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Cannabinoids + Anti-inflammatory Diet for Neuropathic Pain (CATNP Trial)
Phase 3
Recruiting
Led By David Ditor, MD
Research Sponsored by Eldon Loh, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 25 and over, based on year of birth
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 weeks
Awards & highlights
CATNP Trial Summary
This trialwill look at if an anti-inflammatory diet and nabilone can help reduce neuropathic pain in people with spinal cord injury.
Who is the study for?
Adults over 25 with a stable spinal cord injury for at least a year, experiencing neuropathic pain. They must not be pregnant or planning pregnancy, have used cannabinoids recently, or have certain medical conditions like liver issues or psychotic disorders. Stable dosing of other pain meds is required and they must agree to use birth control.Check my eligibility
What is being tested?
The trial tests if an anti-inflammatory diet and Nabilone capsules can reduce neuropathic pain in those with spinal cord injuries better than placebo alternatives. Participants will follow the assigned diet and take either Nabilone or placebo capsules for four weeks.See study design
What are the potential side effects?
Potential side effects may include typical reactions to cannabinoids such as dizziness, dry mouth, fatigue, and mood changes. The anti-inflammatory diet is generally well-tolerated but could cause changes in bowel habits.
CATNP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 25 years old or older.
Select...
I have chronic pain from a nerve injury that scores more than 3 out of 10.
Select...
I have had constant pain for 3 months or pain that comes and goes for 6 months.
CATNP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average pain intensity
Pain relief
Sensory changes
Secondary outcome measures
Anti-Inflammatory Biomarkers
Financial feasibility of following anti-inflammatory diet
Mental Depression
+5 moreCATNP Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: Anti-inflammatory diet and Nabilone capsulesActive Control2 Interventions
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).
Group II: Placebo diet and Nabilone capsulesActive Control2 Interventions
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.
Group III: Anti-inflammatory diet and placebo capsulesActive Control2 Interventions
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).
Group IV: Placebo diet and placebo capsulesPlacebo Group2 Interventions
Participants taking the placebo diet and capsules
Find a Location
Who is running the clinical trial?
Eldon Loh, MDLead Sponsor
Ontario Neurotrauma FoundationOTHER
22 Previous Clinical Trials
963 Total Patients Enrolled
1 Trials studying Neuropathic Pain
20 Patients Enrolled for Neuropathic Pain
David Ditor, MDPrincipal InvestigatorBrock University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver function tests are significantly abnormal.I have had a spinal cord injury for over a year, with no worsening in the last 6 months.I am not pregnant, breastfeeding, nor planning to become pregnant during the study and for three months after.I have conditions that could affect the assessment of my nerve pain after a spinal cord injury.You must have a body mass index (BMI) between 18 and 40.I am 25 years old or older.You have a history of a serious mental illness called a psychotic disorder.You cannot tolerate cannabinoids.I have chronic pain from a nerve injury that scores more than 3 out of 10.I have not used any cannabinoid medications for at least 1 month.My pain medication doses have been the same for the last month.You have a history of using drugs or alcohol in a way that caused problems.I am currently using cannabinoids or cannabinoid medication.I am currently having thoughts about harming myself.I have a history of seizures.I am using birth control and have a negative pregnancy test.I have had constant pain for 3 months or pain that comes and goes for 6 months.I am using or willing to use effective birth control during and for three months after the study.I do not have any other major health issues that could affect my study participation.My doctor thinks I can safely participate in the study despite my health issues.I have a spinal cord injury on top of a pre-existing narrow spinal canal.I have not had a heart attack or major heart issues in the past year.I have a spinal cord condition not caused by cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Anti-inflammatory diet and Nabilone capsules
- Group 2: Placebo diet and placebo capsules
- Group 3: Placebo diet and Nabilone capsules
- Group 4: Anti-inflammatory diet and placebo capsules
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have the FDA certified Anti-inflammatory diet and Nabilone capsules for therapeutic use?
"Our team at Power rated the safety of Anti-inflammatory diet and Nabilone capsules a 3 due to sufficient data confirming its efficacy as well as numerous studies backing up its security."
Answered by AI
Are researchers still recruiting participants for this experiment?
"Per the clinicaltrials.gov portal, this medical trial is currently soliciting participants. The study was initially posted on December 22nd 2022 and underwent its last update on the same date."
Answered by AI
Are there any comparable studies which demonstrate the efficacy of an Anti-inflammatory diet in combination with Nabilone capsules?
"At the current moment, there are 5 experiments assessing Anti-inflammatory diet and Nabilone capsules. Of those trials 3 have reached Phase 3 of clinical testing. These studies, which were initially based in New york City, now span 9 different medical centres across the USA."
Answered by AI
What is the quota for participants in this experiment?
"Affirmative. Per the information on clinicaltrials.gov, this medical experiment is actively recruiting participants for enrollment and began posting to the site on December 22nd 2022. As of now, 140 patients need to be recruited from a single location."
Answered by AI
What is the expected outcome of this research endeavor?
"This clinical trial, which will span from Baseline to 9 weeks, is geared towards reducing pain levels with secondary goals of decreasing spasticity as measured by the SCI-Spasticity Evaluation Tool (SCI-SET), improving sleep quality through Leeds Sleep Evaluation Questionnaire results, and assessing overall patient satisfaction via a Patient Global Impression of Change questionnaire."
Answered by AI
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