Roberta Vastano, PhD
University of Miami
Co-Authors: Gabriel Fernandez1, Ian Frank Scott1, Meredith Pinkerton1, Timoth Simmons1, Alberto Martinez- Arizala1, Eva Widerstrom-Noga1
1University of Miami
Neuropathic pain (NP) is one of the most common consequences associated with spinal cord injury (SCI). Current treatments are not consistently effective. Analgesic, anti-inflammatory, and anti-epileptic effects of cannabidiol (CBD) have been demonstrated in multiple clinical populations, including SCI. In our recent survey study, respondents with SCI and NP reported that cannabis, including CBD and tetrahydrocannabinol (THC), reduced their pain and their use of opioids, gabapentin and over-the-counter pain medications. However, to date the effects of CBD on neuropathic pain intensity, anxiety and electroencephalography (EEG) in participants with SCI remain still poorly understood.
In this study (cross-over, double-blind, placebo-controlled phase I/II) we aim to: 1) compare changes in momentary pain intensity/unpleasantness of the worst NP and resting state EEG power between CBD/CBD-A and placebo administration; 2) explore changes in neuropathic pain symptoms severity, sensory function, state anxiety and subjective drug effects after CBD/CBD-A and placebo administration. The study involves a screening session, 2 study visits, and a follow-up visit. We will examine the effect of a single dose of a novel hemp-derived CBD/CBD-A oral soft gel product containing 217.7mg of CBD/CBD-A and other minor cannabinoids (THC, THC-A, CBG, CBG-A, Cultivate Biologics) compared to placebo on momentary neuropathic pain intensity and unpleasantness and EEG resting state. We hypothesize that compared to placebo, CBD/CBD-A will significantly reduce NP symptoms intensity and unpleasantness and normalize EEG activity.
Men or women, with moderate to severe chronic neuropathic pain,18-64 years of age, incomplete or complete traumatic SCI will take part of this study. Exclusion criteria include drug or alcohol abuse, significant medical illness or other significant neurological trauma, psychopathology and women who are pregnant, breastfeeding, or not practicing an effective form of birth control. Individuals with renal or hepatic disease, elevated serum creatinine, transaminases, or bilirubin, use of valproate, strong CYP2C19 and CYP3A4 inducers, suicidal ideation, hypersensitivity to cannabidiol or tetrahydrocannabinol, sesame seed oil, lecithin, or bovine gelatin will also be excluded.
The protocol has been approved by the FDA and the University of Miami’s IRB and is registered on clinical trials.gov (NCT05630235). The University of Miami clinical research monitoring process has been initiated. Potential participants have been identified, and we expect to start enrolling participants in March 2025.