Back to resultsEffects of Cannabidiol (CBD) on Resting-state Electroencephalography (EEG) and Neuropathic Pain Severity in People With Spinal Cord Injury (SCI)
Primary Purpose
SCI - Spinal Cord Injury, Neuropathic Pain
Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CBD
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for SCI - Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria: Men or women 18-64 years of age with an incomplete or complete traumatic SCI. Must have experienced continuous neuropathic pain for a minimum of three months prior to entering the study. Neuropathic pain will be assessed and classified using the International Spinal Cord Injury Basic Pain Dataset (ISCIBPD), the Neuropathic Pain Symptom Inventory, the International SCI pain classification, and the Douleur Neuropathique (DN-4) Questionnaire. 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). Exclusion Criteria: Current drug or alcohol abuse. Presence of significant medical illness (e.g., diabetes, obesity, cardiovascular disease, hypertension, hepatitis) or other significant neurological trauma. Current severe psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia, post-traumatic stress disorder). Adults who are unable to consent, women who are pregnant, breastfeeding, or not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD), and prisoners. Pregnancy will be evaluated using a pregnancy test during the screening session. Women had to be on birth control for a minimum of 3 months before participating in the study, and can stop birth control after 1 month.
Sites / Locations
- Lynn Rehabilitation Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CBD followed by placebo group
Placebo followed by CBD group
Arm Description
Participants in this group will receive CBD on day one followed by placebo within a two week follow-up visit.
Participants in this group will receive placebo on day one followed by CBD within a two week follow-up visit.
Outcomes
Primary Outcome Measures
Change in neuropathic pain intensity or unpleasantness.
Assess changes in pain intensity and unpleasantness of the worst neuropathic pain using a numerical rating scale from 0-10 (0 no pain and 10 worst imaginable/unpleasant pain).
Change in brain activity at rest.
Assess brain activity using a 64-channel Biosemi EEG system.
Secondary Outcome Measures
Change in neuropathic pain symptoms severity using the NPSI.
The Neuropathic Pain Symptom Inventory (NPSI) will assess the presence and severity of common neuropathic pain symptoms. Range 0-100 with higher scores representing greater neuropathic pain symptoms.
Change in sensory function using QST.
Sensory function will be assessed using quantitative sensory testing (QST) using an FDA-approved Thermal Sensory Analyzer.
Change in state anxiety using the STAI.
Using the State-trait Anxiety Inventory (STAI), we will evaluate changes in momentary anxiety with scores ranging from 5-20. Higher values equate to greater anxiety symptoms.
Full Information
NCT ID
NCT05630235
First Posted
November 18, 2022
Last Updated
July 10, 2023
Sponsor
University of Miami
Collaborators
Consortium for Medical Marijuana Clinical Outcomes Research
1. Study Identification
Unique Protocol Identification Number
NCT05630235
Brief Title
Effects of Cannabidiol (CBD) on Resting-state Electroencephalography (EEG) and Neuropathic Pain Severity in People With Spinal Cord Injury (SCI)
Official Title
Effects of Cannabidiol (CBD) on Resting-state Electroencephalography (EEG) and Neuropathic Pain Severity in People With Spinal Cord Injury (SCI)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Consortium for Medical Marijuana Clinical Outcomes Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purposes of this study are to (1) measure the effect of CBD on pain symptoms, pain intensity, pain unpleasantness, and skin sensitivity to hot and cold temperature; and (2) measure the effect of CBD on brain electrical activity with electroencephalography (EEG).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SCI - Spinal Cord Injury, Neuropathic Pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBD followed by placebo group
Arm Type
Experimental
Arm Description
Participants in this group will receive CBD on day one followed by placebo within a two week follow-up visit.
Arm Title
Placebo followed by CBD group
Arm Type
Experimental
Arm Description
Participants in this group will receive placebo on day one followed by CBD within a two week follow-up visit.
Intervention Type
Drug
Intervention Name(s)
CBD
Intervention Description
Participants will be administered a one time dose of 250mg of CBD orally.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo equivalent of the CBD oil administered orally.
Primary Outcome Measure Information:
Title
Change in neuropathic pain intensity or unpleasantness.
Description
Assess changes in pain intensity and unpleasantness of the worst neuropathic pain using a numerical rating scale from 0-10 (0 no pain and 10 worst imaginable/unpleasant pain).
Time Frame
Baseline and 3 hours post intervention
Title
Change in brain activity at rest.
Description
Assess brain activity using a 64-channel Biosemi EEG system.
Time Frame
Baseline and 3 hours post intervention
Secondary Outcome Measure Information:
Title
Change in neuropathic pain symptoms severity using the NPSI.
Description
The Neuropathic Pain Symptom Inventory (NPSI) will assess the presence and severity of common neuropathic pain symptoms. Range 0-100 with higher scores representing greater neuropathic pain symptoms.
Time Frame
Baseline and 3 hours post intervention
Title
Change in sensory function using QST.
Description
Sensory function will be assessed using quantitative sensory testing (QST) using an FDA-approved Thermal Sensory Analyzer.
Time Frame
Baseline and 3 hours post intervention
Title
Change in state anxiety using the STAI.
Description
Using the State-trait Anxiety Inventory (STAI), we will evaluate changes in momentary anxiety with scores ranging from 5-20. Higher values equate to greater anxiety symptoms.
Time Frame
Baseline and 3 hours post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men or women
18-64 years of age with an incomplete or complete traumatic SCI.
Must have experienced continuous neuropathic pain for a minimum of three months prior to entering the study. Neuropathic pain will be assessed and classified using the International Spinal Cord Injury Basic Pain Dataset (ISCIBPD), the Neuropathic Pain Symptom Inventory, the International SCI pain classification, and the Douleur Neuropathique (DN-4) Questionnaire.
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).
Exclusion Criteria:
Current drug or alcohol abuse.
Presence of significant medical illness (e.g., diabetes, obesity, cardiovascular disease, hypertension, hepatitis) or other significant neurological trauma.
Current severe psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia, post-traumatic stress disorder).
Adults who are unable to consent, women who are pregnant, breastfeeding, or not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD), and prisoners. Pregnancy will be evaluated using a pregnancy test during the screening session. Women had to be on birth control for a minimum of 3 months before participating in the study, and can stop birth control after 1 month.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas P Cherup, PhD
Phone
305-243-4145
Email
npc34@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Widerstorm-Noga, PhD, DDS
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lynn Rehabilitation Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas P Cherup, PhD
Phone
305-243-4145
Email
npc34@miami.edu
First Name & Middle Initial & Last Name & Degree
Eva Widerstrom-Noga, PhD, DDS
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Cannabidiol (CBD) on Resting-state Electroencephalography (EEG) and Neuropathic Pain Severity in People With Spinal Cord Injury (SCI)
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