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

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 enteringthe study (neuropathic pain will be assessed using the International SCI PainClassification);

4. The pain intensity must be in the moderate to severe category, which will be definedas 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 otherdrugs of abuse (unless prescribed) including alcohol;

3. Presence of significant medical illness (e.g., diabetes, obesity, cardiovasculardisease, 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 theinvestigator 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 notpracticing an effective form of birth control (condoms, diaphragm, birth controlpill, IUD), and prisoners;

6. Current pregnancy. Pregnancy will be evaluated using a pregnancy test during thefirst study visit. Female subjects of childbearing potential will be required to usetwo forms of effective birth control for the 3 months prior to participating in thestudy 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 increasedrisk 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 bovinegelatin.