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NCT07053917 · Johns Hopkins University

Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability

(PHATHOM)

What this study is about

The main purpose of the current studies is to evaluate the safety and how well patients handle the treatment of psilocybin in patients with chronic stroke.

View original scientific description

The main purpose of the current studies is to evaluate the safety and tolerability of psilocybin in patients with chronic stroke.

Interventions

DRUG

Psilocybin (Usona Institute)

Participants will receive psilocybin to test its safety. Secondary outcomes will assess recovery from post-stroke deficits.

Primary outcome measures

Stability of systolic and diastolic blood pressure (mmHg)

Time frame: up to 24 hours post-psilocybin administration

Will be measuring the number of participants that meet these criteria: 1. no sustained elevation of systolic blood pressure of more than 180 mmHg on more than two readings sustained for more than 20 minutes. 2. no sustained elevation of diastolic blood pressure of more that 120 mmHg on more than two reading sustained for more than 20 minutes. 3. No sustained reduction of systolic blood pressure of less than 70 mmHg on more than two readings sustained for more than 20 minutes. 4. No sustained reduction of diastolic blood pressure of less than 40 mmHg on more than two readings sustained for more than 20 minutes

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Over age 18 years, inclusive.
  • Ischemic or hemorrhagic stroke confirmed by CT or MRI, at least 12 months prior to admission date
  • Ability to give informed consent and understand the tasks involved.
  • Agree that, for the study duration, will refrain from: (1) No new prescription medications during the time of the study without approval of the study team, (2) taking any herbal supplement (except with prior approval of the research team), (3) taking any nonprescription medications with the exception of: 1. non-steroidal anti-inflammatory drugs. 2. acetaminophen. 3. vitamins. 4. or other over-the-counter medications approved by the research team
  • Are willing to follow restrictions and guidelines concerning medications, consumption of food, beverages, and nicotine the night before and just prior to psilocybin administration.
  • Agree to have transportation other than driving themselves home or to where the participants are staying after the administration of psilocybin.
  • Are willing to be contacted via telephone for all necessary telephone contacts.
  • Must have a negative pregnancy test if able to bear children.
  • Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal.
  • Must agree to inform the investigators within 48 hours of any new medical conditions and procedures.
  • Are proficient in speaking and reading English.
  • Agree to have all clinical visit sessions recorded to audio and video.
  • Agree to not participate in any other interventional clinical trials during the duration of this study.

Exclusion criteria

  • Taking one of the following medications in the 30 days prior to psilocybin administration:
  • selective serotonin reuptake inhibitor (SSRI)
  • Serotonin-norepinephrine reuptake inhibitors (SNRI)
  • Valproic acid
  • Carbamazepine.
  • tricyclic antidepressants
  • Monoamine Oxidase Inhibitors
  • Mirtazapine l. Lithium m. Buspirone n. Atypical antipsychotics o. Zolpidem p.Carbamazepine q. Clonazepam r. Gabapentin s. Lamotrigine t. Levetiracetam u. Phenobarbital v. Phenytoin w. Topiramate x. Valproic Acid y. Zonisamide
  • History of medically significant suicide attempt.
  • Evidence of acute cardiac dysfunction as evidenced by either elevated troponin or EKG changes within 48 hours of administration.
  • Systolic blood pressure that is greater than 150 mmHg systolic on \> 2 readings during the 7-day monitoring period AND blood pressure medication management has been assured.
  • Diastolic blood pressure that is greater than 100 mmHg systolic on \> 2 readings during the 7-day monitoring period AND blood pressure medication management has been assured.
  • Systolic blood pressure is less than 90 mmHg systolic on \> 2 readings during the 7-day monitoring period after blood pressure medication management has been assured.
  • Diastolic blood pressure is less than 30 mmHg systolic on \> 2 readings during the 7-day monitoring period after blood pressure medication management has been assured.
  • Systolic blood pressure exceeds 160 mmHg or is less than 90 mmHg immediately prior to administration of psilocybin; patients are allowed to be on anti-hypertensives.
  • Diastolic blood pressure exceeds 100 mmHg or is less than 30 mmHg immediately prior to administration of psilocybin; patients are allowed to be on anti-hypertensives.
  • Cognitive impairment that, in the estimation of the study team, would preclude the use of the MindPod Dolphin.
  • History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's disease).
  • Social and/or personal circumstances that interfere with ability to perform follow up assessments.
  • Are pregnant or nursing.
  • Weigh less than 48 kg.
  • Are not able to give adequate informed consent.
  • Are actively abusing opioids, cocaine, Phencyclidine (PCP), amphetamines, or alcohol.
  • Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5) criteria for moderate or severe substance use disorder
  • Diagnosis of schizophrenia, history of prior psychosis, anxiety requiring hospitalization, or Type 1 bipolar.
  • Hypernatremia
  • Hypokalemia (but can have received repletion during the prior 24 hours)
  • Hyperkalemia
  • Glomerular filtration rate of \< 30 ml/min
  • Elevated of white blood cell count
  • Hemoglobin \< 7 g/dl
  • Platelet count \< 100,000 g/dl
  • Acute cardiac dysfunction demonstrated by either troponin elevation (chronic elevation is acceptable), or EKG changes suggestive of acute coronary syndrome.
  • Active suicidal ideation as assess by the C-SSRS.

Where

  • Baltimore, Maryland

Collaborators

Rose Hill, Usona Institute, University of California, Berkeley

Related conditions & keywords

StrokeChronic StrokeIntracerebral HaemorrhageIntracerebral Haemorrhage (ICH)Intracerebral Hemorrhage Basal GangliaIschemic StrokeIschemic Stroke and Hemorrhagic StrokeHemiparesis After StrokeHemiplegia Following Ischemic StrokeHemiplegia and HemiparesisHemiplegia and/or Hemiparesis Following StrokeMiddle Cerebral Artery Strokepsychedelicintracerebral hemorrhage

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Feb 13, 2026 · Source of record for eligibility and locations

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Stroke Treatment Options in Baltimore, Maryland

If you're searching for Stroke treatment in Baltimore, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Baltimore and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Stroke. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Maryland
Now Enrolling
Up to 20 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Stroke?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Stroke

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Stroke Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07053917. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.