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Cannabinoids + Anti-inflammatory Diet for Neuropathic Pain (CATNP Trial)
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.
CATNP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCATNP Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CATNP Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Placebo diet and placebo capsules
- Group 2: Anti-inflammatory diet and Nabilone capsules
- Group 3: Placebo diet and Nabilone capsules
- Group 4: Anti-inflammatory diet and placebo capsules
- 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.
- 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
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."
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."
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."
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."
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."
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