The Effects and Mechanisms of a High CBD Cannabis Extract (BRC-002) for the Treatment of Pain and Health in Complex Regional Pain Syndrome
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Complex Regional Pain Syndrome
In brief
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.
Key facts
- Study ID
- NCT06393101
- Run by
- University of California, San Diego
- People needed
- 52
- Starts
- 2024-06-01
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2024-06-07
Who can join
Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Provision of signed and dated informed consent form.
- Are between 21-75 years old
- Ability to communicate in English
- Volunteers with no previous medical history (e.g., cardiac or pulmonary disease)
- Are not currently using any type of cannabis, including hemp or CBD
- Currently 30 days cannabis free
- Participants with ongoing CRPS [Type 1 or Type 2)] for at least 3 months prior to participation (medical record confirmed)
- Agrees not to use cannabis, including hemp or CBD, outside of the study during participation in the study
- Agrees not to use opioids or barbiturates during participation in the study
You may not qualify if…
- Fail cannabis screening
- Active pulmonary disease
- Allergy or past adverse effects or negative past experiences from cannabis
- Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone prior to study session 1 or session 2
- Any significant illness, including cardiovascular disease, diabetes, renal and liver disease
- Any current or history of an immunocompromising disease or condition (such as lupus, psoriasis, multiple sclerosis, etc.)
- 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
- Participant meets DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, psychosis, substance use disorder, or schizophrenia
- Any current or history of suicidal ideation or attempt
- Patients with clinically significant laboratory abnormalities
Where it is running
- Altman Clinical and Translational Research Institute — La Jolla, California, United States (enrolling)
- University of California, San Diego — San Diego, California, United States (enrolling)
Full record on ClinicalTrials.gov
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