Effects of a high CBD cannabis extract on pain in Complex Regional Pain Syndrome
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effects and Mechanisms of a High CBD Cannabis Extract (BRC-002) for the Treatment of Pain and Health in Complex Regional Pain Syndrome
This study is testing whether a high CBD cannabis extract can help people with Complex Regional Pain Syndrome find relief from their pain.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 2 sites (La Jolla, California and 1 other locations) |
| Trial ID | NCT06393101 on ClinicalTrials.gov |
What this trial studies
This trial aims to explore the effects and mechanisms of a high CBD cannabis extract (BRC-002) on pain relief in individuals suffering from Complex Regional Pain Syndrome (CRPS). It employs multiple psychophysical assessments alongside psychological and inflammatory marker testing to evaluate how cannabinoids may lead to sustained improvements in pain and related symptoms. The study includes a pre-treatment screening phase, a six-week treatment period, and a two-week follow-up to monitor outcomes. Participants will be closely monitored to ensure compliance with cannabis abstinence during the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-75 with a confirmed diagnosis of CRPS for at least three months who have been cannabis-free for 30 days prior to participation.
Not a fit: Patients with active pulmonary disease or those who have had adverse reactions to cannabis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic option for managing pain in patients with Complex Regional Pain Syndrome.
How similar studies have performed: While the use of cannabinoids for pain management is being explored, this specific approach in CRPS is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
La Jolla, California and 1 other locations
- Altman Clinical and Translational Research Institute — La Jolla, California, United States (Recruiting)
- University of California, San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Fadel Zeidan, PhD — UC San Diego
- Study coordinator: Fadel Zeidan, PhD
- Email: fzeidan@health.ucsd.edu
- Phone: 858-246-8341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.