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

NCT06393101 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 809767
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Complex Regional Pain Syndrome

Keywords

Complex Regional Pain Syndrome; CRPS; Cannabis; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain Inventory Measure

  Day 1 - Day 42

• Depression Measure

  Day 1 - Day 42

• Sleep Measure

  Day 1 - Day 42

• Interleukin 6

  Day 1 - Day 42

Study Arms (2)

Placebo Comparator: 1 Placebo

PLACEBO COMPARATOR

Half of the patients will receive PO placebo

Drug: BRC-002 Placebo

Experimental: Active

EXPERIMENTAL

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

Drug: BRC-002

Interventions

BRC-002 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.

Experimental: Active

BRC-002 Placebo DRUG

Oral solution of mono-, di-, and triglycerides

Placebo Comparator: 1 Placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (2)

Altman Clinical and Translational Research Institute

La Jolla, California, 92093, United States

RECRUITING

University of California, San Diego

San Diego, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Marijuana Abuse; Pain

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fadel Zeidan, PhD

  UC San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fadel Zeidan, PhD

CONTACT

858-246-8341; fzeidan@health.ucsd.edu

Yasmeen Esshaki, MS

CONTACT

858-246-8341; yesshaki@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 1, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)