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

NCT06988319 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: 28634Circle of Giving Foundation
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Pelvic Pain

Keywords

psilocybin; women; chronic pelvic pain; psilocybin assisted therapy

Outcome Measures

Primary Outcomes (3)

• Recruitment and Retention Feasibility

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

  baseline to 1-month post psilocybin dose

• Acceptability

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

  End-of-Study Visit at 1-month post psilocybin dose

• Number of participants with treatment related adverse events

  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

  From enrollment to 1-month post treatment

Secondary Outcomes (14)

• Patient-Reported Outcome Measurement Information System (PROMIS) Pain interference Inventory

  From enrollment to 1-month post treatment

• Central Sensitization Questionnaire

  From enrollment to 1-month post treatment

• Revised Mystical Experience Questionnaire (MEQ 30)

  24-48 hours post psilocybin dose

• Challenging Experience Questionnaire

  24-48 hours post psilocybin dose

• Modified Differential Emotions Scale (mDES) Questionnaire

  From enrollment to 1-month post treatment

Other Outcomes (1)

• Columbia-Suicide Severity Rating Scale

  From enrollment to 1-month post treatment

Study Arms (1)

Single dose psilocybin (25 mg)

EXPERIMENTAL

Single dose of pharmaceutical grade psilocybin (25 mg) with psychotherapy

Drug: Psilocybin (Usona Institute)

Interventions

Psilocybin (Usona Institute) DRUG

Single dose of pharmaceutical grade psilocybin (25 mg) combined with psychotherapy sessions

Single dose psilocybin (25 mg)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Chronic pelvic pain in women that include some gender specific conditions (e.g. endometriosis)
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Portland Psychotherapy Clinic, Research, and Training Center: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Interventions

Psilocybin

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Central Study Contacts

Lynne H Shinto, ND, MPH

CONTACT

(503) 494-5035; shintol@ohsu.edu

Jacquelyn Knapp, MD

CONTACT

(510) 299-7662; knapja@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Model Details: 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

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 23, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)