Actively Recruiting
Effects of CBD/CBD-A Oral Extract on Resting-state EEG and Neuropathic Pain Symptoms After SCI
Led by University of Miami · Updated on 2025-06-17
20
Participants Needed
1
Research Sites
54 weeks
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
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
Official 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
- Experienced neuropathic pain for at least three months before the study
- Neuropathic pain intensity of at least 4 on a scale from 0 to 10
- Previous experience with consuming cannabis or cannabinoids
You will not qualify if you...
- Current drug abuse (DAST-10 >6) or alcohol abuse (AUDIT >10)
- Current use of cannabis products (CBD or CBD+THC) or other drugs of abuse unless prescribed, including alcohol
- Presence of significant medical illnesses like diabetes, obesity, cardiovascular disease, hypertension, hepatitis, or other neurological trauma
- History or current severe mental health conditions such as major depressive disorder, bipolar disorder, schizophrenia, or PTSD
- Unable to consent, pregnant, breastfeeding, not using effective birth control, or prisoner
- Current pregnancy as confirmed by test at first visit; women of childbearing potential must use two effective birth control methods for 3 months before and 1 month after the study
- History of kidney or liver disease
- Elevated serum creatinine, liver enzymes (ALT or AST), or total bilirubin above normal limits
- Taking valproate due to risk of liver enzyme elevation
- Using strong CYP2C19 and CYP3A4 inducers
- Suicidal ideation
- Unable to abstain from alcohol during the study
- Known or suspected allergy to cannabidiol, tetrahydrocannabinol, sesame seed oil, lecithin, or bovine gelatin
AI-Screening
AI-Powered Screening
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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
CONTACT
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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