NCT06988319

Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The primary aim is to determine the feasibility of enrolling and 15 women with chronic pelvic pain (CPP) that have failed one conventional for CPP to obtain preliminary safety data on a single administration of a moderate dose of pharmaceutical grade psilocybin (25 mg) in combination with psychotherapy sessions (two pre-dose preparatory and three post-dose integration sessions).

Detailed description

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.

Conditions

• Chronic Pelvic Pain

Interventions

Type	Name	Description
DRUG	Psilocybin (Usona Institute)	Single dose of pharmaceutical grade psilocybin (25 mg) combined with psychotherapy sessions

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-05-23
• Last updated: 2025-10-10

Locations

1 site across 1 country: United States