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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
6
Lynn Rehabilitation Center
Miami, Florida, United States
Change in neuropathic pain intensity or unpleasantness.
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).
Time frame: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention
Change in brain electrocortical activity at rest.
Assess brain electrocortical activity at rest using a 64-channel Biosemi EEG system and conducting EEG power spectrum analysis
Time frame: Baseline and 3 hours post intervention
Change in neuropathic pain symptoms severity using the NPSI.
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.
Time frame: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention
Change in sensory function using QST.
Sensory function will be assessed using quantitative sensory testing (QST) using an FDA-approved Thermal Sensory Analyzer.
Time frame: Baseline and 3 hours post intervention
Change in state anxiety using the STAI.
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.
Time frame: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention
Subjective Drug Effects
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
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Time frame: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention