RECRUITING

Effects of CBD/CBD-A Oral Extract on Resting-state EEG and Neuropathic Pain Symptoms After SCI

Conditions

SCI - Spinal Cord Injury Neuropathic Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Effects of a Hemp-derived Cannabidiol and Cannabidiolic-acid Oral Extract on Resting-state Electroencephalography and Neuropathic Pain Symptoms in People With Spinal Cord Injury

Quick Facts

Study Start:2025-03-30

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05630235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Men or Women; 2. 18-64 years of age with an incomplete or complete acquired traumatic SCI; 3. Must have experienced neuropathic pain for a minimum of three months before entering the study (neuropathic pain will be assessed using the International SCI Pain Classification); 4. The pain intensity must be in the moderate to severe category, which will be defined as a score of at least four on an NRS (range of 0 to 10). 5. Must have previous experience with consuming cannabis and or cannabinoids.	1. Current drug (DAST-10: \>6) or alcohol abuse (AUDIT: \>10); 2. Current use of cannabis plant or cannabis products (CBD or CBD+THC) or any other drugs of abuse (unless prescribed) including alcohol; 3. Presence of significant medical illness (e.g., diabetes, obesity, cardiovascular disease, hypertension, hepatitis) or other significant neurological trauma; 4. History of or current severe psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia, post-traumatic stress disorder) judged by the investigator to put the subject at greater risk of experiencing an adverse event; 5. 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; 6. Current pregnancy. Pregnancy will be evaluated using a pregnancy test during the first study visit. Female subjects of childbearing potential will be required to use two forms of effective birth control for the 3 months prior to participating in the study and continuing for 1 month after completion of the study; 7. Have a history of renal or hepatic disease: or 8. Have elevated serum creatinine above the laboratory upper limit of normal (ULN): or 9. Have elevated serum transaminases (ALT or AST) above the ULN: or 10. Have elevated total bilirubin above the ULN; or 11. Take valproate, due increased risk of liver enzyme elevation; or 12. Currently using strong CYP2C19 and CYP3A4 inducers; or 13. Have suicidal ideation (subjects should be screened for suicidal ideation); or 14. Cannot abstain from the use of alcohol during the study period, due to increased risk of sedation; or 15. Have a known or suspected hypersensitivity to cannabidiol or tetrahydrocannabinol. 16. Have a known or suspected hypersensitivity to sesame seed oil, lecithin, or bovine gelatin.

Inclusion Criteria

Exclusion Criteria

1. Men or Women;
2. 18-64 years of age with an incomplete or complete acquired traumatic SCI;
3. Must have experienced neuropathic pain for a minimum of three months before entering the study (neuropathic pain will be assessed using the International SCI Pain Classification);
4. The pain intensity must be in the moderate to severe category, which will be defined as a score of at least four on an NRS (range of 0 to 10).
5. Must have previous experience with consuming cannabis and or cannabinoids.

1. Current drug (DAST-10: \>6) or alcohol abuse (AUDIT: \>10);
2. Current use of cannabis plant or cannabis products (CBD or CBD+THC) or any other drugs of abuse (unless prescribed) including alcohol;
3. Presence of significant medical illness (e.g., diabetes, obesity, cardiovascular disease, hypertension, hepatitis) or other significant neurological trauma;
4. History of or current severe psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia, post-traumatic stress disorder) judged by the investigator to put the subject at greater risk of experiencing an adverse event;
5. 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;
6. Current pregnancy. Pregnancy will be evaluated using a pregnancy test during the first study visit. Female subjects of childbearing potential will be required to use two forms of effective birth control for the 3 months prior to participating in the study and continuing for 1 month after completion of the study;
7. Have a history of renal or hepatic disease: or
8. Have elevated serum creatinine above the laboratory upper limit of normal (ULN): or
9. Have elevated serum transaminases (ALT or AST) above the ULN: or
10. Have elevated total bilirubin above the ULN; or
11. Take valproate, due increased risk of liver enzyme elevation; or
12. Currently using strong CYP2C19 and CYP3A4 inducers; or
13. Have suicidal ideation (subjects should be screened for suicidal ideation); or
14. Cannot abstain from the use of alcohol during the study period, due to increased risk of sedation; or
15. Have a known or suspected hypersensitivity to cannabidiol or tetrahydrocannabinol.
16. Have a known or suspected hypersensitivity to sesame seed oil, lecithin, or bovine gelatin.

Contacts and Locations

Study Contact

Eva Widerstrom-Noga, PhD, DDS

CONTACT

+1 (305) 2437125

ewiderstrom-noga@med.miami.edu

Principal Investigator

Eva Widerstrom-Noga, PhD, DDS

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

Lynn Rehabilitation Center

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Eva Widerstrom-Noga, PhD, DDS, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-30

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2025-03-30

Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

SCI - Spinal Cord Injury
Neuropathic Pain