Recruiting
Phase 1

Psilocybin with Psychotherapy

Sponsor:

Oregon Health and Science University

Code:

NCT06988319

Conditions

Chronic Pelvic Pain

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Psilocybin (Usona Institute)

Study Details

Brief 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).

Conditions

Chronic Pelvic Pain

Study ID

NCT06988319

Start date

Nov 1, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • Failing at least 1 treatment for CPP. Failed conventional interventions include pharmacotherapy, non-pharmacotherapy (bladder installations, neuromodulation, trigger point injections, anesthetic blocks, surgery), physical therapy, and/or psychotherapy (e.g. Cognitive Behavioral Therapy)
  • Participants will be generally healthy with no exclusionary physical or mental health conditions.

Exclusion Criteria:

  • 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
  • Suicidal ideation or serious suicide risk as determined by C-SSRS, if baseline score is 4 or greater.
  • Uncontrolled hypertension, cardiovascular disease, chronic neurologic disorders (e.g. Parkinson's disease, dementia, multiple sclerosis, epilepsy)
  • Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single dose psilocybin (25 mg)

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

Interventions

Psilocybin (Usona Institute)

Single dose of pharmaceutical grade psilocybin (25 mg) combined with psychotherapy sessions

Primary outcome measure

  • Recruitment and Retention Feasibility [ Time Frame: baseline to 1-month post psilocybin dose ]
  • Acceptability [ Time Frame: End-of-Study Visit at 1-month post psilocybin dose ]
  • Number of participants with treatment related adverse events [ Time Frame: From enrollment to 1-month post treatment ]

Central Contacts and Locations

Central contacts

Lynne H Shinto, ND, MPH

(503) 494-5035shintol@ohsu.edu

Jacquelyn Knapp, MD

(510) 299-7662knapja@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Lynne Shinto, ND, MPH

(503) 494-5035shintol@ohsu.edu

Principal Investigator:

Lynne Shinto, ND, MPH

More Information

Sponsor

Oregon Health and Science University

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Keywords

  • psilocybin
  • women
  • chronic pelvic pain
  • psilocybin assisted therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.