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

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05630235
• Other study ID #: 20220782
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: University of Miami
• Contact: Nicholas P Cherup, PhD
• Phone: 305-243-4145
• Email: npc34[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Pain
• SCI - Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Drug:
• CBD
Participants will be administered a one time dose of 250mg of CBD orally.

Other:
• Placebo
The placebo equivalent of the CBD oil administered orally.

Locations

Country	Name	City	State
United States	Lynn Rehabilitation Center	Miami	Florida

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in neuropathic pain intensity or unpleasantness.	Assess changes in pain intensity and unpleasantness of the worst neuropathic pain using a numerical rating scale from 0-10 (0 no pain and 10 worst imaginable/unpleasant pain).	Baseline and 3 hours post intervention
Primary	Change in brain activity at rest.	Assess brain activity using a 64-channel Biosemi EEG system.	Baseline and 3 hours post intervention
Secondary	Change in neuropathic pain symptoms severity using the NPSI.	The Neuropathic Pain Symptom Inventory (NPSI) will assess the presence and severity of common neuropathic pain symptoms. Range 0-100 with higher scores representing greater neuropathic pain symptoms.	Baseline and 3 hours post intervention
Secondary	Change in sensory function using QST.	Sensory function will be assessed using quantitative sensory testing (QST) using an FDA-approved Thermal Sensory Analyzer.	Baseline and 3 hours post intervention
Secondary	Change in state anxiety using the STAI.	Using the State-trait Anxiety Inventory (STAI), we will evaluate changes in momentary anxiety with scores ranging from 5-20. Higher values equate to greater anxiety symptoms.	Baseline and 3 hours post intervention