Chronic Pelvic Pain study: Psilocybin
Official title Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study
ClinicalTrials.gov ID: NCT06988319
What this study is testing
What is Psilocybin (Usona Institute)?
This is an investigational treatment being studied for chronic pelvic pain. It is designed to work by affecting brain chemicals to change how the brain processes pain signals.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if it is possible to enroll women and gather early safety data on using psilocybin with therapy.
- Who it's for
- Women with chronic pelvic pain who have already tried one standard treatment without success.
- What's involved
- Participants take one dose of psilocybin and attend five therapy sessions: two before the dose and three after.
- Time commitment
- The study involves five therapy sessions and one medication dose, but the total duration is not specified.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- 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...
- Failing at least 1 treatment for CPP. Failed conventional interventions include pharmacotherapy, non-pharmacotherapy (bladder installations...
- Participants will be generally healthy with no exclusionary physical or mental health conditions.
You likely can't join if
- Pelvic pain that is not defined as chronic (e.g. acute pelvic or vaginal infections such as sexually transmitted infections, urinary tract...
- 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.
- 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
See the full eligibility 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...
- Failing at least 1 treatment for CPP. Failed conventional interventions include pharmacotherapy, non-pharmacotherapy (bladder installations, neuromodulation, trigger point injections, anesthetic blocks, surgery)...
- Participants will be generally healthy with no exclusionary physical or mental health conditions.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Portland, Oregon, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Portland, Oregon, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.