Trial Summary
What is the purpose of this trial?
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).
Research Team
EW
Eva Widerstrom-Noga, PhD, DDS
Principal Investigator
University of Miami
Eligibility Criteria
This trial is for adults aged 18-64 with spinal cord injury who have been experiencing moderate to severe neuropathic pain for at least three months. Participants must not have significant medical illnesses, severe mental health disorders, current substance abuse issues, or be pregnant or breastfeeding without effective birth control.Inclusion Criteria
My pain level is at least a 4 out of 10.
My neuropathic pain has been evaluated with specific questionnaires.
I have had nerve pain for at least three months.
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Exclusion Criteria
I do not have a severe mental health condition like major depression, bipolar, schizophrenia, or PTSD.
I have a serious health condition like diabetes, heart disease, or liver problems.
You are currently misusing drugs or alcohol.
See 1 more
Treatment Details
Interventions
- CBD (Cannabinoid)
Trial OverviewThe study tests the effects of Cannabidiol (CBD) on neuropathic pain severity and brain activity in people with spinal cord injuries. It compares CBD's impact on pain symptoms and EEG readings against a placebo.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Placebo followed by CBD/CBD-A groupExperimental Treatment2 Interventions
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.
Group II: CBD/CBD-A followed by placebo groupExperimental Treatment2 Interventions
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.
CBD is already approved in Canada for the following indications:
Approved in Canada as Epidiolex for:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Lynn Rehabilitation CenterMiami, FL
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Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Trials
976
Patients Recruited
423,000+
Consortium for Medical Marijuana Clinical Outcomes Research
Collaborator
Trials
5
Patients Recruited
100+