RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-06-01
Study Completion:2029-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06393101

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.

Ages Eligible for Study:21 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form.
  2. 2. Are between 21-75 years old
  3. 3. Ability to communicate in English
  4. 4. Volunteers with no previous medical history (e.g., cardiac or pulmonary disease)
  5. 5. Are not currently using any type of cannabis, including hemp or CBD
  6. 6. Currently 30 days cannabis free
  7. 7. Participants with ongoing CRPS \[Type 1 or Type 2)\] for at least 3 months prior to participation (medical record confirmed)
  8. 8. Agrees not to use cannabis, including hemp or CBD, outside of the study during participation in the study
  9. 9. Agrees not to use opioids or barbiturates during participation in the study
  1. 1. Fail cannabis screening
  2. 2. Active pulmonary disease
  3. 3. Allergy or past adverse effects or negative past experiences from cannabis
  4. 4. Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone prior to study session 1 or session 2
  5. 5. Any significant illness, including cardiovascular disease, diabetes, renal and liver disease
  6. 6. Any current or history of an immunocompromising disease or condition (such as lupus, psoriasis, multiple sclerosis, etc.)
  7. 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. 8. Participant meets DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, psychosis, substance use disorder, or schizophrenia
  9. 9. Any current or history of suicidal ideation or attempt
  10. 10. Patients with clinically significant laboratory abnormalities

Contacts and Locations

Study Contact

Fadel Zeidan, PhD
CONTACT
858-246-8341
fzeidan@health.ucsd.edu
Yasmeen Esshaki, MS
CONTACT
858-246-8341
yesshaki@health.ucsd.edu

Principal Investigator

Fadel Zeidan, PhD
PRINCIPAL_INVESTIGATOR
UC San Diego

Study Locations (Sites)

Altman Clinical and Translational Research Institute
La Jolla, California, 92093
United States
University of California, San Diego
San Diego, California, 92093
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Fadel Zeidan, PhD, PRINCIPAL_INVESTIGATOR, UC San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-01
Study Completion Date2029-06-01

Study Record Updates

Study Start Date2024-06-01
Study Completion Date2029-06-01

Terms related to this study

Keywords Provided by Researchers

  • Complex Regional Pain Syndrome
  • CRPS
  • Cannabis
  • Pain

Additional Relevant MeSH Terms

  • Complex Regional Pain Syndrome