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NCT06988319 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Oregon Health and Science University.

Not yet
Registry status
Phase 1
Development phase
15
Enrollment target

NCT06988319: Clinical Trial Phase 1 study, sponsored by Oregon Health and Science University.

NCT06988319 is a Phase 1 study that has not yet begun recruiting, run by Oregon Health and Science University. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06988319, a Phase 1 study, has not yet begun recruiting, sponsored by Oregon Health and Science University.

NOT YET RECRUITING
Registry status
Phase 1
Development phase
15 participants
Enrollment target

Study 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).

Primary Outcome

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

Interventions

  • DRUG Psilocybin (Usona Institute)

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2026-01-01
Est. Completion 2026-12-31
Phase Phase 1

What is known before NCT06988319 opens enrollment

NCT06988319 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 1 intervention - of which Psilocybin (Usona Institute) is the first listed.

NCT06988319 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06988319 about?

NCT06988319 is a clinical study titled "Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study". 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 psychother...

What is the current status of trial NCT06988319?

This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2026-01-01. Estimated completion is 2026-12-31.

What interventions are being tested in trial NCT06988319?

The interventions under investigation include: Psilocybin (Usona Institute) (DRUG).

Who is sponsoring clinical trial NCT06988319?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06988319's enrollment target sits among peer trials

15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06988319, the US trial registry maintained by the National Library of Medicine. NCT06988319 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.