Effects of Cannabidiol (CBD) on Resting-state Electroencephalography (EEG) and Neuropathic Pain Severity in People With Spinal Cord Injury (SCI)

Study Overview
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Brief Summary
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The main purposes of this study are to (1) measure the effect of CBD on pain symptoms, pain intensity, pain unpleasantness, and skin sensitivity to hot and cold temperature; and (2) measure the effect of CBD on brain electrical activity with electroencephalography (EEG).

Official Title
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Effects of Cannabidiol (CBD) on Resting-state Electroencephalography (EEG) and Neuropathic Pain Severity in People With Spinal Cord Injury (SCI)

Conditions
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SCI - Spinal Cord Injury, Neuropathic Pain

Intervention / Treatment
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* Drug: CBD
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women 18-64 years of age with an incomplete or complete traumatic SCI. Must have experienced continuous neuropathic pain for a minimum of three months prior to entering the study. Neuropathic pain will be assessed and classified using the International Spinal Cord Injury Basic Pain Dataset (ISCIBPD), the Neuropathic Pain Symptom Inventory, the International SCI pain classification, and the Douleur Neuropathique (DN-4) Questionnaire. The pain intensity must be in the moderate to severe category, which will be defined as a score of at least four on a numerical rating scale (NRS) (range of 0 to 10). Exclusion Criteria: Current drug or alcohol abuse. Presence of significant medical illness (e.g., diabetes, obesity, cardiovascular disease, hypertension, hepatitis) or other significant neurological trauma. Current severe psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia, post-traumatic stress disorder). Adults who are unable to consent, women who are pregnant, breastfeeding, or not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD), and prisoners. Pregnancy will be evaluated using a pregnancy test during the screening session. Women had to be on birth control for a minimum of 3 months before participating in the study, and can stop birth control after 1 month.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBD followed by placebo group<br>Participants in this group will receive CBD on day one followed by placebo within a two week follow-up visit. | Drug: CBD<br>* Participants will be administered a one time dose of 250mg of CBD orally.<br>Other: Placebo<br>* The placebo equivalent of the CBD oil administered orally.<br>|
| Experimental: Placebo followed by CBD group<br>Participants in this group will receive placebo on day one followed by CBD within a two week follow-up visit. | Drug: CBD<br>* Participants will be administered a one time dose of 250mg of CBD orally.<br>Other: Placebo<br>* The placebo equivalent of the CBD oil administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neuropathic pain intensity or unpleasantness. | Assess changes in pain intensity and unpleasantness of the worst neuropathic pain using a numerical rating scale from 0-10 (0 no pain and 10 worst imaginable/unpleasant pain). | Baseline and 3 hours post intervention | 
| Change in brain activity at rest. | Assess brain activity using a 64-channel Biosemi EEG system. | Baseline and 3 hours post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neuropathic pain symptoms severity using the NPSI. | The Neuropathic Pain Symptom Inventory (NPSI) will assess the presence and severity of common neuropathic pain symptoms. Range 0-100 with higher scores representing greater neuropathic pain symptoms. | Baseline and 3 hours post intervention | 
| Change in sensory function using QST. | Sensory function will be assessed using quantitative sensory testing (QST) using an FDA-approved Thermal Sensory Analyzer. | Baseline and 3 hours post intervention | 
| Change in state anxiety using the STAI. | Using the State-trait Anxiety Inventory (STAI), we will evaluate changes in momentary anxiety with scores ranging from 5-20. Higher values equate to greater anxiety symptoms. | Baseline and 3 hours post intervention |