Healthy VolunteersPhase 1OPTENCT06835699

Psilocybin Brain Stimulation and Imaging Pilot Study

A Phase 1 study testing Psilocybin 25 mgs and TMS in people with Healthy Volunteers, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 22 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Psilocybin 25 mgs and TMS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 18 Apr 2025to 21 May 2026
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Have given written informed consent
Right handed
Between the ages of 22 and 55 years old
Have a high school level of education
Be medically healthy and psychologically stable as determined by screening for medical problems via a personal interview, medical history and physical examination, psychiatric interview, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
Fluent in English and capable of providing informed consent

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Willing to remove any jewelry, hair clips, bobby pins, or any other potentially conducting or magnetic objects worn on or near the head
Have a minimum of 2 lifetime uses of a hallucinogen (e.g., Lysergic acid diethylamide (LSD), psilocybin mushrooms, N,N-dimethyltryptamine (DMT), ayahuasca, mescaline, Salvia divinorum, ketamine, dextromethorphan (DXM) , and phencyclidine (PCP). Only psychoactive and recreational use of the hallucinogenic drugs, including dextromethorphan and ketamine, will be factored into the calculation of lifetime use.
Cigarette smokers must agree to abstain from smoking on session days from 1 hour before drug administration
Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each drug administration. Exceptions include daily use of caffeine and nicotine.
Agree that for one week before each session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except if approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals
Agree not to take any "as-needed", pro re nata (PRN) prescription medications on the mornings of the sessions
Agree not to operate dangerous machinery or a motor vehicle for at least 12 hours after leaving the research unit
(for male participants) Agree to use contraception and refrain from sperm donation within two weeks of completing dosing sessions, as the reproductive safety for psilocybin is not yet established. Effective methods of contraception are barrier, hormonal and sterilization methods.
(for female participants) Agree to use highly effective birth control measure within two weeks of completing the dosing sessions. Effective methods of contraception are barrier, hormonal and sterilization methods.

Who cannot join

Weight greater than 350 lbs (the weight limit of the specialized TMS/EEG chair)
Weight less than 40 kg
Cardiovascular conditions: coronary artery disease, stroke, angina, hypertension with resting blood pressure systolic >139 or diastolic >89, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged corrected QT (QTc) interval (i.e., QTc > 450 msec), artificial heart valve, or Transient Ischemic Attack (TIA) in the past year
Hallucinogen use within the past 6 months (preference given to volunteers who have maintained a longer period of abstinence).
Epilepsy with history of seizures
Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia

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Current or past history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for schizophrenia, psychotic disorder (including of substance-induced but excluding due to a medical condition), dissociative disorder, bipolar I or II disorder, or an eating disorder
Have tinnitus or other hearing problems
Have a first degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I or II disorder
Have a first degree relative with a history seizures, epilepsy, or acute spells of unknown origin
Have an intracranial lesion
Have suffered ischemic or hemorrhagic stroke
Currently taking psychoactive prescription medication on a regular (e.g., daily) basis
Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting pharmacological effect on serotonin neurons or medications that are monoamine Oxidase (MAO) inhibitors. For individuals who have intermittent or PRN use of such medications, sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose
Currently taking the antiviral drug, efavirenz
Acute intoxication with any drug of abuse, including alcohol or cannabis
Current or past-year substance use disorder
Pregnancy
History of neurological problems, including epilepsy, seizures, syncope, tinnitus, migraine, or frequent non-migraine (e.g. tension) headaches
History of head trauma associated with loss of consciousness
Language or hearing impairment that would undermine communication regarding consent, study procedures, and overall volunteer safety.
Irritable skin
TMS-contraindicated medical devices, including cochlear implants, pacemaker, neurosensory stimulator, implantable defibrillator, insulin pump, clips, stents, or shunts that may be disrupted by or interact with TMS coil operation
Taking medications that lower seizure threshold
MRI contraindications (e.g. claustrophobia incompatible with MRI scanning, medical device or implant incompatible with MRI, prior history as a metal worker and/or certain metallic objects in the body -- must complete MRI screening form and be approved by MRI technologist before the scan

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins School of Medicine
Baltimore, Maryland, 21214

Other trials in United States

About this study

Official title: Open Label Psilocybin Brain Stimulation and Imaging Pilot Study

This open-label pilot psilocybin administration study investigates the influence of psilocybin on brain function and cognitive control functions in clinically and psychiatrically healthy volunteers. Participants will undergo experimental drug administration sessions after careful screening and preparation. Participants will also have brain activity measured using electroencephalogram (EEG) also during non-invasive brain stimulation using Transcranial Magnetic Stimulation (TMS).

Conditions: Healthy Volunteers
Being tested: Psilocybin 25 mgs, TMS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Psilocybin 25 mgsDrug
All participants will be administered 25 mg psilocybin and undergo TMS
TMSDevice
All participants will be administered 25 mg psilocybin and undergo TMS

Study groups in NCT06835699
Study group	Role	What they receive
Psilocybin and TMS	Experimental	All participants will be administered 25 mg psilocybin and undergo TMS Receives: Drug: Psilocybin 25 mgs; Device: TMS

What is being measured

The primary outcome is the main question the study is designed to answer.

