe D, Loh E. The CanPain SCI Clinical Practice Guidelines for Rehabilitation Management of Neuropathic Pain after Spinal Cord: Recommendations for treatment. Spinal Cord. 2016 Aug;54 Suppl 1:S14-23. doi: 10.1038/sc.2016.90.
PubMed 27444715Allison DJ, Thomas A, Beaudry K, Ditor DS. Targeting inflammation as a treatment modality for neuropathic pain in spinal cord injury: a randomized clinical trial. J Neuroinflammation. 2016 Jun 17;13(1):152. doi: 10.1186/s12974-016-0625-4.
PubMed 27316678Fine PG, Rosenfeld MJ. Cannabinoids for neuropathic pain. Curr Pain Headache Rep. 2014 Oct;18(10):451. doi: 10.1007/s11916-014-0451-2.
PubMed 25160710Nielsen S, Germanos R, Weier M, Pollard J, Degenhardt L, Hall W, Buckley N, Farrell M. The Use of Cannabis and Cannabinoids in Treating Symptoms of Multiple Sclerosis: a Systematic Review of Reviews. Curr Neurol Neurosci Rep. 2018 Feb 13;18(2):8. doi: 10.1007/s11910-018-0814-x.
PubMed 29442178Eisenstein M. Medical marijuana: Showdown at the cannabis corral. Nature. 2015 Sep 24;525(7570):S15-7. doi: 10.1038/525S15a. No abstract available.
PubMed 26398734Langford RM, Mares J, Novotna A, Vachova M, Novakova I, Notcutt W, Ratcliffe S. A double-blind, randomized, placebo-controlled, parallel-group study of THC/CBD oromucosal spray in combination with the existing treatment regimen, in the relief of central neuropathic pain in patients with multiple sclerosis. J Neurol. 2013 Apr;260(4):984-97. doi: 10.1007/s00415-012-6739-4. Epub 2012 Nov 21.
PubMed 23180178Mucke M, Phillips T, Radbruch L, Petzke F, Hauser W. Cannabis-based medicines for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2018 Mar 7;3(3):CD012182. doi: 10.1002/14651858.CD012182.pub2.
PubMed 29513392Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.
PubMed 19362699Ware MA. Medical Cannabis Research: Issues and Priorities. Neuropsychopharmacology. 2018 Jan;43(1):214-215. doi: 10.1038/npp.2017.222. No abstract available.
PubMed 29192670Karschner EL, Darwin WD, McMahon RP, Liu F, Wright S, Goodwin RS, Huestis MA. Subjective and physiological effects after controlled Sativex and oral THC administration. Clin Pharmacol Ther. 2011 Mar;89(3):400-7. doi: 10.1038/clpt.2010.318. Epub 2011 Feb 2.
PubMed 21289620De Gregorio D, McLaughlin RJ, Posa L, Ochoa-Sanchez R, Enns J, Lopez-Canul M, Aboud M, Maione S, Comai S, Gobbi G. Cannabidiol modulates serotonergic transmission and reverses both allodynia and anxiety-like behavior in a model of neuropathic pain. Pain. 2019 Jan;160(1):136-150. doi: 10.1097/j.pain.0000000000001386.
PubMed 30157131Margolis JM, Juneau P, Sadosky A, Cappelleri JC, Bryce TN, Nieshoff EC. Health care resource utilization and medical costs of spinal cord injury with neuropathic pain in a commercially insured population in the United States. Arch Phys Med Rehabil. 2014 Dec;95(12):2279-87. doi: 10.1016/j.apmr.2014.07.416. Epub 2014 Aug 24.
PubMed 25159715Serpell M, Ratcliffe S, Hovorka J, Schofield M, Taylor L, Lauder H, Ehler E. A double-blind, randomized, placebo-controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment. Eur J Pain. 2014 Aug;18(7):999-1012. doi: 10.1002/j.1532-2149.2013.00445.x. Epub 2014 Jan 13.
PubMed 24420962Siddall PJ, Cousins MJ, Otte A, Griesing T, Chambers R, Murphy TK. Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial. Neurology. 2006 Nov 28;67(10):1792-800. doi: 10.1212/01.wnl.0000244422.45278.ff.
PubMed 17130411
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabinoids and an Anti-inflammatory Diet for the Treatment of Neuropathic Pain After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04057456
- Acronym / sponsor ID
- CATNP / 6465
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Keywords
- Nabilone, Spinal Cord Injury, Neuropathic pain, Pain, Anti Inflammatory Diet
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Eldon Loh, MDUniversity, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 side effects. Those with SCI have identified a need for additional treatment options, particularly those that are not medications. Nabilone and an anti-inflammatory diet are two treatments that may provide pain relief while being better tolerated. This study will evaluate the benefits of these treatments for neuropathic pain after SCI. Study participants will receive either an anti-inflammatory diet or a placebo diet, and nabilone or a placebo for 4 weeks. It is expected that an anti-inflammatory diet and nabilone will significantly decrease pain intensity and improve function. The combination of both treatments together is expected to have a greater effect than each alone.
