Chronic Pelvic PainPhase 1NCT06988319
Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study
A Phase 1 study testing Psilocybin (Usona Institute) in people with Chronic Pelvic Pain, run by Oregon Health and Science University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Chronic Pelvic Pain
- What is being tested?
- Psilocybin (Usona Institute)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Lynne Shinto, ND, MPH, (503) 494-5035, shintol@ohsu.edu
Lynne Shinto, ND, MPH
About this 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 psychotherapy sessions (two pre-dose preparatory and three post-dose integration sessions).
Read the detailed description
Chronic pelvic pain (CPP) presents a significant challenge in healthcare, affecting approximately 15% of women in the United States and incurring annual healthcare costs upwards of $5.8 billion. This condition extends beyond persistent physical discomfort, profoundly impacting mental health and overall quality of life. Central to many chronic pain syndromes, CPP can lead to a heightened state of pain sensitivity known as central sensitization. This condition arises from neuroplastic changes within the central nervous system, leading to structural, functional, and chemical alterations in the brain that enhance neural reactivity, even in the absence of actual physical injuries. Central sensitization is characterized by widespread, multisite hyperalgesia and allodynia. These changes often co-occur with fatigue, mood and cognitive disturbances, sleep disruptions, and multisensory hypersensitivity, complicating the clinical picture and exacerbating the condition's impact on daily functioning.
The use of psilocybin in chronic pain is a paradigm shift from conventional pain therapy where the goal is pain alleviation, to changing a person's relationship with pain, offering a re-alignment or 'reset' of one's view of their pain, this is an innovative approach. To date, there are no psilocybin studies evaluating CPP.
This is a pilot feasibility and safety study to evaluate a single administration of psilocybin (25 mg) in women with CPP who have failed at least one conventional CPP therapy. The study will enroll 15 women, the primary aim is to assess feasibility that will be met when at least 80% of participants complete the study and attend 80% of 11 study visits (9/11 visits). Safety will be assessed by adverse event reports, safety labs, and vitals assessments.
- Conditions
- Chronic Pelvic Pain
- Being tested
- Psilocybin (Usona Institute)
- Keywords
- psilocybin, women, chronic pelvic pain, psilocybin assisted therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin (Usona Institute)Drug
Single dose of pharmaceutical grade psilocybin (25 mg) combined with psychotherapy sessions
| Study group | Role | What they receive |
|---|---|---|
| Single dose psilocybin (25 mg) | Experimental | Single dose of pharmaceutical grade psilocybin (25 mg) with psychotherapy Receives: Drug: Psilocybin (Usona Institute) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and Retention Feasibility
Proportion of eligible participants who complete the study from baseline to 1 month post psilocybin dose
Measured: baseline to 1-month post psilocybin dose
Acceptability
Acceptability will use qualitative data collection to provide information on the benefits and challenges of the intervention using a semi-structured interview.
Measured: End-of-Study Visit at 1-month post psilocybin dose
Number of participants with treatment related adverse events
Adverse events will be collected using a 12- item adverse events checklist covering all major organ systems will be included to probe for adverse events. The nature of each AE, its severity (mild, moderate, or severe), its likely relationship to study treatment (definite, probable, possible, not related, or unknown), its duration and any necessary treatment modifications or adjustments will be recorded. In addition to recording of AEs,, and labs to assess basic metabolic function (including liver function tests), a complete blood count
Measured: From enrollment to 1-month post treatment
Secondary outcomes (14)
Patient-Reported Outcome Measurement Information System (PROMIS) Pain interference Inventory
Provides a rating on pain's impact on physical, emotional, and social functioning, enjoyment, and quality of life.
Measured: From enrollment to 1-month post treatment
Central Sensitization Questionnaire
Provides a rating to assess symptoms associated with central sensitization (CS) and related conditions. The inventory is divided in two parts: Part A consists of 25 symptoms rated on a Likert scale from 0 (never) to 3 (often), with a total score ranging from 0 to 100, where scores 40 and higher are considered clinically relevant and indicative of a higher degree of CS. Part B screens for prior diagnoses of conditions related to CS, including seven chronic overlapping pain conditions (COPCs) such as irritable bowel syndrome, fibromyalgia, and migraine, as well as three CS-related disorders like anxiety, depression, and neck injury.
