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Effects of CBD/CBD-A Oral Extract on Resting-state EEG and Neuropathic Pain Symptoms After SCI | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT05630235•University of Miami

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

Locations (1)

Lynn Rehabilitation Center

Miami, Florida, United States

Key Dates

Start Date

June 16, 2025

Primary Completion Date

June 30, 2026

Completion Date

June 30, 2026

Last Updated

June 17, 2025

Enrollment

ESTIMATED participants

Conditions

SCI - Spinal Cord InjuryNeuropathic Pain

Interventions

CBD/CBD-A

DRUG

Placebo

OTHER

Contacts

Eva Widerstrom-Noga, PhD, DDS

CONTACT

+1 (305) 2437125 ewiderstrom-noga@med.miami.edu

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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