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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;

Must not have

Presence of medical conditions that may confound results of imaging study or that are contraindications to psilocybin exposure (e.g. neurological, renal, hypertension, metabolic or cardiovascular disease or pregnancy)

No prior exposure to classic psychedelics (psilocybin, LSD, ayahuasca, mescaline)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week

Awards & highlights

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.

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 am between 18 and 40 years old.

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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have conditions like heart, kidney diseases, or pregnancy that would affect the study.

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I have never used psychedelics like psilocybin, LSD, ayahuasca, or mescaline.

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I do not have major mood disorders, substance use issues, or a family history of schizophrenia.

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I am taking medication for my mental health during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week

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

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Oropharyngeal pain

Suicidal Ideation

Insomnia

Influenza

Depression

Diarrhea

Headache

Sinus headache

Depressed mood

Lower resp. tract congestion

Alcohol withdrawal syndrome

Rhinorrhea

Musculoskeletal pain

Oedema

Pyrexia

Peripheral swelling

Restlessness

Vomiting

Fungal infection

Hypoesthesia

Thrombocytosis

Eye infection

Constipation

Dermatitis contact

Bronchitis bacterial

Traumatic lung injury

Hyponatremia

Arthralgia

Pain in extremity

Dizziness

Migraine

Sedation

Anger

Anxiety

Cough

Sexual abuse

Sinus congestion

Malignant melanoma

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

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

~750