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CBD drug shows promise for stubborn heart pain

NCT ID NCT05494788

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a pure cannabidiol (CBD) solution called CardiolRx in 27 adults with recurrent pericarditis, a condition causing repeated inflammation and pain around the heart. Participants had not responded well to standard treatments or needed long-term steroids. The goal was to see if CardiolRx is safe and can help reduce pain and inflammation, and possibly allow patients to stop other medications. It was a small pilot study, so results are preliminary.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CardiolRx (pharmaceutically produced cannabidiol, a CBD oral solution)
What this could lead to
If this works, it could offer a new option to reduce pain and inflammation for people with recurrent pericarditis who don't respond to standard treatments.
What could go wrong
This is a small, early pilot study with only 27 participants, so results may not apply widely. It tested safety and symptom changes, not long-term effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

27 people

The number who actually took part.

Started

Jan 2023

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female 18 years of age or older 2. Diagnosis of at least two episodes of recurrent pericarditis\*, 3. At least 1 day with pericarditis pain ≥4 on the 11-point Numerical Rating Scale (NRS) within prior 7 days 4. One of; 1. C-Reactive Protein\*\* (CRP) level ≥1.0 mg/dL within prior 7 days OR 2. Evidence of pericardial inflammation assessed by delayed pericardial hyperenhancement on cardiac magnetic resonance imaging (CMR) 5. Currently receiving non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine and/or corticosteroids (in any combination) for treatment of pericarditis in stable doses 6. Male patients with partners of childbearing potential who have had a vasectomy or are willing to use double barrier contraception methods during the conduct of the study and for 2 months after the last dose of study drug. 7. Women of childbearing potential willing to use an acceptable method of contraception starting with study drug administration and for a minimum of 2 months after study completion. Otherwise, women must be postmenopausal (at least 1 y absence of vaginal bleeding or spotting and confirmed by follicle stimulating hormone \[FSH\] ≥40 mIU/mL \[or ≥ 40 IU/L\] if less than 2 y postmenopausal) or be surgically sterile. * Diagnosis of pericarditis according to the 2015 European Society of Cardiology (ESC) Guidelines for the Diagnosis and Management of Pericardial Diseases (Adler et al. 2015): At least two of: 1. Pericarditic chest pain 2. Pericardial rub 3. New widespread ST-segment elevation or PR-segment depression according to electrocardiogram (ECG) findings 4. Pericardial effusion (new or worsening) * Conversion: 1 mg/dL CRP = 10 mg/L hs-CRP Exclusion Criteria: 1. Diagnosis of pericarditis that is secondary to specific prohibited etiologies, including tuberculosis (TB); neoplastic, purulent, or radiation etiologies; post-thoracic blunt trauma (e.g., motor vehicle accident); myocarditis 2. Estimated glomerular filtration rate (eGFR) \<30 mL/min at screening 3. Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal (ULN) or ALT or AST \>3x ULN plus bilirubin \>2x ULN 4. Sepsis, defined as documented bacteremia at the time of screening or other documented active infection 5. Prior history of sustained ventricular arrhythmia 6. History of QT interval prolongation 7. QTc interval \> 500 msec 8. Current participation in any research study involving investigational drugs or device 9. Inability or unwillingness to give informed consent 10. Ongoing drug or alcohol abuse 11. On any cannabinoid during the past month 12. Women who are pregnant or breastfeeding 13. Current diagnosis of cancer, with the exception of non-melanoma skin cancer 14. Any factor, which would make it unlikely that the patient can comply with the study procedures 15. Showing suicidal tendency as per the Columbia Suicide Severity Rating Scale (C-SSRS), administered at screening 16. On digoxin and/or type 1 or 3 antiarrhythmics 17. On immunosuppressive therapy with any of the following: 1. Rilonacept 2. Anakinra 3. Canakinumab 4. Methotrexate 5. Azathioprine 6. Cyclosporine 7. Intravenous immune globulin (IVIG)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • MedStar Health Research Institute

    Washington D.C., District of Columbia, 20010, United States

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

  • Pima Heart and Vascular Clinical Research

    Tucson, Arizona, 85719, United States

  • University of Vermont Medical Center

    Burlington, Vermont, 05401, United States

  • Virginia Commonwealth University Health

    Richmond, Virginia, 23298, United States

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