Recruiting
Phase 1

BRC-002

Sponsor:

UCLA

Code:

NCT06393101

Conditions

Complex Regional Pain Syndrome

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

BRC-002

BRC-002 Placebo

Study Details

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.

Conditions

Complex Regional Pain Syndrome

Study ID

NCT06393101

Start date

Jun 1, 2024

Status verified date

Jun, 2024

Completion date

Jun 1, 2029

Anticipated

Primary completion date

Jun 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo Comparator: 1 Placebo

Half of the patients will receive PO placebo

experimental: Experimental: Active

Drug: BRC-002 (High Cannabidiol Botanical Extract) 100 mg/mL

Interventions

BRC-002

BRC-002 is a non-scheduled cannabidiolic (CBD) formulation (<.3% THC). The cannabinoids in BRC-002 are naturally biosynthesized within the Cannabis sativa L. plant as acidic forms of CBD (cannabidiolic acid; CBDA), THC (tetrahydrocannabinolic acid; THCA) and other minor cannabinoids.

BRC-002 Placebo

Oral solution of mono-, di-, and triglycerides

Primary outcome measure

  • Change in complex regional pain syndrome pain and heat pain measured with VAS [ Time Frame: Day 1 - Day 42 ]

Central Contacts and Locations

Central contacts

Locations

Altman Clinical and Translational Research Institute

Recruiting

La Jolla, California, United States, 92093

Contacts

University of California, San Diego

Recruiting

San Diego, California, United States, 92093

Contacts

More Information

Sponsor

University of California, San Diego

Last update posted

Jun 7, 2024

Last verified

Jun, 2024

Keywords

  • Complex Regional Pain Syndrome
  • CRPS
  • Cannabis
  • Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2024-06-07.