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

NCT ID
NCT06988319
Registry status
Recruiting
Study type
Interventional
Phase
Phase 1
Sponsor
Oregon Health and Science University
Conditions
Chronic Pelvic Pain

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 15 participants (Estimated).

What is being studied

  • Intervention: Alkaloids
  • Intervention: Heterocyclic Compounds
  • Intervention: Heterocyclic Compounds, 2-Ring
  • Intervention: Heterocyclic Compounds, Fused-Ring
  • Intervention: Indole Alkaloids
  • Intervention: Indoles
  • Intervention: Indolizidines
  • Intervention: Indolizines
  • Intervention: Psilocybin
  • Drug: Psilocybin (Usona Institute)
  • Intervention: Tryptamines

Who may be eligible

Ages
18 Years to 45 Years
Sex
Female
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Oregon, United States: 1

Sample of listed locations

  • Oregon Health & Science University — Portland, Oregon, 97239, United States — Recruiting

Study details

Start date
November 1, 2026
Primary completion date
December 31, 2027
Completion date
December 31, 2027
First posted
May 23, 2025
Collaborators
Portland Psychotherapy Clinic, Research, and Training Center

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06988319
Registry last updated
September 23, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT06988319 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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