Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 57 for:    Recruiting, Not yet recruiting, Available Studies | NOT (Use Disorders OR Marijuana Use OR Dependence OR Abuse OR Drug Use) | cannabinoids

Cannabinoids and an Anti-inflammatory Diet for the Treatment of Neuropathic Pain After Spinal Cord Injury (CATNP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04057456
Recruitment Status : Not yet recruiting
First Posted : August 15, 2019
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
Ontario Neurotrauma Foundation
Information provided by (Responsible Party):
Eldon Loh, Lawson Health Research Institute

Brief Summary:
This study evaluates the combination of a CBD or THC/CBD capsule and an anti-inflammatory diet in the treatment of neuropathic pain in spinal cord injuries. In the first part of the study participants will receive either a THC/CBD Capsule with placebo diet, a CBD capsule with placebo diet, a placebo capsule with an anti-inflammatory diet, or a placebo capsule and diet. In the second part participants will either receive a placebo capsule and placebo diet, an anti-inflammatory diet and THC/CBD capsule, or an anti-inflammatory diet and high CBD capsule.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Neuropathic Pain Other: Placebo diet Other: Anti-inflammatory diet Drug: TCH/CBD Capsules Drug: High CBD Capsules Other: Placebo capsules Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Eligible participants who consent to study participation will be randomized to one of four groups: THC/CBD group (THC/CBD capsule (1:1) + placebo diet); CBD group (high CBD capsule (1:20)); anti-inflammatory diet group (anti-inflammatory diet + placebo capsule); or placebo group (placebo capsule +placebo diet). Those on the anti-inflammatory diet will be given a meal plan and recipes. Cannabinoid (THC/CBD and high CBD capsules) and anti-inflammatory diet groups will transition to a combined active treatment protocol, while the control group will remain as is. Those in the original cannabinoid groups (THC/CBD or high CBD capsules) will switch from the placebo diet to the anti-inflammatory diet. Those in the original anti-inflammatory diet group will be randomized from placebo capsules to either CBD only or THC/CBD capsules. The original diet group will take capsules with CBD alone in order to evaluate the efficacy of CBD compared to the combination of THC and CBD.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: No other parties will be masked for the study.
Primary Purpose: Treatment
Official Title: Cannabinoids and an Anti-inflammatory Diet for the Treatment of Neuropathic Pain After Spinal Cord Injury
Estimated Study Start Date : October 15, 2019
Estimated Primary Completion Date : January 15, 2022
Estimated Study Completion Date : January 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo diet and placebo capsules
Participants taking the placebo diet and capsules
Other: Placebo diet
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).

Other: Placebo capsules
no active ingredient capsule

Active Comparator: Placebo diet and THC/CBD capsules
Capsules will be 1:1 (2.5 mg:2.5 mg)
Other: Placebo diet
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).

Drug: TCH/CBD Capsules
See arms description

Active Comparator: Placebo diet and high CBD Capsules
Capsules will be 1:20 (1mg:20mg)
Other: Placebo diet
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).

Drug: High CBD Capsules
See arms description

Active Comparator: Anti-inflammatory diet and placebo capsules
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).
Other: Anti-inflammatory diet
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)

Other: Placebo capsules
no active ingredient capsule

Active Comparator: Anti-inflammatory diet and THC/CBD capsules
capsules will be 1:1 (2.5mg:2.5mg)
Other: Anti-inflammatory diet
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)

Drug: TCH/CBD Capsules
See arms description

Active Comparator: Anti-inflammatory diet and High CBD capsules
Capsules will be 1:20 (1mg:20mg)
Other: Anti-inflammatory diet
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)

Drug: High CBD Capsules
See arms description




Primary Outcome Measures :
  1. Average pain intensity [ Time Frame: 12 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)

  2. Sensory changes [ Time Frame: 12 weeks ]
    Changes from baseline to end of study in the items on the Neuropathic Pain Questionnaire

  3. Pain relief [ Time Frame: 12 weeks ]
    Proportion of participants achieving at least 30% and 50% pain relief between treatments.


Secondary Outcome Measures :
  1. Patient global impression of change [ Time Frame: 12 weeks ]
    change from first study visit to end of study in the Patient global impression of change questionnaire

  2. Work productivity and activity [ Time Frame: 12 weeks ]
    Change from baseline to end of study in the • Work Productivity and Activity Questionnaire: Specific Health Impairment Version 2

  3. Mood Centre for Epidemiologic Studies-Depression scale [ Time Frame: 12 weeks ]
    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.

  4. Sleep [ Time Frame: 12 weeks ]
    Changes from baseline to end of study in sleep assessed by Leeds Sleep Evaluation Questionnaire

  5. Spasticity [ Time Frame: 12 weeks ]
    Changes from baseline to end of study in spasticity documented using the SCI-Spasticity Evaluation Tool (SCI-SET)

  6. Pro-Inflammatory biomarkers [ Time Frame: 12 weeks ]
    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.

  7. Profile of Mood States [ Time Frame: 12 weeks ]
    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.

  8. Anti-Inflammatory Biomarkers [ Time Frame: 12 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent obtained prior to any study-related activities
  2. A spinal cord injury at least 12 months duration
  3. 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) Patients 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.
  4. Ongoing constant pain for at least 3 months, or relapsing/remitting pain for at least 6 months.
  5. 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.
  6. Any cannabinoids, or cannabinoid medications (e.g. nabilone) will need to be stopped at least 7 days prior to screening for and inclusion in the study

Exclusion Criteria:

  1. History of psychotic disorder
  2. History of convulsive disorders
  3. History of substance abuse
  4. Pregnancy
  5. Current suicidal ideation
  6. Intolerance to cannabinoids
  7. Traumatic SCI superimposed on prior congenital stenosis
  8. Those unwilling to stop PRN medications for pain during the study
  9. Presence of other medical conditions that confound the assessment of neuropathic pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057456


Contacts
Layout table for location contacts
Contact: Eldon Loh, MD 519-685-4080 Eldon.loh@sjhc.london.on.ca
Contact: Alexandria Roa Agudelo 519 646-6100 ext 42696 Alexandria.RoaAgudelo@sjhc.london.on.ca

Sponsors and Collaborators
Eldon Loh
Ontario Neurotrauma Foundation
Investigators
Layout table for investigator information
Principal Investigator: Eldon Loh, MD Lawson Health Research Institute
Principal Investigator: David Ditor, MD Brock University

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Eldon Loh, Physician, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04057456     History of Changes
Other Study ID Numbers: 6465
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Neuralgia
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents