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

NCT05630235 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 20220782
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

SCI - Spinal Cord Injury; Neuropathic Pain

Outcome Measures

Primary Outcomes (2)

• 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, approximately 3 hours post intervention, and approximately 6 hours post intervention

• Change in brain electrocortical activity at rest.

  Assess brain electrocortical activity at rest using a 64-channel Biosemi EEG system and conducting EEG power spectrum analysis

  Baseline and 3 hours post intervention

Secondary Outcomes (4)

• Change in neuropathic pain symptoms severity using the NPSI.

  Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention

• Change in sensory function using QST.

  Baseline and 3 hours post intervention

• Change in state anxiety using the STAI.

  Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention

• Subjective Drug Effects

  Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention

Study Arms (2)

CBD/CBD-A followed by placebo group

EXPERIMENTAL

Participants in this group will receive a one time dose of CBD/CBD-A on visit 2, followed by a placebo on visit 3 after a two-week period.

Drug: CBD/CBD-A; Other: Placebo

Placebo followed by CBD/CBD-A group

EXPERIMENTAL

Participants in this group will receive a placebo on visit 2, followed by a one time of CBD/CBD-A on visit 3 after a two-week period.

Drug: CBD/CBD-A; Other: Placebo

Interventions

CBD/CBD-A DRUG

Participants will be administered a one-time dose of 204.6 mg of CBD/CBD-A orally.

CBD/CBD-A followed by placebo group; Placebo followed by CBD/CBD-A group

Placebo OTHER

The placebo equivalent of the CBD/CBD-A dose administered orally.

CBD/CBD-A followed by placebo group; Placebo followed by CBD/CBD-A group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men or Women;
• years of age with an incomplete or complete acquired traumatic SCI;
• 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);
• 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).
• Must have previous experience with consuming cannabis and or cannabinoids.

You may not qualify if:

• Current drug (DAST-10: \>6) or alcohol abuse (AUDIT: \>10);
• Current use of cannabis plant or cannabis products (CBD or CBD+THC) or any other drugs of abuse (unless prescribed) including alcohol;
• Presence of significant medical illness (e.g., diabetes, obesity, cardiovascular disease, hypertension, hepatitis) or other significant neurological trauma;
• 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;
• 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;
• 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;
• Have a history of renal or hepatic disease: or
• Have elevated serum creatinine above the laboratory upper limit of normal (ULN): or
• Have elevated serum transaminases (ALT or AST) above the ULN: or
• Have elevated total bilirubin above the ULN; or
• Take valproate, due increased risk of liver enzyme elevation; or
• Currently using strong CYP2C19 and CYP3A4 inducers; or
• Have suicidal ideation (subjects should be screened for suicidal ideation); or
• Cannot abstain from the use of alcohol during the study period, due to increased risk of sedation; or
• Have a known or suspected hypersensitivity to cannabidiol or tetrahydrocannabinol.

Sponsors & Collaborators

• University of Miami: lead
• Consortium for Medical Marijuana Clinical Outcomes Research: collaborator

Study Sites (1)

Lynn Rehabilitation Center

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eva Widerstrom-Noga, PhD, DDS

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Widerstrom-Noga, PhD, DDS

CONTACT

+1 (305) 2437125; ewiderstrom-noga@med.miami.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: November 29, 2022
• Study Start: June 16, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)