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| Name | Class |
|---|---|
| Consortium for Medical Marijuana Clinical Outcomes Research | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBD/CBD-A followed by placebo group | Experimental | 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. |
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| Placebo followed by CBD/CBD-A group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBD/CBD-A | Drug | Participants will be administered a one-time dose of 204.6 mg of CBD/CBD-A orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 | Baseline and 3 hours post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Widerstrom-Noga, PhD, DDS | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lynn Rehabilitation Center | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Placebo | Other | The placebo equivalent of the CBD/CBD-A dose administered orally. |
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| Change in sensory function using QST. | Sensory function will be assessed using quantitative sensory testing (QST) using an FDA-approved Thermal Sensory Analyzer. | 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. | 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 | Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention |
| D014947 | Wounds and Injuries |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |