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

NCT ID: NCT05630235

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-16
• Study Completion Date: 2026-06-30

Brief Summary

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).

Conditions

SCI - Spinal Cord Injury; Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

CBD/CBD-A followed by placebo group

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.

Group Type: EXPERIMENTAL

CBD/CBD-A

Intervention Type: DRUG

Participants will be administered a one-time dose of 204.6 mg of CBD/CBD-A orally.

Placebo

Intervention Type: OTHER

The placebo equivalent of the CBD/CBD-A dose administered orally.

Placebo followed by CBD/CBD-A group

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 Type: EXPERIMENTAL

CBD/CBD-A

Intervention Type: DRUG

Participants will be administered a one-time dose of 204.6 mg of CBD/CBD-A orally.

Placebo

Intervention Type: OTHER

The placebo equivalent of the CBD/CBD-A dose administered orally.

Interventions

CBD/CBD-A

Participants will be administered a one-time dose of 204.6 mg of CBD/CBD-A orally.

Intervention Type: DRUG

Placebo

The placebo equivalent of the CBD/CBD-A dose administered orally.

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consortium for Medical Marijuana Clinical Outcomes Research

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Eva Widerstrom-Noga

Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva Widerstrom-Noga, PhD, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

Lynn Rehabilitation Center

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Eva Widerstrom-Noga, PhD, DDS

Role: CONTACT

ewiderstrom-noga@med.miami.edu

+1 (305) 2437125

Facility Contacts

Eva Widerstrom-Noga, PhD, DDS

Role: primary

ewiderstrom-noga@med.miami.edu

305-243-7125

Other Identifiers

20220782

Identifier Type: -

Identifier Source: org_study_id