A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effects and Mechanisms of a High CBD Cannabis Extract (BRC-002) for the Treatment of Pain and Health in Complex Regional Pain Syndrome
Overview
- Phase
- Phase 1
- Intervention
- BRC-002 Placebo
- Conditions
- Complex Regional Pain Syndrome
- Sponsor
- University of California, San Diego
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- Change in complex regional pain syndrome pain and heat pain measured with VAS
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Fadel Zeidan
Associate Professor
University of California, San Diego
Eligibility Criteria
Inclusion Criteria
- •Provision of signed and dated informed consent form.
- •Are between 21-75 years old
- •Ability to communicate in English
- •Volunteers with no previous medical history (e.g., cardiac or pulmonary disease)
- •Are not currently using any type of cannabis, including hemp or CBD
- •Currently 30 days cannabis free
- •Participants with ongoing CRPS \[Type 1 or Type 2)\] for at least 3 months prior to participation (medical record confirmed)
- •Agrees not to use cannabis, including hemp or CBD, outside of the study during participation in the study
- •Agrees not to use opioids or barbiturates during participation in the study
Exclusion Criteria
- •Fail cannabis screening
- •Active pulmonary disease
- •Allergy or past adverse effects or negative past experiences from cannabis
- •Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone prior to study session 1 or session 2
- •Any significant illness, including cardiovascular disease, diabetes, renal and liver disease
- •Any current or history of an immunocompromising disease or condition (such as lupus, psoriasis, multiple sclerosis, etc.)
- •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
- •Participant meets DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, psychosis, substance use disorder, or schizophrenia
- •Any current or history of suicidal ideation or attempt
- •Patients with clinically significant laboratory abnormalities
Arms & Interventions
Placebo Comparator: 1 Placebo
Half of the patients will receive PO placebo
Intervention: BRC-002 Placebo
Experimental: Active
Drug: BRC-002 (High Cannabidiol Botanical Extract) 100 mg/mL
Intervention: BRC-002
Outcomes
Primary Outcomes
Change in complex regional pain syndrome pain and heat pain measured with VAS
Time Frame: 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 Outcomes
- Sleep Measure(Day 1 - Day 42)
- Interleukin 6(Day 1 - Day 42)
- Pain Inventory Measure(Day 1 - Day 42)
- Depression Measure(Day 1 - Day 42)