Complex Regional Pain SyndromePhase 1NCT06393101
The Effects and Mechanisms of a High CBD Cannabis Extract (BRC-002) for the Treatment of Pain and Health in Complex Regional Pain Syndrome
A Phase 1 study testing BRC-002 in people with Complex Regional Pain Syndrome, run by University of California, San Diego at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Complex Regional Pain Syndrome
- What is being tested?
- BRC-002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2024to 1 Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Are between 21-75 years old
- Ability to communicate in English
- Volunteers with no previous medical history (e.g., cardiac or pulmonary disease)
- Are not currently using any type of cannabis, including hemp or CBD
- Currently 30 days cannabis free
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- Participants with ongoing CRPS [Type 1 or Type 2)] for at least 3 months prior to participation (medical record confirmed)
- Agrees not to use cannabis, including hemp or CBD, outside of the study during participation in the study
- Agrees not to use opioids or barbiturates during participation in the study
Who cannot join
- Fail cannabis screening
- Active pulmonary disease
- Allergy or past adverse effects or negative past experiences from cannabis
- Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone prior to study session 1 or session 2
- Any significant illness, including cardiovascular disease, diabetes, renal and liver disease
- Any current or history of an immunocompromising disease or condition (such as lupus, psoriasis, multiple sclerosis, etc.)
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- 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
- Participant meets DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, psychosis, substance use disorder, or schizophrenia
- Any current or history of suicidal ideation or attempt
- Patients with clinically significant laboratory abnormalities
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Altman Clinical and Translational Research Institute
La Jolla, California, 92093
Fadel Zeidan, PhD, 858-246-2028 ext. 62028, zeidanlab@ucsd.edu
Yasmeen Esshaki, MA, 858-246-2028 ext. 62028, yesshaki@health.ucsd.edu
- Recruiting
University of California, San Diego
San Diego, California, 92093
Fadel Zeidan, PhD, 858-246-2028 ext. 62028, fzeidan@health.ucsd.edu
About this study
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
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.
Read the 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.
- Conditions
- Complex Regional Pain Syndrome
- Being tested
- BRC-002, BRC-002 Placebo
- Keywords
- Complex Regional Pain Syndrome, CRPS, Cannabis, Pain
- Medical subject headings
- Complex Regional Pain Syndromes, Marijuana Abuse, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRC-002Drug
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 PlaceboDrug
Oral solution of mono-, di-, and triglycerides
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator: 1 Placebo | Placebo comparator | Half of the patients will receive PO placebo Receives: Drug: BRC-002 Placebo |
| Experimental: Active | Experimental | Drug: BRC-002 (High Cannabidiol Botanical Extract) 100 mg/mL Receives: Drug: BRC-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in complex regional pain syndrome pain and heat pain measured with VAS
Change from baseline in pain intensity and unpleasantness ratings using an 11-point Visual Analog Scale in response to heat and ongoing CRPS pain
Measured: Day 1 - Day 42
Secondary outcomes (4)
Pain Inventory Measure
Change from baseline in The Brief Pain Inventory
Measured: Day 1 - Day 42
Depression Measure
Change from baseline in Beck Depression
Measured: Day 1 - Day 42
Sleep Measure
Change from baseline in Pittsburgh Sleep Quality Index
Measured: Day 1 - Day 42
Interleukin 6
Change from baseline in Interleukin 6
Measured: Day 1 - Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadel Zeidan, University of California, San Diego
- Investigators
- Fadel Zeidan, PhD, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393101
- Sponsor's protocol ID
- 809767
- Status last verified
- Jun 2024
- First submitted
- 24 Apr 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06393101
- Acronym / sponsor ID
- 809767
- Conditions
- Complex Regional Pain Syndrome
- Keywords
- Complex Regional Pain Syndrome, CRPS, Cannabis, Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator: 1 Placebo | Placebo comparator | Drug: BRC-002 PlaceboHalf of the patients will receive PO placebo |
| Experimental: Active | Experimental | Drug: BRC-002Drug: BRC-002 (High Cannabidiol Botanical Extract) 100 mg/mL |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of signed and dated informed consent form.
- Are between 21-75 years old
- Ability to communicate in English
- Volunteers with no previous medical history (e.g., cardiac or pulmonary disease)
- Are not currently using any type of cannabis, including hemp or CBD
Key exclusion criteria (10 listed)
- Fail cannabis screening
- Active pulmonary disease
- Allergy or past adverse effects or negative past experiences from cannabis
- Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone prior to study session 1 or session 2
- Any significant illness, including cardiovascular disease, diabetes, renal and liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRC-002BRC-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. | Drug | Experimental: Active |
| BRC-002 PlaceboOral solution of mono-, di-, and triglycerides | Drug | Placebo Comparator: 1 Placebo |
Primary outcome
Change in complex regional pain syndrome pain and heat pain measured with VAS
Time frame: Day 1 - Day 42
Change from baseline in pain intensity and unpleasantness ratings using an 11-point Visual Analog Scale in response to heat and ongoing CRPS pain
4 secondary outcomes
Pain Inventory Measure
Time frame: Day 1 - Day 42
Depression Measure
Time frame: Day 1 - Day 42
Sleep Measure
Time frame: Day 1 - Day 42
Interleukin 6
Time frame: Day 1 - Day 42
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Complex Regional Pain Syndrome
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 3
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Complex Regional Pain Syndrome Type I
Recruiting
The Effectiveness of Conservative Treatment in Patients With Complex Regional Pain Syndrome.
CRPS (Complex Regional Pain Syndromes)
RecruitingPhase 3
Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1
Complex Regional Pain Syndrome Type I
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fadel Zeidan, PhD principal investigator
UC San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BRC-002 in people with Complex Regional Pain Syndrome, run by University of California, San Diego at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fadel Zeidan, PhD (858-246-8341, fzeidan@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in complex regional pain syndrome pain and heat pain measured with VAS (time frame: Day 1 - Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.