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Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study

ConditionChronic Pelvic Pain
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorOregon Health and Science University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Psilocybin (Usona Institute)

    Drug

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

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Single dose psilocybin (25 mg)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Health and Science University

Lead sponsor

Portland Psychotherapy Clinic, Research, and Training Center

Collaborator

Source ClinicalTrials.gov
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