Clinical trial NCT06988319: Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study
Official title: Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Chronic Pelvic Pain
Keywords: psilocybin
women
chronic pelvic pain
psilocybin assisted therapy
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Portland Psychotherapy Clinic, Research, and Training Center
First posted: 2025-05-23
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility and Acceptability study to assess safety of a single dose of pharmaceutical grade psilocybin at 25 mg combined with psychotherapy in women with chronic pelvic pain
Primary purpose: TREATMENT

Brief summary: The primary aim is to determine the feasibility of enrolling and 15 women with chronic pelvic pain (CPP) that have failed one conventional for CPP to obtain preliminary safety data on a single administration of a moderate dose of pharmaceutical grade psilocybin (25 mg) in combination with psychotherapy sessions (two pre-dose preparatory and three post-dose integration sessions).

Detailed description: Chronic pelvic pain (CPP) presents a significant challenge in healthcare, affecting approximately 15% of women in the United States and incurring annual healthcare costs upwards of $5.8 billion. This condition extends beyond persistent physical discomfort, profoundly impacting mental health and overall quality of life. Central to many chronic pain syndromes, CPP can lead to a heightened state of pain sensitivity known as central sensitization. This condition arises from neuroplastic changes within the central nervous system, leading to structural, functional, and chemical alterations in the brain that enhance neural reactivity, even in the absence of actual physical injuries. Central sensitization is characterized by widespread, multisite hyperalgesia and allodynia. These changes often co-occur with fatigue, mood and cognitive disturbances, sleep disruptions, and multisensory hypersensitivity, complicating the clinical picture and exacerbating the condition's impact on daily functioning.

The use of psilocybin in chronic pain is a paradigm shift from conventional pain therapy where the goal is pain alleviation, to changing a person's relationship with pain, offering a re-alignment or 'reset' of one's view of their pain, this is an innovative approach. To date, there are no psilocybin studies evaluating CPP.

This is a pilot feasibility and safety study to evaluate a single administration of psilocybin (25 mg) in women with CPP who have failed at least one conventional CPP therapy. The study will enroll 15 women, the primary aim is to assess feasibility that will be met when at least 80% of participants complete the study and attend 80% of 11 study visits (9/11 visits). Safety will be assessed by adverse event reports, safety labs, and vitals assessments.

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

Primary outcomes:
measure: Recruitment and Retention Feasibility
timeFrame: baseline to 1-month post psilocybin dose
measure: Acceptability
timeFrame: End-of-Study Visit at 1-month post psilocybin dose
measure: Number of participants with treatment related adverse events
timeFrame: From enrollment to 1-month post treatment
Secondary outcomes:
measure: Patient-Reported Outcome Measurement Information System (PROMIS) Pain interference Inventory
timeFrame: From enrollment to 1-month post treatment
measure: Central Sensitization Questionnaire
timeFrame: From enrollment to 1-month post treatment
measure: Revised Mystical Experience Questionnaire (MEQ 30)
timeFrame: 24-48 hours post psilocybin dose
measure: Challenging Experience Questionnaire
timeFrame: 24-48 hours post psilocybin dose
measure: Modified Differential Emotions Scale (mDES) Questionnaire
timeFrame: From enrollment to 1-month post treatment
measure: Reactions to Touch Questionnaire
timeFrame: 24-48 hours post psilocybin dose
measure: PTSD Checklist for DSM-5 Questionnaire
timeFrame: From enrollment to 1-month post treatment
measure: Female Sexual Function Questionnaire
timeFrame: From enrollment to 1-month post treatment
measure: Expectancy Visual Analogue Scale
timeFrame: Baseline visit
measure: Beck Depression Inventory II
timeFrame: From enrollment to 1-month post treatment
measure: Beck Anxiety Inventory
timeFrame: From enrollment to 1-month post treatment
measure: Self-Compassion Scale - Short Form
timeFrame: From enrollment to 1-month post treatment
measure: Snaith-Hamilton Pleasure Scale
timeFrame: From enrollment to 1-month post treatment
measure: CompACT-15
timeFrame: From enrollment to 1-month post treatment
Other outcomes:
measure: Columbia-Suicide Severity Rating Scale
timeFrame: From enrollment to 1-month post treatment
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Study officials:
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