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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06393101
Phase
PHASE1
Status
Recruiting
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Conditions

  • Complex Regional Pain Syndrome

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BRC-002 — DRUG
    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 — DRUG
    Oral solution of mono-, di-, and triglycerides

Study Details

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.

Key Dates

Start date
Jun 1, 2024
Status verified
Jun 2024
Primary completion
Jun 1, 2029
Completion
Jun 1, 2029

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Altman Clinical and Translational Research InstituteLa JollaCalifornia92093
Fadel Zeidan, PhD
[email protected]
858-246-2028
Yasmeen Esshaki, MA
[email protected]
858-246-2028
University of California, San DiegoSan DiegoCalifornia92093
Fadel Zeidan, PhD
[email protected]
858-246-2028

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By research site
Altman Clinical and Translational Research Institute· La Jolla, CAUniversity of California, San Diego· San Diego, CA

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