Clinical trial NCT05630235: Effects of CBD/CBD-A Oral Extract on Resting-state EEG and Neuropathic Pain Symptoms After SCI
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: SCI - Spinal Cord Injury
Neuropathic Pain
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Consortium for Medical Marijuana Clinical Outcomes Research
First posted: 2022-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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).


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.

Primary outcomes:
measure: Change in neuropathic pain intensity or unpleasantness.
timeFrame: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention
measure: Change in brain electrocortical activity at rest.
timeFrame: Baseline and 3 hours post intervention
Secondary outcomes:
measure: Change in neuropathic pain symptoms severity using the NPSI.
timeFrame: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention
measure: Change in sensory function using QST.
timeFrame: Baseline and 3 hours post intervention
measure: Change in state anxiety using the STAI.
timeFrame: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention
measure: Subjective Drug Effects
timeFrame: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention
Other outcomes:
Locations:
city: Miami
country: United States
facility: Lynn Rehabilitation Center
state: Florida
Study officials:
affiliation: University of Miami
name: Eva Widerstrom-Noga, PhD, DDS
role: PRINCIPAL_INVESTIGATOR
References: