Psilocybin Mushrooms for PTSD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sue Sisley

Must not be taking: SSRIs, SNRIs, MAOs, others

Disqualifiers: Uncontrolled hypertension, Seizure, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether psilocybin mushrooms, a type of psychedelic treatment, can safely help treat PTSD (Post-Traumatic Stress Disorder). Participants will consume mushrooms in chocolate form to determine if it eases PTSD symptoms. The trial seeks adults who have experienced PTSD for at least six months and are willing to adhere to the study's rules, such as abstaining from similar drugs for a specified period. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial requires that you be stable on any pre-study medications and inform your current healthcare providers about your participation. You must avoid certain medications like SSRIs, SNRIs, and MAOs within 24 hours of the study day, but daily use of caffeine, nicotine, and opioid pain medication is allowed.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that psilocybin, found in certain mushrooms, is often safe in controlled settings. Studies have found that when administered in a supervised environment with a medical team, psilocybin is usually well-tolerated, with serious side effects being rare. Most side effects are mild, such as temporary feelings of anxiety or dizziness.

For individuals with PTSD (Post-Traumatic Stress Disorder), psilocybin might help by altering negative thought patterns. Early findings suggest that even one dose can reduce PTSD symptoms when combined with therapy. However, since this study is in its early stages, the primary goal is to better understand its safety. This phase focuses on ensuring the treatment does not cause significant harm. While the results are promising, further research is needed to confirm them. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard PTSD treatments, which often include psychotherapy and medications like SSRIs, psilocybin-containing mushrooms offer a novel approach. Researchers are excited about these treatments because psilocybin acts on serotonin receptors in the brain, potentially providing rapid and profound effects on mood and perception. This could lead to quicker relief of PTSD symptoms, possibly after just a single dosing session. Additionally, the use of organic whole mushrooms as the delivery method is unique, offering a natural alternative to synthesized pharmaceuticals.

What evidence suggests that psilocybin mushrooms might be an effective treatment for PTSD?

Research has shown that psilocybin, the main ingredient in magic mushrooms, might help reduce PTSD symptoms. Studies have found that just one dose of psilocybin, when combined with therapy, can lessen PTSD symptoms in adults. Additionally, research from Johns Hopkins discovered that psilocybin can ease symptoms of major depression, indicating its potential for treating mental health issues like PTSD. Early results suggest that psilocybin could be a promising treatment option, prompting growing interest in further study. In this trial, participants will receive 30mg of psilocybin administered orally in a single dosing session to evaluate its effectiveness for PTSD. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with PTSD who can safely ingest psilocybin mushrooms. Specific eligibility details are not provided, but typically participants must be in good health and meet diagnostic criteria for PTSD.

Inclusion Criteria

My kidney function is good.

My liver is functioning well, with enzymes not exceeding 1.5 times the upper limit.

Willing and able to provide signed informed consent and comply with study requirements

Exclusion Criteria

My blood pressure is not controlled by medication.

I have had a seizure recently.

I have had a stroke or a transient ischemic attack.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral dose of 30mg psilocybin in a chocolate formulation

1 day

1 visit (in-person)

Pharmacokinetic Monitoring

Participants are monitored for pharmacokinetic parameters such as Cmax, Tmax, and AUC₀-₈ of psilocin

8 hours

Continuous monitoring during treatment visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Organic Whole Psilocybin-Containing Mushrooms

Trial Overview

The study is testing the safety and initial effectiveness of psilocybin mushrooms, taken as a chocolate formulation, to help treat symptoms of PTSD in up to 24 adults.

How Is the Trial Designed?

Group I: 30mg of psilocybin administered orally in a single dosing session Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Sue Sisley

Lead Sponsor

Scottsdale Research Institute

Collaborator

Citations

1.

ptsd.va.gov

ptsd.va.gov/professional/treat/txessentials/psychedelics_assisted_therapy.asp

Psychedelic-Assisted Therapy for PTSD

Finally, preliminary data suggests that a single administration of psilocybin along with group psychotherapy can decrease symptoms of PTSD in older long-term ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07275970

Safety and Preliminary Efficacy of Organic Whole ...

This study will examine the safety and preliminary efficacy of psilocybin mushrooms to treat adults with PTSD. Up to 24 participants will ...

3.

hopkinsmedicine.org

hopkinsmedicine.org/psychiatry/research/psychedelics-research

Psychedelics Research and Psilocybin Therapy

Previous studies by Johns Hopkins Medicine researchers showed that psychedelic treatment with psilocybin relieved major depressive disorder symptoms in adults ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10845102/

The Psychedelic Future of Post-Traumatic Stress Disorder ...

While data thus far suggest that psychedelic-assisted psychotherapy (PAP) has the potential to be a successful treatment for PTSD, several features of these ...

5.

axios.com

axios.com/local/phoenix/2025/11/10/psilocybin-mushrooms-ptsd-study-scottsdale-research-institute

Scottsdale lab to study use of whole psilocybin mushrooms ...

Why it matters: There is a growing body of research suggesting that psilocybin could be effective at treating PTSD.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12146596/

Clinical conceptualisation of PTSD in psilocybin treatment

Thus, psilocybin may facilitate remodelling of maladaptive cognitive and emotional patterns common in PTSD, particularly within a therapeutic ...

7.

med.nyu.edu

med.nyu.edu/departments-institutes/population-health/divisions-sections-centers/medical-ethics/education/high-school-bioethics-project/learning-scenarios/ptsd-treatment-psychedelics

Post-Traumatic Stress Disorder Treatment with Psychedelic ...

Learn how the chemical psilocybin, found in psychedelic drugs, can potentially help people who have PTSD, and discuss the ethical implications.