Actively Recruiting
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
Led by University of Miami · Updated on 2025-06-17
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
C
Consortium for Medical Marijuana Clinical Outcomes Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of a hemp-derived oral extract containing cannabidiol (CBD) and cannabidiolic acid (CBD-A) on neuropathic pain symptoms and brain electrical activity in people with spinal cord injury (SCI). The study aims to measure changes in pain intensity, unpleasantness, and skin sensitivity to hot and cold temperatures, as well as changes in brain activity using electroencephalography (EEG). Participants receive either a one-time oral dose of 204.6 mg of CBD/CBD-A or a placebo in a randomized, double-blind design. One group receives CBD/CBD-A first followed by placebo after two weeks, while the other group receives placebo first followed by CBD/CBD-A after two weeks. This crossover design allows comparison of the extract's effects against placebo within the same participants. During the study, participants will be assessed at baseline and then approximately 3 and 6 hours after each intervention. Evaluations include neuropathic pain intensity and unpleasantness, brain EEG activity, sensory function tests, anxiety levels, and subjective drug effects. This detailed monitoring helps researchers understand the short-term impact of CBD/CBD-A on pain and brain function in individuals with SCI-related neuropathic pain.
CONDITIONS
Brief Title
Effects of CBD/CBD-A Oral Extract on Resting-state EEG and Neuropathic Pain Symptoms After SCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 to 64 years
- Have an incomplete or complete acquired traumatic spinal cord injury
- Experience neuropathic pain for at least three months before joining the study
- Have moderate to severe pain intensity, scoring at least 4 on a 0 to 10 scale
- Have previous experience with consuming cannabis or cannabinoids
You will not qualify if you...
- Current drug abuse (DAST-10 score above 6) or alcohol abuse (AUDIT score above 10)
- Currently using cannabis products (CBD or CBD+THC), other drugs of abuse, or alcohol unless prescribed
- Have significant medical illnesses such as diabetes, obesity, cardiovascular disease, hypertension, or hepatitis
- History or current severe psychiatric disorders including major depression, bipolar disorder, schizophrenia, or PTSD
- Unable to consent, pregnant, breastfeeding, not using effective birth control, or prisoner
- Current pregnancy or not using two forms of effective birth control if of childbearing potential
- History of kidney or liver disease
- Elevated liver enzymes or bilirubin above normal limits
- Taking valproate or strong CYP2C19 and CYP3A4 inducers
- Suicidal thoughts
- Cannot abstain from alcohol during the study
- Known allergy to cannabidiol, tetrahydrocannabinol, sesame seed oil, lecithin, or bovine gelatin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 weeks
Participants receive a one-time oral dose of CBD/CBD-A or placebo, followed by the alternate treatment after a two-week period.
3 visits (in-person)
Trial Site Locations
Total: 1 location
1
Lynn Rehabilitation Center
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
E
Eva Widerstrom-Noga, PhD, DDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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