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
20
Lynn Rehabilitation Center
Miami, Florida, United States
RECRUITINGChange 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