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Cannabinoid

CBD for Neuropathic Pain in Spinal Cord Injury

Phase 1 & 2

Waitlist Available

Led By Eva Widerstorm-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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3 hours post intervention

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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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.

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

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in brain activity at rest.

Change in neuropathic pain intensity or unpleasantness.

Secondary outcome measures

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 groupExperimental Treatment2 Interventions

Participants in this group will receive placebo on day one followed by CBD within a two week follow-up visit.

Group II: CBD followed by placebo groupExperimental Treatment2 Interventions

Participants in this group will receive CBD on day one followed by placebo within a two week follow-up visit.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CBD

2016

Completed Phase 2

~440

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

899 Previous Clinical Trials

409,717 Total Patients Enrolled

3 Trials studying Neuropathic Pain

62 Patients Enrolled for Neuropathic Pain

Consortium for Medical Marijuana Clinical Outcomes ResearchOTHER

4 Previous Clinical Trials

101 Total Patients Enrolled

Eva Widerstorm-Noga, PhD, DDSPrincipal InvestigatorUniversity of Miami

Media Library

CBD (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05630235 — Phase 1 & 2

Neuropathic Pain Research Study Groups: CBD followed by placebo group, Placebo followed by CBD group

Neuropathic Pain 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation extend to those aged fifty or above?

"This study can only accept patients that are between 18 and 64 years of age. However, there are 230 studies for minors and 1150 trials for those over 65 available to explore."

Answered by AI

Are researchers presently seeking participants for this experiment?

"The clinical trial is not currently accepting participants, as the listing on clinicialtrials.gov shows that it was last updated on May 12th 2023. However, there are numerous other studies seeking volunteers with 1453 trials available at present."

Answered by AI

Who is eligible to volunteer for this clinical experiment?

"At the moment, this research is recruiting 15 individuals aged 18 to 64 who suffer from neuropathic pain. Notably, applicants must be male or female with either a complete or incomplete traumatic spinal cord injury."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Cannabidiol (CBD) on Resting-state Electroencephalography (EEG) and Neuropathic Pain Severity in People With Spinal Cord Injury (SCI)

Eva Widerstrom-Noga 2024. "Effects of Cannabidiol (CBD) on Resting-state Electroencephalography (EEG) and Neuropathic Pain Severity in People With Spinal Cord Injury (SCI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05630235.

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