Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study (NCT06988319) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study
United States15 participantsStarted 2026-01-01
Plain-language 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 pre-dose preparatory and three post-dose integration sessions).
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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…
What they're measuring
1
Recruitment and Retention Feasibility
Timeframe: baseline to 1-month post psilocybin dose
2
Acceptability
Timeframe: End-of-Study Visit at 1-month post psilocybin dose
3
Number of participants with treatment related adverse events
Timeframe: From enrollment to 1-month post treatment