Phase 1: testing Psilocybin (Usona Institute) for Chronic Pelvic Pain
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).
Official registry: https://clinicaltrials.gov/study/NCT06988319 · Oregon Health and Science University · enrollment listed as 15
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Psilocybin (Usona Institute). The registry lists allocation as na. 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).
They plan to enroll about 15 people at Portland. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study
Interventions: Psilocybin (Usona Institute)
Primary outcome (registry wording): Recruitment and Retention Feasibility
Who it is for (from inclusion criteria)
- Ages 18 Years to 45 Years
- Women only
- 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
- you would be generally healthy with no exclusionary physical or mental health conditions
Who the registry excludes
- 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
Public study contact (from the registry)
Lynne H Shinto, ND, MPH
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Oregon Health & Science University — Portland, Oregon (recruiting)
FAQ about this NCT record
Is NCT06988319 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06988319?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06988319?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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