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Cannabinoid

Experimental: Active for Complex Regional Pain Syndrome

Q: Are there any age restrictions for potential participants in this clinical trial, specifically with regards to individuals over the age of 35?

To qualify for participation in this research, individuals must be between 21 and 75 years old.

Q: What is the current size of the study population participating in this clinical trial?

Yes, data from clinicaltrials.gov confirms that this research study is actively seeking volunteers. The trial was first posted on June 1st, 2024 and had its latest update on April 26th, 2024. In total, the study aims to recruit 52 participants across two designated sites.

Q: Are potential participants currently being accepted for this ongoing medical study?

According to details on clinicaltrials.gov, this research study is actively enrolling participants. The trial was initially listed on June 1st, 2024 and the most recent update occurred on April 26th, 2024.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 - day 42

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 - day 42

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in complex regional pain syndrome pain and heat pain measured with VAS

Secondary outcome measures

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,130 Previous Clinical Trials

1,552,804 Total Patients Enrolled

Fadel Zeidan, PhDPrincipal InvestigatorUC San Diego

6 Previous Clinical Trials

308 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any age restrictions for potential participants in this clinical trial, specifically with regards to individuals over the age of 35?

"To qualify for participation in this research, individuals must be between 21 and 75 years old."

Answered by AI

What is the current size of the study population participating in this clinical trial?

"Yes, data from clinicaltrials.gov confirms that this research study is actively seeking volunteers. The trial was first posted on June 1st, 2024 and had its latest update on April 26th, 2024. In total, the study aims to recruit 52 participants across two designated sites."

Answered by AI

Are potential participants currently being accepted for this ongoing medical study?

"According to details on clinicaltrials.gov, this research study is actively enrolling participants. The trial was initially listed on June 1st, 2024 and the most recent update occurred on April 26th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Fadel Zeidan 2024. "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. https://clinicaltrials.gov/ct2/show/NCT06393101.

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