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.
Trial summary
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. Read more about this study
- 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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ceyda Sayali, PhD, Principal investigator, Johns Hopkins University
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
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.
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).
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.