Effects of CBD/CBD-A Oral Extract on Resting-state EEG and Neuropathic Pain Symptoms After SCI
- Conditions
- SCI - Spinal Cord InjuryNeuropathic Pain
- Interventions
- Drug: CBD/CBD-AOther: Placebo
- Registration Number
- NCT05630235
- Lead Sponsor
- University of Miami
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Men or Women;
- 18-64 years of age with an incomplete or complete acquired traumatic SCI;
- 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);
- 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).
- Must have previous experience with consuming cannabis and or cannabinoids.
- Current drug (DAST-10: >6) or alcohol abuse (AUDIT: >10);
- Current use of cannabis plant or cannabis products (CBD or CBD+THC) or any other drugs of abuse (unless prescribed) including alcohol;
- Presence of significant medical illness (e.g., diabetes, obesity, cardiovascular disease, hypertension, hepatitis) or other significant neurological trauma;
- 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;
- 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;
- 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;
- Have a history of renal or hepatic disease: or
- Have elevated serum creatinine above the laboratory upper limit of normal (ULN): or
- Have elevated serum transaminases (ALT or AST) above the ULN: or
- Have elevated total bilirubin above the ULN; or
- Take valproate, due increased risk of liver enzyme elevation; or
- Currently using strong CYP2C19 and CYP3A4 inducers; or
- Have suicidal ideation (subjects should be screened for suicidal ideation); or
- Cannot abstain from the use of alcohol during the study period, due to increased risk of sedation; or
- Have a known or suspected hypersensitivity to cannabidiol or tetrahydrocannabinol.
- Have a known or suspected hypersensitivity to sesame seed oil, lecithin, or bovine gelatin.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CBD/CBD-A followed by placebo group CBD/CBD-A 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. CBD/CBD-A followed by placebo group Placebo 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. Placebo followed by CBD/CBD-A group CBD/CBD-A 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. Placebo followed by CBD/CBD-A group Placebo 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Lynn Rehabilitation Center
🇺🇸Miami, Florida, United States