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| ID | Type | Description | Link |
|---|---|---|---|
| Circle of Giving Foundation | Other Identifier | Oregon Health & Science University |
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| Name | Class |
|---|---|
| Portland Psychotherapy Clinic, Research, and Training Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose psilocybin (25 mg) | Experimental | Single dose of pharmaceutical grade psilocybin (25 mg) with psychotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin (Usona Institute) | Drug | Single dose of pharmaceutical grade psilocybin (25 mg) combined with psychotherapy sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment and Retention Feasibility | Proportion of eligible participants who complete the study from baseline to 1 month post psilocybin dose | 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. | 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 | From enrollment to 1-month post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 1-month post treatment |
| Central Sensitization Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 1-month post treatment |
Inclusion Criteria:
Exclusion Criteria:
Chronic pelvic pain in women that include some gender specific conditions (e.g. endometriosis)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lynne H Shinto, ND, MPH | Contact | (503) 494-5035 | shintol@ohsu.edu | |
| Jacquelyn Knapp, MD | Contact | (510) 299-7662 | knapja@ohsu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
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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
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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. |
| 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. | 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. | 24-48 hours post psilocybin dose |
| Modified Differential Emotions Scale (mDES) Questionnaire | Provides a rating to assess positive and negative emotion. | 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. | 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. | 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. | 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). | 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. | 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 | 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 | 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. | 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). | From enrollment to 1-month post treatment |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |