Magic mushroom compound could ease pelvic pain in women
NCT ID NCT06988319
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times
Summary
This early-stage study will test whether a single dose of psilocybin (25 mg) combined with therapy sessions is safe and feasible for women aged 18-45 with chronic pelvic pain that hasn't improved with standard treatments. The study involves 15 participants and focuses on recruitment, safety, and pain's impact on daily life. It is not a cure but aims to ease symptoms and improve quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Oregon Health & Science University
Portland, Oregon, 97239, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can culturally adapted physiotherapy ease chronic pelvic pain?
- Can a Nerve-Pain drug quiet chronic pelvic pain?
- Can a Two-Hour class rewire how women feel chronic pelvic pain?
- Can AI personalize exercise to ease pelvic pain?
- Light therapy for pelvic pain: a 1,000-Patient registry seeks answers