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 psilocybin combined with psychotherapy in women aged 18–45 with chronic pelvic pain (CPP) who have not responded to at least one conventional treatment.

The study, conducted by Oregon Health and Science University and led by Dr. Lynne Shinto, aims to explore a novel approach to managing CPP by targeting the psychological and neurological underpinnings of pain perception. CPP, often associated with central sensitisation (a condition where the central nervous system becomes hypersensitive to pain), affects around 15% of women in the U.S. and is commonly linked to conditions such as endometriosis, fibromyalgia, and irritable bowel syndrome.

Participants will receive preparatory psychotherapy prior to dosing and follow-up integration sessions after the psilocybin session. Researchers hope to determine whether participants can safely complete the full course of treatment and evaluate acceptability and early effects on pain, mood, and quality of life. The trial, supported in part by the Circle of Giving Foundation, is expected to run from August 2025 to July 2026.

Trial Details

Chronic pelvic pain (CPP) presents a significant challenge in healthcare, affecting approximately 15% of women in the United States and incurring annual healthcare costs upwards of $5.8 billion. This condition extends beyond persistent physical discomfort, profoundly impacting mental health and overall quality of life. Central to many chronic pain syndromes, CPP can lead to a heightened state of pain sensitivity known as central sensitization. This condition arises from neuroplastic changes within the central nervous system, leading to structural, functional, and chemical alterations in the brain that enhance neural reactivity, even in the absence of actual physical injuries. Central sensitization is characterized by widespread, multisite hyperalgesia and allodynia. These changes often co-occur with fatigue, mood and cognitive disturbances, sleep disruptions, and multisensory hypersensitivity, complicating the clinical picture and exacerbating the condition's impact on daily functioning. The use of psilocybin in chronic pain is a paradigm shift from conventional pain therapy where the goal is pain alleviation, to changing a person's relationship with pain, offering a re-alignment or 'reset' of one's view of their pain, this is an innovative approach. To date, there are no psilocybin studies evaluating CPP. This is a pilot feasibility and safety study to evaluate a single administration of psilocybin (25 mg) in women with CPP who have failed at least one conventional CPP therapy. The study will enroll 15 women, the primary aim is to assess feasibility that will be met when at least 80% of participants complete the study and attend 80% of 11 study visits (9/11 visits). Safety will be assessed by adverse event reports, safety labs, and vitals assessments.

Trial Number NCT06988319

Data attribution

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