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Cannabinoid

CBD Cannabis Extract for Complex Regional Pain Syndrome

Phase 1
Recruiting
Led By Fadel Zeidan, PhD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 21-75 years old
Not currently using any type of cannabis, including hemp or CBD
Must not have
Any current or history of an immunocompromising disease or condition (such as lupus, psoriasis, multiple sclerosis, etc.)
Active pulmonary disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 - day 42

Summary

This trial aims to study how cannabinoids can help relieve pain in complex regional pain syndrome (CRPS). They will use various tests to see how cannabinoids affect pain and inflammation in patients with CRPS. The

Who is the study for?
This trial is for individuals with Complex Regional Pain Syndrome (CRPS), a condition causing persistent severe pain. Participants should be experiencing CRPS-related pain and may have associated health issues like somatoform disorders. Details on specific inclusion or exclusion criteria are not provided, but typically these would outline who can safely participate based on factors like age, disease severity, and other medical conditions.
What is being tested?
The study is testing BRC-002, a high CBD cannabis extract, to see if it helps with CRPS pain and overall health. It involves comparing the effects of BRC-002 against a placebo over six weeks of treatment followed by two weeks of follow-up. The trial will also explore how cannabinoids might relieve pain through various physical and psychological tests along with inflammation marker assessments.
What are the potential side effects?
While specific side effects are not listed here, common side effects from high CBD products may include tiredness, diarrhea, changes in appetite/weight. Since this is an investigational product being tested in clinical trials, there could be additional unknown risks or side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 75 years old.
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I am not using any cannabis products, including hemp or CBD.
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I agree not to use cannabis, hemp, or CBD outside the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had an immune system disease like lupus or MS.
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I have a current lung condition.
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I have a serious illness such as heart disease, diabetes, or kidney/liver problems.
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I have no history of neurological conditions like Parkinson's, dementia, or brain injuries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 - day 42
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 - day 42 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in complex regional pain syndrome pain and heat pain measured with VAS
Secondary study objectives
Depression Measure
Interleukin 6
Pain Inventory Measure
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: ActiveExperimental Treatment1 Intervention
Drug: BRC-002 (High Cannabidiol Botanical Extract) 100 mg/mL
Group II: Placebo Comparator: 1 PlaceboPlacebo Group1 Intervention
Half of the patients will receive PO placebo

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,995 Total Patients Enrolled
Fadel Zeidan, PhDPrincipal InvestigatorUC San Diego
6 Previous Clinical Trials
308 Total Patients Enrolled
~35 spots leftby Jun 2029
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