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Cannabinoid

CBD for Neuropathic Pain in Spinal Cord Injury

Phase 1 & 2
Waitlist Available
Led By Eva Widerstrom-Noga, PhD, DDS
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The pain intensity must be in the moderate to severe category, which will be defined as a score of at least four on a numerical rating scale (NRS) (range of 0 to 10)
Must have experienced continuous neuropathic pain for a minimum of three months prior to entering the study
Must not have
Current severe psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia, post-traumatic stress disorder)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 hours post intervention

Summary

This trial studies the effects of CBD on pain & temperature sensations, as well as brain activity, using EEG.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While the side effects are not detailed here, CBD can typically cause tiredness, diarrhea, changes in appetite/weight. However, specific side effects related to this trial will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My pain level is at least a 4 out of 10.
Select...
I have had nerve pain for at least three months.
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I am between 18 and 64 years old with a spinal cord injury from an accident.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have a severe mental health condition like major depression, bipolar, schizophrenia, or PTSD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 hours post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 hours post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in brain electrocortical activity at rest.
Change in neuropathic pain intensity or unpleasantness.
Secondary study objectives
Change in neuropathic pain symptoms severity using the NPSI.
Change in sensory function using QST.
Change in state anxiety using the STAI.

Trial Design

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.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
947 Previous Clinical Trials
427,685 Total Patients Enrolled
Consortium for Medical Marijuana Clinical Outcomes ResearchOTHER
4 Previous Clinical Trials
82 Total Patients Enrolled
Eva Widerstrom-Noga, PhD, DDSPrincipal InvestigatorUniversity of Miami

Media Library

CBD (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05630235 — Phase 1 & 2
Spinal Cord Injury Research Study Groups: CBD/CBD-A followed by placebo group, Placebo followed by CBD/CBD-A group
Spinal Cord Injury Clinical Trial 2023: CBD Highlights & Side Effects. Trial Name: NCT05630235 — Phase 1 & 2
CBD (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05630235 — Phase 1 & 2
~13 spots leftby Jun 2026
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