Complex Regional Pain Syndrome
Conditions
Keywords
Complex Regional Pain Syndrome, CRPS, Cannabis, Pain
Brief summary
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.
Detailed description
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.
Interventions
DRUGBRC-002
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.
DRUGBRC-002 Placebo
Oral solution of mono-, di-, and triglycerides
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated informed consent form. 2. Are between 21-75 years old 3. Ability to communicate in English 4. Volunteers with no previous medical history (e.g., cardiac or pulmonary disease) 5. Are not currently using any type of cannabis, including hemp or CBD 6. Currently 30 days cannabis free 7. Participants with ongoing CRPS \[Type 1 or Type 2)\] for at least 3 months prior to participation (medical record confirmed) 8. Agrees not to use cannabis, including hemp or CBD, outside of the study during participation in the study 9. Agrees not to use opioids or barbiturates during participation in the study
Exclusion criteria
1. Fail cannabis screening 2. Active pulmonary disease 3. Allergy or past adverse effects or negative past experiences from cannabis 4. Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone prior to study session 1 or session 2 5. Any significant illness, including cardiovascular disease, diabetes, renal and liver disease 6. Any current or history of an immunocompromising disease or condition (such as lupus, psoriasis, multiple sclerosis, etc.) 7. Any current or history of neurologic conditions, including Parkinson disease, dementia, cognitive impairment, history of seizure disorder, and history of traumatic brain injury/head injury 8. Participant meets DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, psychosis, substance use disorder, or schizophrenia 9. Any current or history of suicidal ideation or attempt 10. Patients with clinically significant laboratory abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in complex regional pain syndrome pain and heat pain measured with VAS | Day 1 - Day 42 | Change from baseline in pain intensity and unpleasantness ratings using an 11-point Visual Analog Scale in response to heat and ongoing CRPS pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Inventory Measure | Day 1 - Day 42 | Change from baseline in The Brief Pain Inventory |
| Depression Measure | Day 1 - Day 42 | Change from baseline in Beck Depression |
| Sleep Measure | Day 1 - Day 42 | Change from baseline in Pittsburgh Sleep Quality Index |
| Interleukin 6 | Day 1 - Day 42 | Change from baseline in Interleukin 6 |
Countries
United States
Contacts
Primary ContactFadel Zeidan, PhD
Backup ContactYasmeen Esshaki, MS
Outcome results
None listed