Measured: From enrollment to 1-month post treatment
Revised Mystical Experience Questionnaire (MEQ 30)
Provides a rating to assess phenomenology and intensity of mystical experiences, often in the context of altered states of consciousness, such as those induced by psychedelics.
Measured: 24-48 hours post psilocybin dose
Challenging Experience Questionnaire
Provides a rating to assess difficult or challenging psychological experiences, often in the context of altered states induced by psychedelics. It evaluates seven domains of challenging experiences: fear, grief, physical distress, insanity, isolation, death, and paranoia.
Measured: 24-48 hours post psilocybin dose
Modified Differential Emotions Scale (mDES) Questionnaire
Provides a rating to assess positive and negative emotion.
Measured: From enrollment to 1-month post treatment
Reactions to Touch Questionnaire
Provides a rating to assess a participant reactions to any physical touch between therapist and participant that occurs during the psychedelic sessions.
Measured: 24-48 hours post psilocybin dose
PTSD Checklist for DSM-5 Questionnaire
Provides a rating to assess the presence and severity of post-traumatic stress disorder (PTSD) symptoms based on DSM-5 criteria. It consists of 20 items corresponding to the four symptom clusters: re-experiencing, avoidance, negative alterations in cognition and mood, and hyper-arousal. Total score range of 0 to 80, with higher scores indicating greater symptom severity.
Measured: From enrollment to 1-month post treatment
Female Sexual Function Questionnaire
Provides a rating to assess female sexual health: desire, arousal, lubrication, orgasm, satisfaction, and pain, with each domain scored on a scale contributing to a total score indicated of a woman's sexual function.
Measured: From enrollment to 1-month post treatment
Expectancy Visual Analogue Scale
A simple expectancy visual analogue scale to provide a rating of treatment expectancy that will be used to assess the mediating effects of expectancy on treatment outcomes. How much do you think this treatment will reduce your pelvic pain? none to minimal reduction (0-4 mm), mild reduction (5-44 mm), moderate reduction (45-74 mm), substantial to complete reduction (75-100 mm).
Measured: Baseline visit
Beck Depression Inventory II
Provides a rating of depression severity. The score range is 0-63, a higher score reflects more severe depression.
Measured: From enrollment to 1-month post treatment
Beck Anxiety Inventory
Provides a rating of anxiety severity. The score range is 0-63, a higher score reflects more severe anxiety
Measured: From enrollment to 1-month post treatment
Self-Compassion Scale - Short Form
Provides a rating of self-compassion, or responding to one's own failure, suffering or inadequacies with kindness and compassion and recognizing one's own flaws and suffering as part of common human experience
Measured: From enrollment to 1-month post treatment
Snaith-Hamilton Pleasure Scale
Provides a rating of hedonic pleasure capacity in social interactions (sample item: "I would enjoy being with my family or close friends"). Each question is anchored to a time frame of the "past few days" and rated on a 1 (Strongly disagree) - 4 (Strongly agree) scale.
Measured: From enrollment to 1-month post treatment
CompACT-15
Provides a rating of psychological flexibility: openness to experience (5 items), behavioral awareness (5 items), and valued action (5 items).
Measured: From enrollment to 1-month post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility and Acceptability study to assess safety of a single dose of pharmaceutical grade psilocybin at 25 mg combined with psychotherapy in women with chronic pelvic pain
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Portland Psychotherapy Clinic, Research, and Training Center
- Responsible party
- Principal investigator, Lynne Shinto, ND, MPH, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988319
- Sponsor's protocol ID
- 28634
- Other IDs
- Circle of Giving Foundation
- Status last verified
- Sep 2026
- First submitted
- 2 May 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT06988319
- Acronym / sponsor ID
- 28634
- Conditions
- Chronic Pelvic Pain
- Keywords
- psilocybin, women, chronic pelvic pain, psilocybin assisted therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Portland Psychotherapy Clinic, Research, and Training Center
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Chronic pelvic pain (CPP) presents a significant challenge in healthcare, affecting approximately 15% of women in the United States and incurring annual healthcare costs upwards of $5.8 billion. This condition extends beyond persistent physical discomfort, profoundly impacting mental health and overall quality of life. Central to many chronic pain syndromes, CPP can lead to a heightened state of pain sensitivity known as central sensitization. This condition arises from neuroplastic changes within the central nervous system, leading to structural, functional, and chemical alterations in the brain that enhance neural reactivity, even in the absence of actual physical injuries. Central sensitization is characterized by widespread, multisite hyperalgesia and allodynia. These changes often co-occur with fatigue, mood and cognitive disturbances, sleep disruptions, and multisensory hypersensitivity, complicating the clinical picture and exacerbating the condition's impact on daily functioning.
