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

Eligibility 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.
• 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.