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

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · May 15, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a substance called psilocybin, which comes from certain mushrooms, to help women who suffer from chronic pelvic pain (CPP) that hasn't improved with standard treatments. The study aims to enroll 15 women between the ages of 18 and 45 who have been diagnosed with CPP for at least six months. Participants should have tried at least one treatment for their pain without success. The trial will include psychotherapy sessions to support the treatment, which involves taking a single moderate dose of psilocybin.

To be eligible, women must have specific types of chronic pelvic pain, like endometriosis or pelvic inflammatory diseases, and they should generally be in good health. However, women with certain conditions—like severe mental health issues or those currently using specific drugs—will not be able to participate. If you join the study, you can expect two preparation sessions before taking the psilocybin and three follow-up sessions to discuss how the treatment is affecting you. This trial is still in the planning stages, so it has not started recruiting participants yet.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Assigned female at birth, age 18-45 years (pre-menopause)
• • CPP for at least 6 months or longer with central sensitization, diagnosed by a provider who specializes in CPP (e.g. MD, DO, NP)
• • CPP with central sensitization includes endometriosis, adenomyosis, uterine fibroids, pelvic congestion, other pelvic inflammatory diseases, irritable bowel syndrome, inflammatory bladder disorders, myalgias, or any combination of the aforementioned1,3
• • Failing at least 1 treatment for CPP. Failed conventional interventions include pharmacotherapy, non-pharmacotherapy (bladder installations, neuromodulation, trigger point injections, anesthetic blocks, surgery), physical therapy, and/or psychotherapy (e.g. Cognitive Behavioral Therapy)
• • Participants will be generally healthy with no exclusionary physical or mental health conditions.
• Exclusion Criteria:
• • Pelvic pain that is not defined as chronic (e.g. acute pelvic or vaginal infections such as sexually transmitted infections, urinary tract infections, pregnancy)
• • Have a history of or a current primary psychotic disorder or bipolar disorder type 1
• • Current use of lithium.
• • Ketamine-assisted therapy within 12 weeks of the baseline visit (V3) or hallucinogen use within 6 months of study enrollment (e.g. psilocybin at a dose of 10 mg or 1 gram mushroom or greater, LSD, MDMA, DMT)
• • Cannabis use (THC, CBD). If willing to taper before the baseline visit (V3) the participant can be included.
• • A positive urine drug test for illicit substance use
• • a score of 5 or greater on the Alcohol Use Disorder Identification Test- Consumption (AUDIT-C) indicating heavy alcohol use
• • Suicidal ideation or serious suicide risk as determined by C-SSRS, if baseline score is 4 or greater.
• • Uncontrolled hypertension, cardiovascular disease, chronic neurologic disorders (e.g. Parkinson's disease, dementia, multiple sclerosis, epilepsy)
• • Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation