The Effects and Mechanisms of a High CBD Cannabis Extract (BRC-002) for the Treatment of Pain and Health in Complex Regional Pain Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BRC-002, BRC-002 Placebo.
- Who it may be relevant to
- Registry conditions: Complex Regional Pain Syndrome. Basic parameters: 21 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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
- Drug BRC-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. - Drug BRC-002 Placebo
Oral solution of mono-, di-, and triglycerides
Primary outcome measures
- Change in complex regional pain syndrome pain and heat pain measured with VAS [Time frame: Day 1 - Day 42]
Secondary outcome measures (4)
- Pain Inventory Measure [Time frame: Day 1 - Day 42]
- Depression Measure [Time frame: Day 1 - Day 42]
- Sleep Measure [Time frame: Day 1 - Day 42]
- Interleukin 6 [Time frame: Day 1 - Day 42]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Altman Clinical and Translational Research Institute — La Jolla
- University of California, San Diego — San Diego
Identifiers
NCT: NCT06393101 · 809767