July 12, 2026Journal of the American Heart Association0 citationsOpen Access
View Full PaperEfficacy and Safety of Pharmaceutically Manufactured Cannabidiol in Recurrent Pericarditis: A Phase II Clinical Trial
Key Result
Pharmaceutically manufactured cannabidiol reduced the maximal numerical rating scale pain score from 5.8 at baseline to 2.1 at 8 weeks in patients with recurrent pericarditis.
Key Points
- This trial investigates the efficacy and safety of pharmaceutically manufactured cannabidiol in patients with recurrent pericarditis.
- Phase 2, open-label, multicenter trial
- Included adults with recurrent pericarditis and elevated C-reactive protein
- Cannabidiol treatment for 8 weeks with an optional 18-week extension.
- At Week 8, pain score decreased from 5.8±1.7 to 2.1±1.8 (p<0.001)
- C-reactive protein normalized in 80% of patients with baseline elevation
- 71% of patients remained free of recurrence during extension.
Structured PICO
Does pharmaceutically manufactured cannabidiol reduce patient-reported pericarditis pain in adult patients with symptomatic recurrent pericarditis?
P
Population
27 adult patients with symptomatic recurrent pericarditis on stable background therapy, treated with cannabidiol for 8 weeks with an optional 18-week extension.
I
Intervention
Pharmaceutically manufactured cannabidiol administered orally during an 8-week treatment period and an optional 18-week extension period when background therapy was tapered and discontinued.
O
Outcome
Change in patient-reported pericarditis painpatient reported
Pharmaceutically manufactured cannabidiol appears safe and is associated with reduced pain and systemic inflammation in patients with symptomatic recurrent pericarditis.
Abstract
BACKGROUND: Recurrent pericarditis may be mediated through inappropriate activation of the NACHT, leucine-rich repeat, and pyrin domain-containing protein 3 inflammasome. Pharmaceutically manufactured cannabidiol is an oral formulation that inhibits NACHT, leucine-rich repeat, and pyrin domain-containing protein 3 inflammasome activation and development of pericarditis in a preclinical model. METHODS: This Phase 2, open-label, multicenter trial included adult patients with symptomatic recurrent pericarditis: pericarditis chest pain ≥4 on an 11-point numerical rating scale with an elevated C-reactive protein (≥1 mg/dL) or at least mild pericardial inflammation on cardiac magnetic resonance imaging. At enrollment, patients were on stable doses of non-steroidal anti-inflammatory drugs, colchicine, and/or corticosteroids. Cannabidiol was administered during an 8-week treatment period and an optional 18-week extension period when background therapy was tapered and discontinued. The primary efficacy end point was change in patient-reported pericarditis pain. Secondary end points included normalization of C-reactive protein and percentage of patients with recurrences. RESULTS: Among 27 patients (18 women, mean age 53 years), baseline maximal numerical rating scale pain score was 5.8±1.7, and 10 patients had elevated C-reactive protein. At Week 8, maximal numerical rating scale pain score was 2.1±1.8, and median time to numerical rating scale score ≤2 was 5 days. Among the 10 patients with baseline C-reactive protein elevation, C-reactive protein was normal at Week 8 in 8 patients (80%). During the extension period, 17 (71%) of 24 patients remained free of pericarditis recurrence. A serious adverse event leading to cannabidiol discontinuation occurred in 1 patient. CONCLUSIONS: In symptomatic patients with recurrent pericarditis, pharmaceutically manufactured cannabidiol appears safe and associated with reductions in pericarditis pain and systemic inflammation. REGISTRATION: URL: clinicaltrials.gov; Unique Identifier: NCT05494788.
Expert Takes2 quotes
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“This is real, prospective Phase II data showing a measurable pain and CRP signal in recurrent pericarditis, not proof that CBD works, since there was no placebo arm and the sponsor funded the trial. It is a strong enough signal to justify the randomized Phase III trial now underway, and not yet strong enough to change first-line treatment.”