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 following SCI that significantly decreases quality of life. Treatment options are limited, and current treatments can have significant side effects. Those with SCI have identified a need for additional treatment options, particularly those that are not medications. Cannabinoids and an anti-inflammatory diet may provide pain relief while being better tolerated.
The Co- Sponsor Investigators will test the potential benefits of these treatments for neuropathic pain after SCI.
Clinically, cannabinoids have been shown to be effective in the management of central NP after multiple sclerosis (MS), and although they have been trialed for a variety of complications after SCI, direct evidence for their ability to manage NP in this population is limited. Further, no studies have evaluated the efficacy of synthetic cannabinoids (nabilone) for the treatment of NP after SCI. Accordingly, the CanPainSCI Clinical Practice Guidelines concluded that the evidence is insufficient to develop a specific recommendation regarding cannabinoids in the treatment of NP after SCI. In addition, relevant side effects for those with SCI have not been well documented. Despite this, cannabinoids have been increasingly used as a treatment option for NP after SCI, particularly given increased access to, and greater societal acceptance of, cannabinoids in general. Studies that evaluate the effectiveness and side effects of cannabinoids and synthetic cannabinoids in the SCI population are therefore urgently needed.
An anti-inflammatory diet has recently shown promise in the management of NP after SCI. An RCT comparing an anti-inflammatory diet to placebo identified a reduction in sensory NP symptoms following SCI. This RCT was done in a general population of SCI patients and did not necessarily select those who were experiencing significant neuropathic pain. Therefore, additional evidence to demonstrate treatment effect will be important to justify widespread adoption of this diet for NP after SCI.
The study will collect data on a sample of up to 140 patients with SCI and at- and/or below-level neuropathic pain >3/10 in severity on the numeric rating scale.
The Principal Investigators will assess the treatment's effects on quality of life and pain management. If the study is successful, the results (and an evaluation of the process) will be used to inform an affordable and sustainable anti-inflammatory nutrition program to be implemented at Power Cord. This nutrition program will also be widely disseminated and potentially act as a template for similar programs In SCI care centres across Canada.
This study will assess blood samples at three time points for analysis of pro and anti-inflammatory markers. The research coordinator (blinded to the randomization) will assess patients using various quality of life and pain assessment questionnaires during clinic visits, at home or by telephone interview.
The type, level, and completeness of injury will be documented, and, if necessary, updated at each in-person visit. Each participant will be provided with instructions and study schedule. Protocol compliance will be tested through product count and interviews at each follow-up visit. Side effects will be assessed using standardized case report forms at each visit. Study visits may be in person or over the phone. Participants will be encouraged to report any events they may experience directly to the coordinator.
Participants who withdraw consent to continue treatments, will be encouraged to undergo the planned assessments. Withdrawal at the request of investigators or medical personnel may include, but are not limited to:
- Symptoms are deemed to be potentially related to the study product
- New diagnosis of exclusion criteria;
- Unacceptable side effects;
- Death
Estimated time to complete recruitment: Averaging 36 months, approximately 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Eligible participants who consent to study participation will be randomized to one of four groups: 1) Nabilone and Placebo Diet, 2) Placebo Capsule and Anti-inflammatory Diet, 3) Nabilone and Anti-inflammatory Diet, and 4) Placebo Capsule and Placebo Diet. Following randomization, participants will begin a study agent titration period (nabilone or placebo) in order to determine a safe and effective nabilone dose for each participant. Once the appropriate nabilone (or placebo) dosage for each participant is determined, participants will begin their respective interventions over the course of the 4-week treatment period. All outcome measures will be at assessed baseline, after the study agent titration period, and post-testing (following the 4-week treatment period).
