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The aim of this trial is to determine the potential effects and mechanisms of cannabinoid-induced pain relief in complex regional pain syndrome (CRPS). Multiple psychophysical approaches will be conducted in conjunction with psychological and inflammatory marker testing to determine if and how cannabinoids produce stabilized improvement in CRPS-related pain and comorbidities.
The trial consisted of a pre-treatment screening period, six-week treatment period and a two-week follow-up.
Complex Regional Pain Syndrome (CRPS) is a debilitating and perplexing chronic pain condition that produces incalculable suffering to millions of individuals worldwide. The enigmatic nature of CRPS has left it difficult to treat. CRPS is characterized by a constellation of pain, sensory, autonomic, and motor symptoms that is difficult to pinpoint the source of injury/inflammation. Although unclear, a common cause of CRPS are radial fractures that demonstrate aberrant processing 4-6 weeks after injury.
The aim of this trial is to determine the potential effects and mechanisms of cannabinoid-induced pain relief in complex regional pain syndrome (CRPS). Multiple psychophysical approaches will be conducted in conjunction with psychological and inflammatory marker testing to determine if and how cannabinoids produce stabilized improvement in CRPS-related pain and comorbidities.
The trial consisted of a pre-treatment screening period, six-week treatment period and a two-week follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Comparator: 1 Placebo | Placebo Comparator | Half of the patients will receive PO placebo |
|
| Experimental: Active | Experimental | Drug: BRC-002 (High Cannabidiol Botanical Extract) 100 mg/mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRC-002 | Drug | BRC-002 is a non-scheduled cannabidiolic (CBD) formulation (<.3% THC). The cannabinoids in BRC-002 are naturally biosynthesized within the Cannabis sativa L. plant as acidic forms of CBD (cannabidiolic acid; CBDA), THC (tetrahydrocannabinolic acid; THCA) and other minor cannabinoids. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in complex regional pain syndrome pain and heat pain measured with VAS | Change from baseline in pain intensity and unpleasantness ratings using an 11-point Visual Analog Scale in response to heat and ongoing CRPS pain | Day 1 - Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Inventory Measure | Change from baseline in The Brief Pain Inventory | Day 1 - Day 42 |
| Depression Measure | Change from baseline in Beck Depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fadel Zeidan, PhD | Contact | 858-246-8341 | fzeidan@health.ucsd.edu | |
| Yasmeen Esshaki, MS | Contact | 858-246-8341 | yesshaki@health.ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Fadel Zeidan, PhD | UC San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altman Clinical and Translational Research Institute | Recruiting | La Jolla | California | 92093 | United States |
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|
| BRC-002 Placebo | Drug | Oral solution of mono-, di-, and triglycerides |
|
| Day 1 - Day 42 |
| Sleep Measure | Change from baseline in Pittsburgh Sleep Quality Index | Day 1 - Day 42 |
| Interleukin 6 | Change from baseline in Interleukin 6 | Day 1 - Day 42 |
| University of California, San Diego | Recruiting | San Diego | California | 92093 | United States |
|
| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| D002189 | Marijuana Abuse |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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