The Effects and Mechanisms of a High CBD Cannabis Extract (BRC-002) for the Treatment of Pain and Health in Complex Regional Pain Syndrome

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

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.

Study Overview

• Status: Recruiting
• Conditions: Complex Regional Pain Syndrome
• Intervention / Treatment: Drug: BRC-002 Placebo; Drug: BRC-002

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 United States alone has a reported 200,000 individuals living with CRPS. 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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Fadel Zeidan, PhD; Phone Number: 858-246-8341; Email: fzeidan@health.ucsd.edu
• Study Contact Backup: Name: Yasmeen Esshaki, MS; Phone Number: 858-246-8341; Email: yesshaki@health.ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • Altman Clinical and Translational Research Institute
      • Contact: Fadel Zeidan, PhD; Phone Number: 62028 858-246-2028; Email: zeidanlab@ucsd.edu
      • Contact: Yasmeen Esshaki, MA; Phone Number: 62028 858-246-2028; Email: yesshaki@health.ucsd.edu
    • San Diego, California, United States, 92093
      • Recruiting
      • University of California, San Diego
      • Contact: Fadel Zeidan, PhD; Phone Number: 62028 858-246-2028; Email: fzeidan@health.ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Comparator: 1 Placebo; Half of the patients will receive PO placebo	Drug: BRC-002 Placebo; Oral solution of mono-, di-, and triglycerides
Experimental: Experimental: Active; Drug: BRC-002 (High Cannabidiol Botanical Extract) 100 mg/mL	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Fadel Zeidan, PhD, UC San Diego

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Pain; CRPS; Complex Regional Pain Syndrome; Cannabis
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Syndrome; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Somatoform Disorders
• Other Study ID Numbers: 809767

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No