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

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Apr 26, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a high CBD cannabis extract, called BRC-002, might help relieve pain and improve health in people with Complex Regional Pain Syndrome (CRPS). CRPS is a condition that causes ongoing pain, often in one limb, and can be very challenging to manage. The researchers want to learn if cannabinoids, which are compounds found in cannabis, can reduce pain and improve other related health issues. To do this, they will conduct various tests during the study to understand how this treatment works and its effects on participants.

To be eligible for this trial, participants need to be between 21 and 75 years old, able to communicate in English, and must have had CRPS for at least three months. They should not have any major health issues or previous negative experiences with cannabis, and they must not be using any cannabis products or certain medications during the study. The trial includes a pre-treatment period, a six-week treatment phase, and a two-week follow-up. Participants will receive comprehensive support and monitoring throughout the process. If you or someone you know is interested, this could be an opportunity to explore a new approach to managing CRPS pain.

Gender

ALL

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