Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study
This open-label Phase I trial (n=15) will assess the feasibility and safety of a single 25 mg dose of pharmaceutical-grade psilocybin combined with psychotherapy in women aged 18–45 with chronic pelvic pain (CPP) who have not responded to at least one conventional treatment.
Detailed Description
Chronic pelvic pain (CPP) affects many women and is often associated with central sensitization and impaired quality of life. This pilot feasibility study will evaluate a single administration of 25 mg pharmaceutical-grade psilocybin combined with psychotherapy in women with CPP who have failed at least one conventional therapy.
Primary aims are feasibility (≥80% study completion and visit attendance) and preliminary safety assessed by adverse events, vital signs and laboratory tests; participants receive two preparatory sessions and three integration sessions surrounding the single dosing session.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
Psilocybin 25 mg
experimentalSingle dose of pharmaceutical-grade psilocybin (25 mg) with psychotherapy (preparatory + integration sessions).
Interventions
- Psilocybin25 mgvia Oral• single dose• 1 doses total
Usona Institute; pharmaceutical-grade psilocybin; combined with psychotherapy (2 pre-dose, 3 post-dose sessions).
Participants
Inclusion 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 aforementioned
- 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
- 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 Details
- StatusNot yet recruiting
- PhasePhase I
- Typeinterventional
- DesignNon-randomized
- Target Enrollment15 participants
- TimelineStart: 2025-08-01End: 2026-07-31
- Compound
- Topic