CBD Cannabis Extract for Complex Regional Pain Syndrome

Recruiting at 1 trial location

Overseen By Yasmeen Esshaki, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, San Diego

Must not be taking: Cannabis, Opioids, Barbiturates, others

Disqualifiers: Pulmonary disease, Cardiovascular disease, Diabetes, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a cannabis extract, BRC-002 (also known as High CBD Cannabis Extract), can reduce pain in individuals with complex regional pain syndrome (CRPS), a condition causing long-lasting pain, often in an arm or leg. Researchers will compare the effectiveness of BRC-002 to a placebo (a treatment with no active drug) by examining both psychological and physical effects on participants. The trial is suitable for individuals who have lived with CRPS for at least three months and are not currently using any cannabis products. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you do not use cannabis, hemp, CBD, opioids, or barbiturates during participation. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that treatments with high CBD (cannabidiol) extracts, such as BRC-002, have been studied for safety in people with complex regional pain syndrome (CRPS). Previous studies suggest that cannabis-based medicines might relieve pain and improve the quality of life for CRPS patients. These treatments are usually well-tolerated, with most people not experiencing serious side effects.

At this early research stage, the main goal is to ensure the medication's safety. Since this trial is in its first phase, it focuses on the treatment's safety and how people respond to it. Early trials like this help researchers identify any side effects and their severity.

So far, similar studies have not reported major concerns, suggesting BRC-002 might be safe for people. However, as this is an early trial, more research is needed to confirm these findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for complex regional pain syndrome?

Unlike the standard treatments for Complex Regional Pain Syndrome (CRPS), which often include pain medications, physical therapy, and nerve blocks, BRC-002 offers a unique approach by utilizing a high cannabidiol (CBD) botanical extract. This treatment stands out due to its potential to leverage CBD's anti-inflammatory and analgesic properties, which may provide pain relief without the psychoactive effects associated with other cannabis components like THC. Researchers are particularly excited about BRC-002 because it targets the endocannabinoid system, offering a novel mechanism of action that could potentially provide more effective pain management for CRPS patients.

What evidence suggests that BRC-002 might be an effective treatment for CRPS?

Research has shown that cannabidiol (CBD) products, such as BRC-002, might help reduce pain and improve the quality of life for people with complex regional pain syndrome (CRPS). In this trial, some participants will receive BRC-002, a high cannabidiol botanical extract, to evaluate its effectiveness. Studies have found that cannabinoids can significantly relieve pain. Specifically, data from the UK Medical Cannabis Registry indicated that cannabis-based medicines can improve both pain management and overall health for CRPS patients. Cannabinoids interact with the body's endocannabinoid system, which helps regulate pain. These findings offer hope that BRC-002 could effectively treat pain related to CRPS. ^{1 2 4 6 7}

Who Is on the Research Team?

Fadel Zeidan, PhD

Principal Investigator

UC San Diego

Are You a Good Fit for This Trial?

This trial is for individuals with Complex Regional Pain Syndrome (CRPS), a condition causing persistent severe pain. Participants should be experiencing CRPS-related pain and may have associated health issues like somatoform disorders. Details on specific inclusion or exclusion criteria are not provided, but typically these would outline who can safely participate based on factors like age, disease severity, and other medical conditions.

Inclusion Criteria

Volunteers with no previous medical history (e.g., cardiac or pulmonary disease)

Currently 30 days cannabis free

Provision of signed and dated informed consent form

Exclusion Criteria

Any current or history of suicidal ideation or attempt

I have or had an immune system disease like lupus or MS.

Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone prior to study session 1 or session 2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study medication (BRC-002 or placebo) for 6 weeks

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BRC-002

Trial Overview The study is testing BRC-002, a high CBD cannabis extract, to see if it helps with CRPS pain and overall health. It involves comparing the effects of BRC-002 against a placebo over six weeks of treatment followed by two weeks of follow-up. The trial will also explore how cannabinoids might relieve pain through various physical and psychological tests along with inflammation marker assessments.

How Is the Trial Designed?

Group I: Experimental: Active Experimental Treatment 1 Intervention

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

Group II: Placebo Comparator: 1 Placebo Placebo Group 1 Intervention

Half of the patients will receive PO placebo

BRC-002 is already approved in United States for the following indications:

Approved in United States as BRC-002 for:

• Orphan Drug Designation for Complex Regional Pain Syndrome (CRPS)

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

In a rat model of diabetic neuropathy, different cannabis formulations (pure THC, pure CBD, a 1:1 THC:CBD mix, and a balanced extract) produced distinct pain relief effects, indicating that their effectiveness cannot be solely determined by THC and CBD content.

The study revealed that the engagement of cannabinoid receptors (CB1, CB2) and TRPV1 channels varied significantly among the different formulations, suggesting that the specific composition of cannabinoids is crucial for achieving desired analgesic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A type II cannabis extract and a 1:1 blend of Δ(9)-tetrahydrocannabinol and cannabidiol display distinct antinociceptive profiles and engage different endocannabinoid targets when administered into the subarachnoid space. Benredjem, B., Pineyro, G.[2023]

In an in vitro study using rat dorsal root ganglion neurons, individual cannabinoids (CBG, CBD, and THC) showed dose-dependent inhibition of capsaicin responses, indicating their potential as effective analgesics.