| Arm | Type | Receives |
|---|---|---|
| Placebo diet and placebo capsules | Placebo comparator | Other: Placebo diet, Other: Placebo capsulesParticipants taking the placebo diet and capsules |
| Placebo diet and Nabilone capsules | Active comparator | Other: Placebo diet, Drug: Nabilone CapsulesCapsules will be 0.5mg nabilone. Participants will take up to 8 capsules per day for a maximum dose of 4mg of nabilone per day. |
| Anti-inflammatory diet and placebo capsules | Active comparator | Other: Anti-inflammatory diet, Other: Placebo capsulesThis meal plan will eliminate foods that have been established as pro-inflammatory (e.g. processed foods, refined sugars, refined wheat products, etc.) as well as foods that are commonly associated with even mild intolerances (e.g. cow's milk) and those that negatively impact cardiovascular health (e.g. hydrogenated oils, alcohol, coffee, refined sugars and wheat, trans fats, processed foods). In their place, the meal plan will consist of foods with established anti-inflammatory properties (e.g. (Oily fish, lean poultry, dark leafy greens, cruciferous vegetables, nuts, whole grains, most kinds of berries, etc). |
| Anti-inflammatory diet and Nabilone capsules | Active comparator | Other: Anti-inflammatory diet, Drug: Nabilone CapsulesCapsules will be 0.5mg nabilone. Participants will take up to 8 capsules per day for a maximum dose of 4mg of nabilone per day. This meal plan will eliminate foods that have been established as pro-inflammatory (e.g. processed foods, refined sugars, refined wheat products, etc.) as well as foods that are commonly associated with even mild intolerances (e.g. cow's milk) and those that negatively impact cardiovascular health (e.g. hydrogenated oils, alcohol, coffee, refined sugars and wheat, trans fats, processed foods). In their place, the meal plan will consist of foods with established anti-inflammatory properties (e.g. (Oily fish, lean poultry, dark leafy greens, cruciferous vegetables, nuts, whole grains, most kinds of berries, etc). |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo dietThe dietitian will assist in developing a diet that is isocaloric to the anti-inflammatory diet and healthy (for the sake of the participants' well-being, and to blind participants), while allowing many foods that are (counterintuitively) pro-inflammatory (e.g. whole wheat bread, white beans, oats, soy, eggplant, raspberries, pumpkin seeds, popcorn, etc). Occasional "cheat" foods are built into the placebo diet but with more pro-inflammatory options (e.g. two glasses of wine per week). | Other | Placebo diet and Nabilone capsules, Placebo diet and placebo capsules |
| Anti-inflammatory dietParticipants will also be given a list of foods that they are allowed on the anti-inflammatory diet, and a list of foods to avoid so that they can make informed substitutions to the meals and ingredients that they are given. The study participants will be given a one-week meal plan with accompanying recipes. Occasional "cheat" foods are built into the anti-inflammatory diet (e.g. two bottles of beer per week) | Other | Anti-inflammatory diet and Nabilone capsules, Anti-inflammatory diet and placebo capsules |
| Nabilone CapsulesCapsules will be 0.5mg nabilone. Participants will undergo a 5-week titration period by taking 1 (0.5mg) nabilone capsule per day for a three-day period. The dose will be increased on a fixed schedule by 1 (0.5mg) capsule every three days to a maximum of 8 capsules/day (4mg). Dosage will be maintained if higher doses are not tolerated or if sufficient relief is obtained (at least a 2-point change on the NRS). Once the appropriate nabilone (or placebo) dosage for each participant is determined, participants will begin their respective interventions over the course of the 4-week treatment period. | Drug | Anti-inflammatory diet and Nabilone capsules, Placebo diet and Nabilone capsules |
| Placebo capsulesPlacebo capsules contain no active ingredient. Participants on placebo capsules will undergo the same 5-week titration period and intervention period as those on active treatment. | Other | Anti-inflammatory diet and placebo capsules, Placebo diet and placebo capsules |
Primary outcome
Average pain intensity
Time frame: Baseline and 9 weeks
Change from baseline to end of study in average pain intensity evaluated using the Numeric Rating Scale, which measures pain using a scale of 1-10 (1 being mild, and 10 being severe)
Sensory changes
Time frame: Baseline and 9 weeks
Changes from baseline to end of study in the items on the Neuropathic Pain Questionnaire
Pain relief
Time frame: Baseline and 9 weeks
Proportion of participants achieving at least 30% and 50% pain relief between treatments.
8 secondary outcomes
Patient global impression of change
Time frame: Baseline and 9 weeks
Financial feasibility of following anti-inflammatory diet
Time frame: 9 weeks
Mood Centre for Epidemiologic Studies-Depression scale
Time frame: Baseline and 9 weeks
Sleep
Time frame: Baseline and 9 weeks
Spasticity
Time frame: Baseline and 9 weeks
Pro-Inflammatory biomarkers
Time frame: Baseline and 9 weeks
Profile of Mood States
Time frame: Baseline and 9 weeks
Anti-Inflammatory Biomarkers
Time frame: Baseline and 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Background: PubMed 27444714Loh E, Guy SD, Mehta S, Moulin DE, Bryce TN, Middleton JW, Siddall PJ, Hitzig SL, Widerstrom-Noga E, Finnerup NB, Kras-Dupuis A, Casalino A, Craven BC, Lau B, Cote I, Harvey D, O'Connell C, Orenczuk S, Parrent AG, Potter P, Short C, Teasell R, Townson A, Truchon C, Bradbury CL, Wolfe D. The CanPain SCI Clinical Practice Guidelines for Rehabilitation Management of Neuropathic Pain after Spinal Cord: introduction, methodology and recommendation overview. Spinal Cord. 2016 Aug;54 Suppl 1:S1-6. doi: 10.1038/sc.2016.88.
