A Phase 1 interventional study of Psilocybin (Usona Institute) in Chronic Pelvic Pain, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Oregon Health and Science University · Phase 1, Interventional, and Treatment
Among 151 studies in Pelvic Pain with a site in United States — 36 open to participants now, 39 under way, 1 of them phase 3. Pelvic Pain · United States.
Among the 151 studies in Pelvic Pain with a site in United States, this one is the 93rd largest by planned enrollment of the 123 interventional ones, is one of 14 that started in 2026, is one of 7 in phase 1, reaches primary completion later than 22 of the 38 other live ones, and was the 137th registered.
375 studies on the registry are indexed under Pelvic Pain; 89 are open to participants now.
This study's planned enrollment of 15 is below the median of 60 across 277 interventional studies indexed under Pelvic Pain.
Browse Pelvic Pain studies →36 of the 151 studies in Pelvic Pain with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 59 Pelvic Pain studies recruiting now, 21 (36%) set no upper age limit and 36 (61%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 45 Years · female · no healthy volunteers.
The full table on the hub →151 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 14 started in 2026.
Median enrollment 50 across the 123 interventional studies, 104 across the 28 observational. Of the 96 that completed or were terminated, 35 (36%) have results posted.
18 of 151 have an industry lead sponsor. The 10 most frequent:
Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.
Oregon Health and Science University has 3 studies filed under Pelvic Pain — fewer than ten, so there is no comparison to draw.
15 of the studies in Pelvic Pain with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06110065University of ArizonaCT-guided Pudendal Nerve Cryoneurolysis for Palliation of Malignancy-induced Pelvic Pain | 2026-11 |
| NCT05354869University of California, Los AngelesTransvaginal Electrical Stimulation for Myofascial Pelvic Pain | 2026-12 |
| NCT03794466University of Kansas Medical CenterQuantify the Degree of Pain Relief of Pelvic Congestion Syndrome Following Gonadal Vein Embolization | 2026-12-31 |
| NCT06083597Weill Medical College of Cornell UniversityDevelopment of a Patient-reported Outcome Measure for Women With Chronic Pelvic Pain | 2026-12-31 |
| NCT06611501Boston Children's HospitalGlycemic Regulation as Endometriosis Adjunct Treatment | 2027-01 |
Among the 151 studies in Pelvic Pain with a site in United States, from their registry updates:
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).
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Single dose of pharmaceutical grade psilocybin (25 mg) with psychotherapy
Drug: Psilocybin (Usona Institute)
Single dose of pharmaceutical grade psilocybin (25 mg) combined with psychotherapy sessions
Recruitment and Retention Feasibility
Proportion of eligible participants who complete the study from baseline to 1 month post psilocybin dose
Time frame: 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.
Time frame: 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
Time frame: From enrollment to 1-month post treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24-48 hours post psilocybin dose
Modified Differential Emotions Scale (mDES) Questionnaire
Provides a rating to assess positive and negative emotion.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: From enrollment to 1-month post treatment
Columbia-Suicide Severity Rating Scale
A clinician or self-administered tool designed to assess suicidal ideation and behavior. It evaluates the severity and intensity of suicidal thoughts, including wish to die, active suicidal ideation with or without a plan, and preparatory acts. It also captures suicidal behavior such as attempts, interrupted or aborted attempts, and non-suicidal self-injury.
Time frame: From enrollment to 1-month post treatment
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
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Studies of the drug tested here: Psilocybin
Oregon Health and Science University →