Psilocybin for Pelvic Pain

JK
LH
Overseen ByLynne H Shinto, ND, MPH
Age: 18 - 65
Sex: Female
Trial Phase: Phase 1
Sponsor: Oregon Health and Science University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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

I have been diagnosed with chronic pelvic pain for 6 months or more.
I have tried at least one treatment for chronic pelvic pain without success.
I am a woman, aged 18-45, and have not gone through menopause.
See 2 more

Exclusion Criteria

History of or current primary psychotic disorder or bipolar disorder type 1
Positive urine drug test for illicit substance use
Score of 5 or greater on the Alcohol Use Disorder Identification Test- Consumption (AUDIT-C) indicating heavy alcohol use
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparatory Psychotherapy

Two pre-dose preparatory psychotherapy sessions to prepare participants for the psilocybin experience

1-2 weeks
2 visits (in-person)

Psilocybin Administration

Single administration of 25 mg psilocybin with monitoring for safety and initial effects

1 day
1 visit (in-person)

Integration Psychotherapy

Three post-dose integration psychotherapy sessions to help participants process their experience

2-3 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Psilocybin
Trial Overview The study is testing the safety and feasibility of using psilocybin in combination with psychotherapy to treat CPP in women. It involves a single moderate dose of psilocybin (25 mg) provided by Usona Institute, along with two preparatory and three integration therapy sessions surrounding the dosing event.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Single dose psilocybin (25 mg)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials
1,024
Recruited
7,420,000+

Portland Psychotherapy Clinic, Research, and Training Center

Collaborator

Trials
1
Recruited
90+

Citations

Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot ...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 ...
Can Psilocybin Help Manage Pelvic Pain?Evidence from related pain conditions suggests meaningful potential—both in macrodose and microdose formats.
Preliminary safety and effectiveness of psilocybin-assisted ...Some participants reported clinically meaningful improvements in pain severity, pain interference, anxiety, and sleep disturbance, with small improvements in ...
Are psychedelic medicines the reset for chronic pain? ...Preliminary evidence suggests that some psychedelics may be effective for certain types of pain and/or improved quality of life.
Psychedelics and chronic pain: self-reported outcomes on ...Psilocybin was also reported as the most effective substance for those who reported ceasing or decreasing use of both prescription opioids (33.3 ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40171515/
an open-label pilot clinical trialThis small open-label trial preliminarily supports that PAT is well-tolerated by people with FM, establishing a basis for larger randomized controlled trials.
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