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

Last updated: June 5, 2024
Sponsor: University of California, San Diego
Overall Status: Active - Recruiting

Phase

1

Condition

Reflex Sympathetic Dystrophy Syndrome (Rsds)

Somatoform And Dissociative Disorders

Neuropathy

Treatment

BRC-002 Placebo

BRC-002

Clinical Study ID

NCT06393101
809767
  • Ages 21-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 toparticipation (medical record confirmed)

  8. Agrees not to use cannabis, including hemp or CBD, outside of the study duringparticipation in the study

  9. Agrees not to use opioids or barbiturates during participation in the study

Exclusion

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 methadoneprior to study session 1 or session 2

  5. Any significant illness, including cardiovascular disease, diabetes, renal and liverdisease

  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 oftraumatic brain injury/head injury

  8. Participant meets DSM-V criteria for current major psychiatric illness, such asbipolar disorder, major depression, psychosis, substance use disorder, orschizophrenia

  9. Any current or history of suicidal ideation or attempt

  10. Patients with clinically significant laboratory abnormalities

Study Design

Total Participants: 52
Treatment Group(s): 2
Primary Treatment: BRC-002 Placebo
Phase: 1
Study Start date:
June 01, 2024
Estimated Completion Date:
June 01, 2029

Study Description

Complex Regional Pain Syndrome (CRPS) is a debilitating and perplexing chronic pain condition that produces incalculable suffering to millions of individuals worldwide. The enigmatic nature of CRPS has left it difficult to treat. CRPS is characterized by a constellation of pain, sensory, autonomic, and motor symptoms that is difficult to pinpoint the source of injury/inflammation. Although unclear, a common cause of CRPS are radial fractures that demonstrate aberrant processing 4-6 weeks after injury.

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.

Connect with a study center

  • Altman Clinical and Translational Research Institute

    La Jolla, California 92093
    United States

    Active - Recruiting

  • University of California, San Diego

    San Diego, California 92093
    United States

    Active - Recruiting

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