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

Trial Summary

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.

What data supports the effectiveness of the drug BRC-002, a high CBD cannabis extract, for treating Complex Regional Pain Syndrome?

Research suggests that CBD (cannabidiol) may help reduce pain in conditions like Complex Regional Pain Syndrome by interacting with cannabinoid receptors in the body. Studies have shown that CBD can have beneficial effects on pain and inflammation, which are key issues in this condition. ^{1 2 3 4 5}

How does the drug BRC-002 differ from other treatments for Complex Regional Pain Syndrome?

BRC-002, a high CBD cannabis extract, is unique because it focuses on cannabidiol (CBD), which has shown potential in reducing pain and inflammation by interacting with cannabinoid receptors in the body. Unlike traditional pain medications, this drug may offer a novel approach by targeting the endocannabinoid system, which is often activated in conditions like Complex Regional Pain Syndrome. ^{1 2 5 6 7}

What is the purpose of this trial?

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.

Research Team

Fadel Zeidan, PhD

Principal Investigator

UC San Diego

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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 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]

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]

References

1. United States 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. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Enhanced anandamide plasma levels in patients with complex regional pain syndrome following traumatic injury: a preliminary report. [2016]

3. United States 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. [2021]

4. United States 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. [2022]

5. Switzerland 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. [2023]

6. New Zealand 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. [2020]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Dose-Related Inhibition of Capsaicin Responses by Cannabinoids CBG, CBD, THC and their Combination in Cultured Sensory Neurons. [2022]