Effects of CBD on pain and brain activity after spinal cord injury

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

This study is testing whether CBD can help people with spinal cord injuries feel less pain and improve brain activity compared to a placebo.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: University of Miami (Academic / other)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT05630235 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of CBD and CBD-A oral extracts on neuropathic pain symptoms and brain electrical activity in individuals with spinal cord injuries. Participants will be assessed for pain intensity, unpleasantness, and sensitivity to temperature, alongside monitoring changes in resting-state EEG patterns. The study includes both a treatment group receiving CBD/CBD-A and a placebo group to evaluate the efficacy of the intervention. It aims to provide insights into the therapeutic potential of cannabinoids for managing pain and neurological function post-injury.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-64 with a traumatic spinal cord injury and moderate to severe neuropathic pain lasting at least three months.

Not a fit: Patients with current substance abuse issues or significant medical or psychiatric conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a novel treatment option for managing neuropathic pain in spinal cord injury patients.

How similar studies have performed: Previous studies have shown promising results with cannabinoids for pain management, suggesting potential success for this approach.

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.

Where this trial is running

Miami, Florida

• Lynn Rehabilitation Center — Miami, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Eva Widerstrom-Noga, PhD, DDS — University of Miami
• Study coordinator: Eva Widerstrom-Noga, PhD, DDS

Conditions SCI - Spinal Cord Injury; Neuropathic Pain