What side effects are associated with this type of intervention?

Psychoactive compounds like psilocybin, MDMA, and cannabinoids, which alter brain activity and cognition, are known to have several side effects. Common side effects include transient cognitive impairment, dizziness, drowsiness, impaired attention, and nausea. MDMA can also cause confusion, anxiety, and dissociation. Cannabinoids are associated with dizziness, sedation, confusion, and a feeling of being 'high.' These side effects are generally transient but can be significant depending on the dosage and individual response.

What prior FDA approvals exist?

The FDA has approved several drugs that affect brain activity and cognition, similar to psilocybin. For instance, ketamine, an anesthetic with psychoactive properties, has been approved for treatment-resistant depression in the form of esketamine (Spravato). Additionally, traditional antidepressants like SSRIs (e.g., fluoxetine, sertraline) and SNRIs (e.g., venlafaxine) are approved for various mental health conditions. While these drugs are not typically used in healthy subjects, they share the characteristic of altering brain activity and cognition, similar to the effects being studied with psilocybin.

What other types of research exist?

Promising novel alternatives to psilocybin for altering brain activity and cognition in healthy subjects include: 1) LSD (Lysergic acid diethylamide), which has shown potential in enhancing cognitive flexibility and emotional processing; 2) MDMA (3,4-Methylenedioxymethamphetamine), known for its effects on emotional regulation and social cognition; 3) Ketamine, which has rapid-acting antidepressant properties and can alter perception and cognition; and 4) Microdosing of various psychedelics, which involves taking sub-perceptual doses to potentially enhance creativity, focus, and emotional well-being without significant psychoactive effects.

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Psychedelic

Psilocybin for Healthy Subjects

Phase 1 & 2

Recruiting

Led By Frederick S Barrett

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18 to 75 years old

Have at least a high-school level of education or equivalent and be fluent in English

Must not have

Insulin-dependent diabetes or history of hypoglycemia while taking oral hypoglycemic agent

Pregnant or nursing women or sexually active women of child-bearing potential not practicing effective birth control

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Summary

This trial will study how psilocybin, a substance from certain mushrooms, affects thoughts and brain activity in healthy volunteers. Researchers will use computer tasks, EEG, and MRI to measure these effects. Understanding these changes may help improve future treatments and our knowledge of consciousness. Psilocybin, a psychoactive alkaloid found in hallucinogenic mushrooms, has been historically used for ritualistic, recreational, and medicinal purposes, with recent scientific interest in its potential therapeutic effects.

Who is the study for?

Participants must be healthy adults aged 18-75, vaccinated against COVID-19, fluent in English with at least high school education. They should have prior experience with psychedelics and agree to avoid psychoactive substances and certain medications before sessions. Pregnant or nursing women, individuals with cardiovascular issues, epilepsy, diabetes on insulin, psychiatric disorders or those taking serotonergic medications are excluded.

What is being tested?

The study examines the effects of psilocybin versus a placebo on thought processes and brain activity using EEG and MRI scans. Participants will perform computerized tasks while their brain responses are monitored to understand how this psychedelic compound affects them.

What are the potential side effects?

Psilocybin can cause altered sensory experiences and perception changes, confusion, emotional shifts ranging from euphoria to distress, potential anxiety or panic reactions during use. Long-term side effects are not well understood but could include persistent changes in perspective.

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 75 years old.

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I have completed high school or equivalent and am fluent in English.

Exclusion Criteria

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

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I have diabetes that requires insulin or have had low blood sugar with diabetes pills.

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I am not pregnant, nursing, or if capable of becoming pregnant, I am using effective birth control.

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My weight is within 20% of the ideal range for my height.

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I have epilepsy with a history of seizures.

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I have not had serious heart issues or uncontrolled high blood pressure in the past year.

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I regularly take medication that affects serotonin in my brain.

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I regularly take prescription medication for my mental health.

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A close family member has bipolar I, schizophrenia, or another psychotic disorder.

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I've had a head injury that knocked me out for more than 2 minutes.

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I do not have a psychiatric condition that makes psilocybin unsafe for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accuracy in the alternative uses task

Accuracy in the remote associates task as assessed by total correct number of trials

Alpha band power in EEG record

+3 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Diarrhea

Influenza

Headache

Sinus headache

Depressed mood

Depression

Insomnia

Suicidal Ideation

Lower resp. tract congestion

Oropharyngeal pain

Alcohol withdrawal syndrome

Migraine

Thrombocytosis

Constipation

Vomiting

Oedema

Peripheral swelling

Pyrexia

Dermatitis contact

Bronchitis bacterial

Eye infection

Fungal infection

Traumatic lung injury

Hyponatremia

Arthralgia

Musculoskeletal pain

Pain in extremity

Malignant melanoma

Dizziness

Hypoesthesia

Sedation

Anger

Anxiety

Restlessness

Cough

Rhinorrhea

Sinus congestion

Sexual abuse

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

Placebo Group

Group I: Psilocybin FirstExperimental Treatment2 Interventions

Psilocybin (10mg) will be administered one time orally as a capsule taken with water. Expected duration of acute effects is approximately 6 hours. After a period of a washout, participants will switch to the placebo intervention.

Group II: Placebo FirstPlacebo Group2 Interventions

Participants will be administered placebo in a clinical setting. Placebo is administered orally as a capsule taken with water. After a period of a washout, participants will switch to the Psilocybin intervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

Not yet FDA approved

Placebo

1995

Completed Phase 3

~2670

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Psilocybin, a psychoactive compound found in certain mushrooms, primarily acts on serotonin receptors, particularly the 5-HT2A receptor, leading to altered brain activity and cognition. This mechanism is significant for healthy subjects as it can induce changes in mood, perception, and thought processes, which are essential for understanding its therapeutic potential and managing its effects. Understanding these mechanisms helps in predicting outcomes, ensuring safe usage, and optimizing therapeutic benefits while minimizing risks.

How to account for hallucinations in the interpretation of the antidepressant effects of psychedelics: a translational framework.