Effects of Cannabidiol (CBD) on Resting-state Electroencephalography (EEG) and Neuropathic Pain Severity in People With Spinal Cord Injury (SCI)

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purposes of this study are to (1) measure the effect of CBD on pain symptoms, pain intensity, pain unpleasantness, and skin sensitivity to hot and cold temperature; and (2) measure the effect of CBD on brain electrical activity with electroencephalography (EEG).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Collaborator: Consortium for Medical Marijuana Clinical Outcomes Research

Criteria

Inclusion Criteria:

1. Men or women

2. 18-64 years of age with an incomplete or complete traumatic SCI.

3. Must have experienced continuous neuropathic pain for a minimum of three months prior to entering the study. Neuropathic pain will be assessed and classified using the International Spinal Cord Injury Basic Pain Dataset (ISCIBPD), the Neuropathic Pain Symptom Inventory, the International SCI pain classification, and the Douleur Neuropathique (DN-4) Questionnaire.

4. The pain intensity must be in the moderate to severe category, which will be defined as a score of at least four on a numerical rating scale (NRS) (range of 0 to 10).

Exclusion Criteria:

1. Current drug or alcohol abuse.

2. Presence of significant medical illness (e.g., diabetes, obesity, cardiovascular disease, hypertension, hepatitis) or other significant neurological trauma.

3. Current severe psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia, post-traumatic stress disorder).

4. 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. Pregnancy will be evaluated using a pregnancy test during the screening session. Women had to be on birth control for a minimum of 3 months before participating in the study, and can stop birth control after 1 month.