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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