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

Running, not enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: SCI - Spinal Cord Injury, Neuropathic Pain

In brief

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).

Key facts

Study ID: NCT05630235
Run by: University of Miami
People needed: 6
Starts: 2025-06-16
Expected to finish: 2026-09-30
Last updated by the study team: 2026-06-22

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Men or Women;
18-64 years of age with an incomplete or complete acquired traumatic SCI;
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);
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).
Must have previous experience with consuming cannabis and or cannabinoids.

You may not qualify if…

Current drug (DAST-10: >6) or alcohol abuse (AUDIT: >10);
Current use of cannabis plant or cannabis products (CBD or CBD+THC) or any other drugs of abuse (unless prescribed) including alcohol;
Presence of significant medical illness (e.g., diabetes, obesity, cardiovascular disease, hypertension, hepatitis) or other significant neurological trauma;
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;
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;
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;
Have a history of renal or hepatic disease: or
Have elevated serum creatinine above the laboratory upper limit of normal (ULN): or
Have elevated serum transaminases (ALT or AST) above the ULN: or
Have elevated total bilirubin above the ULN; or
Take valproate, due increased risk of liver enzyme elevation; or
Currently using strong CYP2C19 and CYP3A4 inducers; or
Have suicidal ideation (subjects should be screened for suicidal ideation); or
Cannot abstain from the use of alcohol during the study period, due to increased risk of sedation; or
Have a known or suspected hypersensitivity to cannabidiol or tetrahydrocannabinol.
Have a known or suspected hypersensitivity to sesame seed oil, lecithin, or bovine gelatin.

Where it is running

Lynn Rehabilitation Center — Miami, Florida, United States

Full record on ClinicalTrials.gov

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