Psilocybin for Chronic Pelvic Pain in Women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, interventional pilot feasibility study aiming to enroll 15 women with chronic pelvic pain who have failed prior therapies. Participants receive a single 25 mg dose of pharmaceutical-grade psilocybin alongside structured psychotherapy sessions (two pre-dose and three post-dose integration sessions) to explore safety and feasibility. The study addresses central sensitization as a key mechanism in CPP and seeks to determine whether this psychedelic-assisted approach can alter pain perception and related quality of life. No efficacy conclusions are intended at this stage, but safety data will be collected to inform future research. The investigation is conducted at Oregon Health & Science University with collaboration from the Portland Psychotherapy Clinic, Research, and Training Center.

Why it matters

Who can join: the full rules

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

Where it's running

• Oregon Health & Science University
  Portland, Oregon, United States Recruiting

Study contacts

• Study coordinator: Lynne H Shinto, ND, MPH
• Email: shintol@ohsu.edu
• Phone: (503) 494-5035

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• How bladder microbes and immune signals affect lower urinary tract health

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.