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NCT05630235 | RECRUITING | SCI - Spinal Cord Injury

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

University of Miami

Information provided by (Responsible Party):

Eva Widerstrom-Noga

Brief 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).

Condition or disease

SCI - Spinal Cord Injury

Neuropathic Pain

Intervention/treatment

CBD/CBD-A

Placebo

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : DOUBLE
Primary Purpose : BASIC_SCIENCE
Official Title : 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
Actual Study Start Date : 2025-06-30
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 64 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Effects of CBD/CBD-A Oral Extract on Resting-state EEG and Neuropathic Pain Symptoms After SCI

Location Details

NCT05630235

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Lynn Rehabilitation Center

Miami, Florida, United States, 33136