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Serotonin Receptor Agonist

Brain Mapping with Psilocybin (Psilocybin PFM Trial)

Phase < 1
Waitlist Available
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
men and woman between 18 and 40 years of age;
No active psychiatric conditions requiring treatment with psychotropic medications (may be included if psychiatric condition is stable and participant is willing to discontinue medication for 1 month prior to participation with permission from their treating provider);
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights
No Placebo-Only Group

Psilocybin PFM Trial Summary

This trialwill use brain scans to study the effects of psilocybin (magic mushrooms) on the brain in healthy adults.

Who is the study for?
Healthy adults aged 18-40 with prior psychedelic use but not in the last 6 months can join. They must be off psychotropic meds for a month (with doctor's OK) and have no active psychiatric conditions needing such meds. Pregnant individuals, those with certain medical or psychiatric conditions, or metal implants that affect MRI scans cannot participate.Check my eligibility
What is being tested?
The study is examining how psilocybin affects brain function using brain imaging techniques. Participants will receive either psilocybin or methylphenidate to compare their effects on the brain networks of healthy adults.See study design
What are the potential side effects?
Psilocybin may cause changes in perception, mood swings, nausea, headache, increased heart rate and blood pressure. Methylphenidate could lead to nervousness, trouble sleeping, loss of appetite, weight loss and increased blood pressure.

Psilocybin PFM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 40 years old.
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I don't need psychotropic meds for my mental health or can stop them for a month.
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I am between 18 and 40 years old.
Select...
I am between 18 and 40 years old.
Select...
I don't need psychotropic meds for my mental health, or I can stop them with my doctor's okay.

Psilocybin PFM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Functional Connectivity
Secondary outcome measures
Mystical Experiences
Personality Change

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
44%
Headache
21%
Nausea
15%
Anxiety
8%
Suicidal Ideation
6%
Insomnia
6%
Depressed mood
4%
Abdominal pain upper
4%
Vomiting
4%
Corona virus infection
4%
Upper respiratory tract infection
4%
Viral upper resp. tract infection
4%
Alcohol poisoning
4%
Depression
4%
Pneumonia
2%
Urinary incontinence
2%
Illusion
2%
Biopsy cervix
2%
Palpitations
2%
Cataract
2%
Abdominal pain
2%
Toothache
2%
Pain
2%
Limb injury
2%
Muscle strain
2%
Blood pressure diastolic increased
2%
Blood pressure increased
2%
Back pain
2%
Musculoskeletal pain
2%
Myalgia
2%
Dizziness
2%
Psychomotor hyperactivity
2%
Alcohol withdrawal syndrome
2%
Dysphoria
2%
Testicular pain
2%
Hyperventilation
2%
Food poisoning
2%
Food allergy
2%
Dyspepsia
2%
Influenza
2%
Nasal congestion
2%
Skin cosmetic procedure
2%
Photopsia
2%
Diverticulitis
2%
Asthenia
2%
Fatigue
2%
Gingivitis
2%
Dyspnea
2%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Psilocybin
Diphenhydramine

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Psilocybin PFM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Psilocybin firstExperimental Treatment2 Interventions
Participants will receive 25 mg of psilocybin at the first of two neuroimaging sessions, taken orally in capsule form. Participants in this arm will receive the control drug (methylphenidate) at their second drug exposure neuroimaging session.
Group II: Methylphenidate firstActive Control2 Interventions
Participants in this group will be randomized to receive 40 mg of methylphenidate at the first of two neuroimaging sessions, taken orally in capsule form. Participants in this arm will receive the active comparator (psilocybin) at their second drug exposure neuroimaging session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylphenidate
2014
Completed Phase 4
~431850
Psilocybin
2021
Completed Phase 2
~770

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,917 Previous Clinical Trials
2,283,647 Total Patients Enrolled

Media Library

Psilocybin (Serotonin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04501653 — Phase < 1
Psilocybin Research Study Groups: Methylphenidate first, Psilocybin first
Psilocybin Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT04501653 — Phase < 1
Psilocybin (Serotonin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04501653 — Phase < 1
Psilocybin Patient Testimony for trial: Trial Name: NCT04501653 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any specific individuals who would be optimal for this clinical research?

"This medical trial is enrolling 25 individuals aged 18-40 who have previously utilized a psychedelic substance within the past 5 years, but not in the last 6 months. Furthermore, applicants must be without any active psychiatric conditions that necessitate psychotropic medications (although this may still be permissible if their condition is stable and they are willing to discontinue medication for at least 1 month with permission from their doctor)."

Answered by AI

Does this trial encompass geriatric candidates?

"This trial is designed to assess the efficacy of a new treatment on patients between 18 and 40 years old. There are 10 trials available for minors, as well as 42 studies that focus on seniors aged 65 or above."

Answered by AI

Has there been any additional empirical research surrounding the effects of Psilocybin?

"Presently, there are 61 studies actively exploring the effects of Psilocybin and 2 trials in their final phases. Even though Madison, Wisconsin hosts many of these experiments, they are being conducted at 77 different sites throughout the world."

Answered by AI

How many subjects have been recruited for this clinical trial?

"Currently, this research endeavour is not recruiting patients. It was posted on June 1st 2021 and the most recent update took place November 22nd 2022. If you are seeking other medical studies, there are 2 trials involving psilocybin that need participants as well as 61 additional clinical trials with a focus on Psilocybin actively enrollment new volunteers."

Answered by AI

Are there any vacancies available for potential participants in this clinical trial?

"Patient recruitment for this medical trial has been concluded; it was initially posted on June 1st 2021 and the last amendment was made November 22nd 2022. Luckily, there are currently 2 other studies recruiting patients to assess psilocybin and 61 active trials concerning Psilcybin that may still be looking for participants."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
Illinois
Missouri
Other
How old are they?
18 - 65
What site did they apply to?
Washington University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

How long is it? How long do screening visits take?
PatientReceived no prior treatments

Why did patients apply to this trial?

Interested in the effects of psilocybin. Very interested in how mushrooms can help people.
PatientReceived 1 prior treatment
I've tried spravato for my depression with little success. I have an interest in psychedelic therapies and believe research is important .
PatientReceived 1 prior treatment
I've never tried any drugs, tried cbd/thc gummies for the 1st time in my late 30s.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 1 Day
Most responsive sites:
  1. Washington University: < 24 hours
~3 spots leftby Jun 2024