Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Recruitment and Retention Feasibility
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Single dose psilocybin (25 mg)
Single dose of pharmaceutical grade psilocybin (25 mg) with psychotherapy
干预措施: Psilocybin (Usona Institute) (Drug)
结局指标
主要结局
Recruitment and Retention Feasibility
时间窗: baseline to 1-month post psilocybin dose
Proportion of eligible participants who complete the study from baseline to 1 month post psilocybin dose
Acceptability
时间窗: 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
时间窗: 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
次要结局
- Patient-Reported Outcome Measurement Information System (PROMIS) Pain interference Inventory(From enrollment to 1-month post treatment)
- Central Sensitization Questionnaire(From enrollment to 1-month post treatment)
- Revised Mystical Experience Questionnaire (MEQ 30)(24-48 hours post psilocybin dose)
- Challenging Experience Questionnaire(24-48 hours post psilocybin dose)
- Modified Differential Emotions Scale (mDES) Questionnaire(From enrollment to 1-month post treatment)
- Reactions to Touch Questionnaire(24-48 hours post psilocybin dose)
- PTSD Checklist for DSM-5 Questionnaire(From enrollment to 1-month post treatment)
- Female Sexual Function Questionnaire(From enrollment to 1-month post treatment)
- Expectancy Visual Analogue Scale(Baseline visit)
- Beck Depression Inventory II(From enrollment to 1-month post treatment)
- Beck Anxiety Inventory(From enrollment to 1-month post treatment)
- Self-Compassion Scale - Short Form(From enrollment to 1-month post treatment)
- Snaith-Hamilton Pleasure Scale(From enrollment to 1-month post treatment)
- CompACT-15(From enrollment to 1-month post treatment)
研究者
Lynne Shinto, ND, MPH
Professor of Neurology
Oregon Health and Science University