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
- Not Yet 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) — DRUGSingle 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
- Start date
- Jan 1, 2026
- Status verified
- Oct 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
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
- Lynne H Shinto, ND, MPH(503) 494-5035
- Jacquelyn Knapp, MD(510) 299-7662
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | Lynne Shinto, ND, MPH (PRINCIPAL_INVESTIGATOR) Jacquelyn Knapp, MD (PRINCIPAL_INVESTIGATOR) |
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