- Background: PubMed 27444715Guy SD, Mehta S, Casalino A, Cote I, Kras-Dupuis A, Moulin DE, Parrent AG, Potter P, Short C, Teasell R, Bradbury CL, Bryce TN, Craven BC, Finnerup NB, Harvey D, Hitzig SL, Lau B, Middleton JW, O'Connell C, Orenczuk S, Siddall PJ, Townson A, Truchon C, Widerstrom-Noga E, Wolfe D, Loh E. The CanPain SCI Clinical Practice Guidelines for Rehabilitation Management of Neuropathic Pain after Spinal Cord: Recommendations for treatment. Spinal Cord. 2016 Aug;54 Suppl 1:S14-23. doi: 10.1038/sc.2016.90.
- Background: PubMed 27316678Allison DJ, Thomas A, Beaudry K, Ditor DS. Targeting inflammation as a treatment modality for neuropathic pain in spinal cord injury: a randomized clinical trial. J Neuroinflammation. 2016 Jun 17;13(1):152. doi: 10.1186/s12974-016-0625-4.
- Background: PubMed 25160710Fine PG, Rosenfeld MJ. Cannabinoids for neuropathic pain. Curr Pain Headache Rep. 2014 Oct;18(10):451. doi: 10.1007/s11916-014-0451-2.
- Background: PubMed 29442178Nielsen S, Germanos R, Weier M, Pollard J, Degenhardt L, Hall W, Buckley N, Farrell M. The Use of Cannabis and Cannabinoids in Treating Symptoms of Multiple Sclerosis: a Systematic Review of Reviews. Curr Neurol Neurosci Rep. 2018 Feb 13;18(2):8. doi: 10.1007/s11910-018-0814-x.
- Background: PubMed 26398734Eisenstein M. Medical marijuana: Showdown at the cannabis corral. Nature. 2015 Sep 24;525(7570):S15-7. doi: 10.1038/525S15a. No abstract available.
- Background: PubMed 23180178Langford RM, Mares J, Novotna A, Vachova M, Novakova I, Notcutt W, Ratcliffe S. A double-blind, randomized, placebo-controlled, parallel-group study of THC/CBD oromucosal spray in combination with the existing treatment regimen, in the relief of central neuropathic pain in patients with multiple sclerosis. J Neurol. 2013 Apr;260(4):984-97. doi: 10.1007/s00415-012-6739-4. Epub 2012 Nov 21.
- Background: PubMed 29513392Mucke M, Phillips T, Radbruch L, Petzke F, Hauser W. Cannabis-based medicines for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2018 Mar 7;3(3):CD012182. doi: 10.1002/14651858.CD012182.pub2.
- Background: PubMed 19362699Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.
- Background: PubMed 29192670Ware MA. Medical Cannabis Research: Issues and Priorities. Neuropsychopharmacology. 2018 Jan;43(1):214-215. doi: 10.1038/npp.2017.222. No abstract available.
- Background: PubMed 21289620Karschner EL, Darwin WD, McMahon RP, Liu F, Wright S, Goodwin RS, Huestis MA. Subjective and physiological effects after controlled Sativex and oral THC administration. Clin Pharmacol Ther. 2011 Mar;89(3):400-7. doi: 10.1038/clpt.2010.318. Epub 2011 Feb 2.
- Background: PubMed 30157131De Gregorio D, McLaughlin RJ, Posa L, Ochoa-Sanchez R, Enns J, Lopez-Canul M, Aboud M, Maione S, Comai S, Gobbi G. Cannabidiol modulates serotonergic transmission and reverses both allodynia and anxiety-like behavior in a model of neuropathic pain. Pain. 2019 Jan;160(1):136-150. doi: 10.1097/j.pain.0000000000001386.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eldon Loh, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
David Ditor, MD principal investigator
Brock University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anti-inflammatory diet and Nabilone Capsules in people with Spinal Cord Injuries and Neuropathic Pain, run by Eldon Loh, MD at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average pain intensity (time frame: Baseline and 9 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04057456, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.