Clinical trial NCT06393101: The Effects and Mechanisms of a High CBD Cannabis Extract (BRC-002) for the Treatment of Pain and Health in Complex Regional Pain Syndrome
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Complex Regional Pain Syndrome
Keywords: Complex Regional Pain Syndrome
CRPS
Cannabis
Pain
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in complex regional pain syndrome pain and heat pain measured with VAS
timeFrame: Day 1 - Day 42
Secondary outcomes:
measure: Pain Inventory Measure
timeFrame: Day 1 - Day 42
measure: Depression Measure
timeFrame: Day 1 - Day 42
measure: Sleep Measure
timeFrame: Day 1 - Day 42
measure: Interleukin 6
timeFrame: Day 1 - Day 42
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Altman Clinical and Translational Research Institute
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: UC San Diego
name: Fadel Zeidan, PhD
role: PRINCIPAL_INVESTIGATOR
References: