Status:
NOT_YET_RECRUITING
Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Portland Psychotherapy Clinic, Research, and Training Center
Conditions:
Chronic Pelvic Pain
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
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 adminis...
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 ...
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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06988319
Start Date
January 1 2026
End Date
December 31 2026
Last Update
October 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Oregon Health & Science University
Portland, Oregon, United States, 97239