The combination of CBG, CBD, and THC at a 1:1:1 ratio enhanced the analgesic effects compared to individual cannabinoids, suggesting that using these compounds together could improve pain relief and tolerability, warranting further in vivo research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-Related Inhibition of Capsaicin Responses by Cannabinoids CBG, CBD, THC and their Combination in Cultured Sensory Neurons. Anand, U., Oldfield, C., Pacchetti, B., et al.[2022]

In a study of 177 patients with advanced cancer pain, the THC:CBD extract significantly reduced pain more than placebo, with an average improvement of -1.37 on the pain scale compared to -0.69 for placebo.

The THC extract did not show a significant difference in pain relief compared to placebo, indicating that THC:CBD may be more effective for pain management in patients who do not respond adequately to opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain. Johnson, JR., Burnell-Nugent, M., Lossignol, D., et al.[2022]

In a study using a chronic postischemia pain model in mice, local administration of cannabidiol (CBD) was found to significantly reduce mechanical hyperalgesia, suggesting its potential as a treatment for complex regional pain syndrome type I (CRPS-I).

The study indicated that the antihyperalgesic effects of CBD may involve cannabinoid receptor CB1 and TRPM8, although ischemia/reperfusion did not alter the levels of CB1 and CB2 receptors in the muscle tissues, highlighting a complex interaction in pain modulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex Regional Pain Syndrome Type I: Evidence for the CB1 and CB2 Receptors Immunocontent and Beneficial Effect of Local Administration of Cannabidiol in Mice. Buffon, AC., Salm, DC., Heymanns, AC., et al.[2023]

In a study involving 48 patients with chronic pain from brachial plexus root avulsion, cannabis-based medicines did not achieve the hypothesized two-point reduction in pain severity, but did show statistically significant improvements in pain-related quality of life and sleep.

The cannabis treatments, including Sativex and another THC-dominant extract, were generally well tolerated, with most side effects being mild to moderate and resolving on their own, suggesting a favorable safety profile for these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of two cannabis based medicinal extracts for relief of central neuropathic pain from brachial plexus avulsion: results of a randomised controlled trial. Berman, JS., Symonds, C., Birch, R.[2021]

In a study of 800 patients with severe chronic pain, the oromucosal spray containing THC and CBD resulted in a significant average symptom relief improvement of 39% after 12 weeks, with particularly strong effects observed in patients with neuropathic pain.

The treatment was generally well-tolerated, with 19.9% of patients reporting mild side effects, such as increased appetite and changes in taste, and only 4% discontinuing due to adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and tolerability of THC:CBD oromucosal spray as add-on measure in patients with severe chronic pain: analysis of 12-week open-label real-world data provided by the German Pain e-Registry. Ueberall, MA., Essner, U., Mueller-Schwefe, GH.[2020]

Patients with complex regional pain syndrome (CRPS) type I have significantly higher levels of the endocannabinoid anandamide in their plasma compared to healthy controls, suggesting activation of the endocannabinoid system (ECS) in response to this condition.

The study indicates a potential link between chronic stress, the ECS, and the inflammatory processes involved in CRPS, highlighting the need for further research to explore how the ECS might help manage inflammation and pain in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced anandamide plasma levels in patients with complex regional pain syndrome following traumatic injury: a preliminary report. Kaufmann, I., Hauer, D., Huge, V., et al.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06393101

The Effects and Mechanisms of a High CBD Cannabis ... The aim of this trial is to determine the potential effects and mechanisms of cannabinoid-induced pain relief in complex regional pain syndrome (CRPS).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12405601/

UK Medical Cannabis Registry: A Clinical Outcomes Analysis ... CBMPs may confer promising improvements in pain relief and health‐related quality of life for patients with complex regional pain syndrome ...

3. trialx.com trialx.com/clinical-trials/listings/289725/the-effects-and-mechanisms-of-a-high-cbd-cannabis-extract-brc-002-for-the-treatment-of-pain-and-health-in-complex-regional-pain-syndrome/?&radius=50

The Effects and Mechanisms of a High CBD Cannabis ... The aim of this trial is to determine the potential effects and mechanisms of cannabinoid-induced pain relief in complex regional pain syndrome (CRPS).

4. withpower.com withpower.com/trial/early-phase-1-syndrome-5-2024-47544

CBD Cannabis Extract for 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).

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/brb3.70823

UK Medical Cannabis Registry: A Clinical Outcomes ... CBMPs may confer promising improvements in pain relief and health-related quality of life for patients with complex regional pain syndrome ...

6. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT06393101

UCSD Complex Regional Pain Syndrome Trial → Effects and ... The aim of this trial is to determine the potential effects and mechanisms of cannabinoid-induced pain relief in complex regional pain syndrome (CRPS).

7. prnewswire.com prnewswire.com/news-releases/biopharmaceutical-research-company-announces-first-dose-of-brc-002-a-first-in-class-cannabinoid-therapeutic-for-complex-regional-pain-syndrome-crps-in-investigator-initiated-study-302266003.html

Biopharmaceutical Research Company Announces First ... BRC-002 is a first-in-class therapeutic product candidate aiming to address pain and co-morbidities of CRPS.