Effects of a high CBD cannabis extract on pain in Complex Regional Pain Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Non-invasive brain stimulation to see if it changes pain avoidance in CRPS

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• tDCS for CRPS: see if a non‑invasive brain stimulation helps reduce pain

  This trial tests whether transcranial direct current stimulation can lessen pain and improve mood and function for people with complex regional pain syndrome.

  Recruiting Polyclinique de l'Europe · Saint-Nazaire · NCT07361692

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.