Acute Change in Inhibitory EEG Component Amplitudes (N45, N100) from Baseline
Change in the amplitudes of inhibitory event-related potentials (ERPs), specifically the N45 and N100 components, from baseline to peak acute subjective effects (~1.5 hours post-psilocybin administration) will be calculated. This is a continuous variable expressed in microvolts (µV), derived from EEG recordings.
Measured: Baseline up to approximately 1.5 hours post psilocybin adminstration
Change in Mystical Experience Questionnaire (MEQ30)
The Mystical Experience Questionnaire was developed to assess phenomenological content during altered states of consciousness. Change in MEQ30 from baseline to peak acute psilocybin effects (~1.5 hr post-psilocybin administration) will be calculated. Score range 0 - 150 with higher scores reflecting more mystical experience.
Measured: Baseline up to to approximately 1.5 hours post psilocybin administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 202521 May 2026

First posted19 Feb 2025
Study start18 Apr 2025
Primary completion21 May 2026
Study completion21 May 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06835699
Sponsor's protocol ID: IRB00451481
Acronym: OPTE
Status last verified: Aug 2026
First submitted: 13 Feb 2025
Last updated: 7 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes

Publications

Atiq MA, Weisman E, Guerra RB, Martinez LL, Yaden DB, Barrett FS, Nayak S, Sayali C. Psilocybin-induced neurocardiogenic syncope: a case report. Psychopharmacology (Berl). 2026 May 28. doi: 10.1007/s00213-026-07079-8. Online ahead of print.
PubMed 42207275

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label Psilocybin Brain Stimulation and Imaging Pilot Study
ClinicalTrials.gov ID: NCT06835699
Acronym / sponsor ID: OPTE / IRB00451481
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Study start: 18 Apr 2025 (actual)
Primary completion: 21 May 2026 (actual)
Study completion: 21 May 2026 (actual)
First posted: 19 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Psilocybin and TMS	Experimental	Drug: Psilocybin 25 mgs, Device: TMSAll participants will be administered 25 mg psilocybin and undergo TMS

Who may qualify

Ages: 22 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (15 listed)

Have given written informed consent
Right handed
Between the ages of 22 and 55 years old
Have a high school level of education
Be medically healthy and psychologically stable as determined by screening for medical problems via a personal interview, medical history and physical examination, psychiatric interview, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests

Key exclusion criteria (25 listed)

Weight greater than 350 lbs (the weight limit of the specialized TMS/EEG chair)
Weight less than 40 kg
Cardiovascular conditions: coronary artery disease, stroke, angina, hypertension with resting blood pressure systolic >139 or diastolic >89, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged corrected QT (QTc) interval (i.e., QTc > 450 msec), artificial heart valve, or Transient Ischemic Attack (TIA) in the past year
Hallucinogen use within the past 6 months (preference given to volunteers who have maintained a longer period of abstinence).
Epilepsy with history of seizures

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Psilocybin 25 mgsAll participants will be administered 25 mg psilocybin and undergo TMS	Drug	Psilocybin and TMS
TMSAll participants will be administered 25 mg psilocybin and undergo TMS	Device	Psilocybin and TMS

Primary outcome

Acute Change in Inhibitory EEG Component Amplitudes (N45, N100) from Baseline
Time frame: Baseline up to approximately 1.5 hours post psilocybin adminstration
Change in the amplitudes of inhibitory event-related potentials (ERPs), specifically the N45 and N100 components, from baseline to peak acute subjective effects (~1.5 hours post-psilocybin administration) will be calculated. This is a continuous variable expressed in microvolts (µV), derived from EEG recordings.
Change in Mystical Experience Questionnaire (MEQ30)
Time frame: Baseline up to to approximately 1.5 hours post psilocybin administration
The Mystical Experience Questionnaire was developed to assess phenomenological content during altered states of consciousness. Change in MEQ30 from baseline to peak acute psilocybin effects (~1.5 hr post-psilocybin administration) will be calculated. Score range 0 - 150 with higher scores reflecting more mystical experience.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
Derived from this study: PubMed 42207275Atiq MA, Weisman E, Guerra RB, Martinez LL, Yaden DB, Barrett FS, Nayak S, Sayali C. Psilocybin-induced neurocardiogenic syncope: a case report. Psychopharmacology (Berl). 2026 May 28. doi: 10.1007/s00213-026-07079-8. Online ahead of print.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ceyda Sayali, PhD principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Psilocybin 25 mgs and TMS in people with Healthy Volunteers, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute Change in Inhibitory EEG Component Amplitudes (N45, N100) from Baseline (time frame: Baseline up to approximately 1.5 hours post psilocybin adminstration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06835699, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.