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

NCT ID: NCT06393101

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2029-06-01

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.

Conditions

Complex Regional Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Comparator: 1 Placebo

Half of the patients will receive PO placebo

Group Type: PLACEBO_COMPARATOR

BRC-002 Placebo

Intervention Type: DRUG

Oral solution of mono-, di-, and triglycerides

Experimental: Active

Drug: BRC-002 (High Cannabidiol Botanical Extract) 100 mg/mL

Group Type: EXPERIMENTAL

BRC-002

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

BRC-002 Placebo

Oral solution of mono-, di-, and triglycerides

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Fadel Zeidan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fadel Zeidan, PhD

Role: PRINCIPAL_INVESTIGATOR

UC San Diego

Locations

Altman Clinical and Translational Research Institute

La Jolla, California, United States

Site Status: RECRUITING

University of California, San Diego

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Fadel Zeidan, PhD

Role: CONTACT

fzeidan@health.ucsd.edu

858-246-8341

Yasmeen Esshaki, MS

Role: CONTACT

yesshaki@health.ucsd.edu

858-246-8341

Facility Contacts

Fadel Zeidan, PhD

Role: primary

zeidanlab@ucsd.edu

858-246-2028 ext. 62028

Yasmeen Esshaki, MA

Role: backup

yesshaki@health.ucsd.edu

858-246-2028 ext. 62028

Fadel Zeidan, PhD

Role: primary

fzeidan@health.ucsd.edu

858-246-2028 ext. 62028

Other Identifiers

809767

Identifier Type: -

Identifier Source: org_study_id