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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2026 → Dec 31, 2027
See other at-risk trials from Oregon Health and Science University

Record History

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  1. Recruitment opened Show 4 more changesShow less
    • Start date: Oct 1, 2026 to Nov 1, 2026
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 10 of 14 entries
    • Site details revised
  2. Primary and study completion pushed from Dec 31, 2026 to Dec 31, 2027
    • Start date: Jan 1, 2026 to Oct 1, 2026
    • Site contact updated
    v3
  3. Primary completion date: May 30, 2026 to Dec 31, 2026
    • Start date: Aug 1, 2025 to Jan 1, 2026
    • Study sites: 0 to 1
    • Study completion date: Jul 31, 2026 to Dec 31, 2026
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06988319
Lead Sponsor Oregon Health and Science University
Collaborators: Portland Psychotherapy Clinic, Research, and Training Center
Conditions
(from sponsor)		 Chronic Pelvic Pain
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov