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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 belowSelect...
My pain level is at least a 4 out of 10.
Select...
I have had nerve pain for at least three months.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 3 hours post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 hours post intervention
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
949 Previous Clinical Trials
428,444 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
Eligibility Criteria:
This trial includes the following eligibility 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.I am between 18 and 64 years old with a spinal cord injury from an accident.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.You cannot decide for yourself about joining the study, you are pregnant, breastfeeding, not using birth control, or in prison.
Research Study Groups:
This trial has the following groups:- Group 1: CBD/CBD-A followed by placebo group
- Group 2: Placebo followed by CBD/CBD-A group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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