Actively Recruiting
The Effects and Mechanisms of a High CBD Cannabis Extract (BRC-002) for the Treatment of Pain and Health in Complex Regional Pain Syndrome
Led by University of California, San Diego · Updated on 2024-06-07
52
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Effects and Mechanisms of a High CBD Cannabis Extract (BRC-002) for the Treatment of Pain and Health in Complex Regional Pain Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provision of signed and dated informed consent form
- Age between 21 and 75 years old
- Ability to communicate in English
- No previous medical history such as cardiac or pulmonary disease
- Not currently using any type of cannabis, including hemp or CBD
- Cannabis-free for at least 30 days before participation
- Diagnosed with ongoing CRPS (Type 1 or Type 2) for at least 3 months prior to participation, confirmed by medical records
- Agree not to use cannabis, hemp, or CBD outside of the study during participation
- Agree not to use opioids or barbiturates during participation
You will not qualify if you...
- Failing cannabis screening
- Active pulmonary disease
- Allergy or past adverse effects or negative experiences with cannabis
- Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone before study sessions
- Significant illnesses including cardiovascular disease, diabetes, renal or liver disease
- Current or past immunocompromising diseases or conditions such as lupus, psoriasis, multiple sclerosis
- Current or past neurological conditions including Parkinson's disease, dementia, cognitive impairment, seizure disorder, traumatic brain injury
- Current major psychiatric illnesses per DSM-V such as bipolar disorder, major depression, psychosis, substance use disorder, schizophrenia
- Current or past suicidal ideation or attempts
- Clinically significant laboratory abnormalities
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Altman Clinical and Translational Research Institute
La Jolla, California, United States, 92093
Actively Recruiting
2
University of California, San Diego
San Diego, California, United States, 92093
Actively Recruiting
Research Team
F
Fadel Zeidan, PhD
CONTACT
Y
Yasmeen Esshaki, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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