Psilocybin for Pelvic Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether psilocybin, a compound found in certain mushrooms, can alleviate chronic pelvic pain when combined with therapy sessions. It targets women who have experienced this pain for at least six months and have not found relief with at least one other treatment. Participants should have a condition like endometriosis or irritable bowel syndrome, known to cause chronic pelvic pain. The trial aims to determine the treatment's safety and its potential for broader future application. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use lithium, cannabis, or certain hallucinogens before the study. If you use cannabis, you must be willing to taper off before the baseline visit.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that psilocybin is usually safe and well-tolerated for other pain conditions. In one study involving individuals with fibromyalgia, a long-term pain condition, psilocybin-assisted therapy was safe and well-received, with participants reporting positive experiences.
This trial is the first to specifically test psilocybin's safety for women with chronic pelvic pain. While the results appear promising, more information is needed to confirm its safety for this type of pain.
This is a Phase 1 trial, which primarily assesses safety and tolerability. So far, the findings are positive, but the research remains in the early stages.12345Why do researchers think this study treatment might be promising for pelvic pain?
Unlike the standard treatments for pelvic pain, which often include medications like NSAIDs, opioids, or hormonal therapies, psilocybin offers a novel approach by targeting the brain's perception of pain. Researchers are excited about psilocybin because it works on the serotonin receptors in the brain, potentially altering pain pathways and providing relief in a new way. Additionally, psilocybin is administered in a single dose combined with psychotherapy, which could offer rapid and lasting effects, reducing the need for ongoing medication. This unique mechanism and delivery method set psilocybin apart from traditional pain management options.
What evidence suggests that psilocybin might be an effective treatment for chronic pelvic pain?
Research has shown that psilocybin, the main ingredient in magic mushrooms, might help manage chronic pelvic pain (CPP). Some studies suggest that psilocybin can lessen pain and improve quality of life for individuals with various chronic pain conditions. Participants in these studies reported significant improvements in pain, anxiety, and sleep after using psilocybin. It has also helped individuals reduce or stop using prescription pain medications, such as opioids. Although more research is needed, early findings suggest psilocybin could be a promising option for those with CPP who haven't found relief with other treatments. Participants in this trial will receive a single dose of pharmaceutical-grade psilocybin (25 mg) combined with psychotherapy to evaluate its effectiveness for CPP.12356
Are You a Good Fit for This Trial?
This trial is for women who have been experiencing chronic pelvic pain (CPP) for at least 6 months, diagnosed by a specialist. They must have tried and not responded to one conventional treatment for CPP, such as medication or surgery. Participants should be generally healthy without any serious physical or mental health conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preparatory Psychotherapy
Two pre-dose preparatory psychotherapy sessions to prepare participants for the psilocybin experience
Psilocybin Administration
Single administration of 25 mg psilocybin with monitoring for safety and initial effects
Integration Psychotherapy
Three post-dose integration psychotherapy sessions to help participants process their experience
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oregon Health and Science University
Lead Sponsor
Portland Psychotherapy Clinic, Research, and Training Center
Collaborator