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

Complex Regional Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06393101
• Other study ID #: 809767
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 1, 2024
• Est. completion date: June 1, 2029

Study information

• Verified date: April 2024
• Source: University of California, San Diego
• Contact: Fadel Zeidan, PhD
• Phone: 858-246-8341
• Email: fzeidan[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: June 1, 2029
• Est. primary completion date: June 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome
• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

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.
• BRC-002 Placebo
Oral solution of mono-, di-, and triglycerides

Locations

Country	Name	City	State
United States	Altman Clinical and Translational Research Institute	La Jolla	California
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain Inventory Measure	Change from baseline in The Brief Pain Inventory	Day 1 - Day 42
Secondary	Depression Measure	Change from baseline in Beck Depression	Day 1 - Day 42
Secondary	Sleep Measure	Change from baseline in Pittsburgh Sleep Quality Index	Day 1 - Day 42
Secondary	Interleukin 6	Change from baseline in Interleukin 6	Day 1 - Day 42