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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.

Must not have

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 patient who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 weeks

Awards & highlights

All Individual Drugs Already Approved

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 25 years old or older.

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I have chronic pain from a nerve injury that scores more than 3 out of 10.

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I have had constant pain for 3 months or pain that comes and goes for 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver function tests are significantly abnormal.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study and for three months after.

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I am currently using cannabinoids or cannabinoid medication.

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I am currently having thoughts about harming myself.

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I have a history of seizures.

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I have a spinal cord injury on top of a pre-existing narrow spinal canal.

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I have not had a heart attack or major heart issues in the past year.

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I have a spinal cord condition not caused by cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average pain intensity

Pain relief

Sensory changes

Secondary study objectives

Anti-Inflammatory Biomarkers

Financial feasibility of following anti-inflammatory diet

Mental Depression

+5 more

Awards & Highlights

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.

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

0 / 11Eligibility criteria met