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Active Not Recruiting NCT05630235

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

Conditions: SCI - Spinal Cord Injury, Neuropathic Pain

Sex: All
Ages: 18 Years – 64 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 6
Sponsor: University of Miami

Location: Lynn Rehabilitation Center Miami Florida

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 Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05630235). StuddyBuddy aggregates publicly available trial information.