The use of psilocybin in chronic pain is a paradigm shift from conventional pain therapy where the goal is pain alleviation, to changing a person's relationship with pain, offering a re-alignment or 'reset' of one's view of their pain, this is an innovative approach. To date, there are no psilocybin studies evaluating CPP.
This is a pilot feasibility and safety study to evaluate a single administration of psilocybin (25 mg) in women with CPP who have failed at least one conventional CPP therapy. The study will enroll 15 women, the primary aim is to assess feasibility that will be met when at least 80% of participants complete the study and attend 80% of 11 study visits (9/11 visits). Safety will be assessed by adverse event reports, safety labs, and vitals assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility and Acceptability study to assess safety of a single dose of pharmaceutical grade psilocybin at 25 mg combined with psychotherapy in women with chronic pelvic pain
| Arm | Type | Receives |
|---|---|---|
| Single dose psilocybin (25 mg) | Experimental | Drug: Psilocybin (Usona Institute)Single dose of pharmaceutical grade psilocybin (25 mg) with psychotherapy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin (Usona Institute)Single dose of pharmaceutical grade psilocybin (25 mg) combined with psychotherapy sessions | Drug | Single dose psilocybin (25 mg) |
Primary outcome
Recruitment and Retention Feasibility
Time frame: baseline to 1-month post psilocybin dose
Proportion of eligible participants who complete the study from baseline to 1 month post psilocybin dose
Acceptability
Time frame: End-of-Study Visit at 1-month post psilocybin dose
Acceptability will use qualitative data collection to provide information on the benefits and challenges of the intervention using a semi-structured interview.
Number of participants with treatment related adverse events
Time frame: From enrollment to 1-month post treatment
Adverse events will be collected using a 12- item adverse events checklist covering all major organ systems will be included to probe for adverse events. The nature of each AE, its severity (mild, moderate, or severe), its likely relationship to study treatment (definite, probable, possible, not related, or unknown), its duration and any necessary treatment modifications or adjustments will be recorded. In addition to recording of AEs,, and labs to assess basic metabolic function (including liver function tests), a complete blood count
14 secondary outcomes
Patient-Reported Outcome Measurement Information System (PROMIS) Pain interference Inventory
Time frame: From enrollment to 1-month post treatment
Central Sensitization Questionnaire
Time frame: From enrollment to 1-month post treatment
Revised Mystical Experience Questionnaire (MEQ 30)
Time frame: 24-48 hours post psilocybin dose
Challenging Experience Questionnaire
Time frame: 24-48 hours post psilocybin dose
Modified Differential Emotions Scale (mDES) Questionnaire
Time frame: From enrollment to 1-month post treatment
Reactions to Touch Questionnaire
Time frame: 24-48 hours post psilocybin dose
PTSD Checklist for DSM-5 Questionnaire
Time frame: From enrollment to 1-month post treatment
Female Sexual Function Questionnaire
Time frame: From enrollment to 1-month post treatment
Expectancy Visual Analogue Scale
Time frame: Baseline visit
Beck Depression Inventory II
Time frame: From enrollment to 1-month post treatment
Beck Anxiety Inventory
Time frame: From enrollment to 1-month post treatment
Self-Compassion Scale - Short Form
Time frame: From enrollment to 1-month post treatment
Snaith-Hamilton Pleasure Scale
Time frame: From enrollment to 1-month post treatment
CompACT-15
Time frame: From enrollment to 1-month post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin (Usona Institute) in people with Chronic Pelvic Pain, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lynne H Shinto, ND, MPH ((503) 494-5035, shintol@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and Retention Feasibility (time frame: baseline to 1-month post psilocybin dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.