Effects of CBD/CBD-A Oral Extract on Resting-state EEG and Neuropathic Pain Symptoms After SCI

Effects of a Hemp-derived Cannabidiol and Cannabidiolic-acid Oral Extract on Resting-state Electroencephalography and Neuropathic Pain Symptoms in People With Spinal Cord Injury

The main purposes of this study are to (1) measure the effect of CBD/CBD-A on pain symptoms, pain intensity, pain unpleasantness, and skin sensitivity to hot and cold temperatures; and (2) measure the effect of CBD on brain electrical activity with electroencephalography (EEG).

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain; SCI - Spinal Cord Injury
• Intervention / Treatment: Other: Placebo; Drug: CBD/CBD-A

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Lynn Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Men or Women;
2. 18-64 years of age with an incomplete or complete acquired traumatic SCI;
3. Must have experienced neuropathic pain for a minimum of three months before entering the study (neuropathic pain will be assessed using the International SCI Pain Classification);
4. The pain intensity must be in the moderate to severe category, which will be defined as a score of at least four on an NRS (range of 0 to 10).
5. Must have previous experience with consuming cannabis and or cannabinoids.

Exclusion Criteria:

1. Current drug (DAST-10: >6) or alcohol abuse (AUDIT: >10);
2. Current use of cannabis plant or cannabis products (CBD or CBD+THC) or any other drugs of abuse (unless prescribed) including alcohol;
3. Presence of significant medical illness (e.g., diabetes, obesity, cardiovascular disease, hypertension, hepatitis) or other significant neurological trauma;
4. History of or current severe psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia, post-traumatic stress disorder) judged by the investigator to put the subject at greater risk of experiencing an adverse event;
5. 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;
6. Current pregnancy. Pregnancy will be evaluated using a pregnancy test during the first study visit. Female subjects of childbearing potential will be required to use two forms of effective birth control for the 3 months prior to participating in the study and continuing for 1 month after completion of the study;
7. Have a history of renal or hepatic disease: or
8. Have elevated serum creatinine above the laboratory upper limit of normal (ULN): or
9. Have elevated serum transaminases (ALT or AST) above the ULN: or
10. Have elevated total bilirubin above the ULN; or
11. Take valproate, due increased risk of liver enzyme elevation; or
12. Currently using strong CYP2C19 and CYP3A4 inducers; or
13. Have suicidal ideation (subjects should be screened for suicidal ideation); or
14. Cannot abstain from the use of alcohol during the study period, due to increased risk of sedation; or
15. Have a known or suspected hypersensitivity to cannabidiol or tetrahydrocannabinol.
16. Have a known or suspected hypersensitivity to sesame seed oil, lecithin, or bovine gelatin.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBD/CBD-A followed by placebo group; Participants in this group will receive a one time dose of CBD/CBD-A on visit 2, followed by a placebo on visit 3 after a two-week period.	Other: Placebo; The placebo equivalent of the CBD/CBD-A dose administered orally.; Drug: CBD/CBD-A; Participants will be administered a one-time dose of 204.6 mg of CBD/CBD-A orally.
Experimental: Placebo followed by CBD/CBD-A group; Participants in this group will receive a placebo on visit 2, followed by a one time of CBD/CBD-A on visit 3 after a two-week period.	Other: Placebo; The placebo equivalent of the CBD/CBD-A dose administered orally.; Drug: CBD/CBD-A; Participants will be administered a one-time dose of 204.6 mg of CBD/CBD-A orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in brain electrocortical activity at rest.	Assess brain electrocortical activity at rest using a 64-channel Biosemi EEG system and conducting EEG power spectrum analysis	Baseline and 3 hours post intervention
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, approximately 3 hours post intervention, and approximately 6 hours post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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, approximately 3 hours post intervention, and approximately 6 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, approximately 3 hours post intervention, and approximately 6 hours post intervention
Subjective Drug Effects	Drug Effects Questionnaire (DEQ): The DEQ is a brief five item instrument used to assess subjective drug effects. The five items are presented on a 100 mm visual analogue scale ranging from not at all to extremely. The participants are instructed to draw a vertical line at any place between the two responses	Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Consortium for Medical Marijuana Clinical Outcomes Research
• Investigators: Principal Investigator: Eva Widerstrom-Noga, PhD, DDS, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2025
• Primary Completion (Actual): August 13, 2026
• Study Completion (Actual): August 13, 2026

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2026
• Last Update Submitted That Met QC Criteria: August 13, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neuralgia; Spinal Cord Injuries
• Other Study ID Numbers: 20220782

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No