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
University of California, San Diego
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.
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-in…
Eligibility
- Age range
- 21–75 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugBRC-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.
- DrugBRC-002 Placebo
Oral solution of mono-, di-, and triglycerides
Locations (2)
- Altman Clinical and Translational Research InstituteLa Jolla, California
- University of California, San DiegoSan Diego, California