Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia

This single-group, open-label trial evaluates the safety and efficacy of two oral psilocybin doses administered two weeks apart alongside psychotherapy in adults meeting 2016 fibromyalgia survey criteria.

Primary assessments focus on change in chronic pain symptoms and related domains; safety is monitored via adverse events, ECG, and clinical interviews. Psychotherapy includes preparatory, dosing-day support, and post-dose integration sessions.