Neuropathic Pain, SCI - Spinal Cord Injury
Conditions
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).
Interventions
DRUGCBD/CBD-A
Participants will be administered a one-time dose of 204.6 mg of CBD/CBD-A orally.
OTHERPlacebo
The placebo equivalent of the CBD/CBD-A dose administered orally.
Sponsors
University of Miami
Consortium for Medical Marijuana Clinical Outcomes Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in neuropathic pain intensity or unpleasantness. | Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention | 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 electrocortical activity at rest. | Baseline and 3 hours post intervention | Assess brain electrocortical activity at rest using a 64-channel Biosemi EEG system and conducting EEG power spectrum analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in neuropathic pain symptoms severity using the NPSI. | Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention | 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. | Baseline and 3 hours post intervention | Sensory function will be assessed using quantitative sensory testing (QST) using an FDA-approved Thermal Sensory Analyzer. |
| Change in state anxiety using the STAI. | Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention | 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. |
| Subjective Drug Effects | Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention | Drug Effects Questionnaire (DEQ): The DEQ is a brief five item instrument used to assess subjective drug effects. The five items are presented on a 100 mm visual analogue scale ranging from not at all to extremely. The participants are instructed to draw a vertical line at any place between the two responses |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREva Widerstrom-Noga, PhD, DDS
University of Miami
Outcome results
None listed