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Psilocybin for Chronic Pelvic Pain in Women

This pilot study is looking at whether a single dose of psilocybin (from Usona Institute), combined with psychotherapy, is a practical and safe approach for women with chronic pelvic pain (CPP). CPP is ongoing pain in the pelvic area that has lasted for at least six months. The study aims to enroll 15 women, aged 18-45, who have CPP with central sensitization (a heightened sensitivity to pain). Researchers want to see how easy it is to recruit and keep participants, how acceptable the treatment is, and if there are any side effects. This study is not yet recruiting, so its status is unclear.

Study design
This is an interventional study planning to enroll 15 women. It will test a single dose of psilocybin combined with psychotherapy.
What's involved
You would receive a single dose of psilocybin and participate in two psychotherapy sessions before the dose and three after. Your participation would be measured from baseline to one month after the psilocybin dose.
Compensation
Not stated in the trial record.
Follow-up
Your safety and acceptability of the treatment will be monitored until one month after the psilocybin dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06988319

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

Not Yet Recruiting
PHASE1Ages 18–45InterventionalTreatment
Oregon Health and Science University
~15 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Psilocybin (Usona Institute)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment and Retention Feasibility
Measured over baseline to 1-month post psilocybin dose
+2 more outcomes measured

Conditions

Chronic Pelvic Pain

Explore related trials

Pelvic Pain

Where it's being run

1 sites across 1 states
Oregon1

Who to contact

Lynne H Shinto, ND, MPH
[email protected]
(503) 494-5035
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Recruitment and Retention Feasibilitybaseline to 1-month post psilocybin dose

    Proportion of eligible participants who complete the study from baseline to 1 month post psilocybin dose

  • AcceptabilityEnd-of-Study Visit at 1-month post psilocybin dose

    Acceptability will use qualitative data collection to provide information on the benefits and challenges of the intervention using a semi-structured interview.

  • Number of participants with treatment related adverse eventsFrom enrollment to 1-month post treatment

    Adverse events will be collected using a 12- item adverse events checklist covering all major organ systems will be included to probe for adverse events. The nature of each AE, its severity (mild, moderate, or severe), its likely relationship to study treatment (definite, probable, possible, not related, or unknown), its duration and any necessary treatment modifications or adjustments will be recorded. In addition to recording of AEs,, and labs to assess basic metabolic function (including liver function tests), a complete blood count