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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT06988319
Phase
PHASE1
Status
Recruiting
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Conditions

  • Chronic Pelvic Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin (Usona Institute) — DRUG
    Single dose of pharmaceutical grade psilocybin (25 mg) combined with psychotherapy sessions

Study Details

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).

Key Dates

First listed
May 23, 2025
Start date
Nov 1, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Recruitment and Retention Feasibility [ Time Frame: baseline to 1-month post psilocybin dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health & Science UniversityPortlandOregon97239
Lynne Shinto, ND, MPH
[email protected]
(503) 494-5035
Lynne Shinto, ND, MPH (PRINCIPAL_INVESTIGATOR)
Jacquelyn Knapp, MD (PRINCIPAL_INVESTIGATOR)

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Oregon Health & Science University· Portland, OR

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