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

Description

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.

Conditions

Complex Regional Pain Syndrome

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Complex Regional Pain Syndrome
Intervention / Treatment

-

Contacts and Locations

La Jolla

Altman Clinical and Translational Research Institute, La Jolla, California, United States, 92093

San Diego

University of California, San Diego, San Diego, California, United States, 92093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

21 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Diego,

Fadel Zeidan, PhD, PRINCIPAL_INVESTIGATOR, UC San Diego

Study Record Dates

2029-06-01