Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study
This open-label Phase I trial (n=15) will assess the feasibility and safety of a single 25 mg dose of pharmaceutical-grade psilocybin combined with psychotherapy in women aged 18–45 with chronic pelvic pain (CPP) who have not responded to at least one conventional treatment.
Details
Chronic pelvic pain (CPP) affects many women and is often associated with central sensitization and impaired quality of life. This pilot feasibility study will evaluate a single administration of 25 mg pharmaceutical-grade psilocybin combined with psychotherapy in women with CPP who have failed at least one conventional therapy.
Primary aims are feasibility (≥80% study completion and visit attendance) and preliminary safety assessed by adverse events, vital signs and laboratory tests; participants receive two preparatory sessions and three integration sessions surrounding the single dosing session.