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Psilocybin for Chronic Stroke Recovery

This study is looking at the safety of psilocybin (a psychedelic compound) in people who have had a stroke at least 12 months ago. Researchers want to see if psilocybin can help reopen a "critical period" in the brain, which might improve recovery from stroke-related problems like issues with language, thinking, or movement. You can join if you are over 18 and have had a confirmed stroke. The main goal is to check your blood pressure for up to 24 hours after receiving psilocybin to make sure it's safe. This study plans to enroll 20 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive psilocybin. It plans to enroll 20 participants.
What's involved
You will receive psilocybin and your blood pressure will be monitored for up to 24 hours. You must also agree not to take new prescription medications without study team approval during the study.
Compensation
Not stated in the trial record.
Follow-up
Your blood pressure will be monitored for up to 24 hours after psilocybin administration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07053917

Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability

Recruiting
PHASE1Ages 18+InterventionalTreatment
Johns Hopkins University
~20 participants
Updated 2026-02-13 on ClinicalTrials.gov
What's tested:Psilocybin (Usona Institute)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stability of systolic and diastolic blood pressure (mmHg)
Measured over up to 24 hours post-psilocybin administration

Conditions

Stroke
Chronic Stroke
Intracerebral Haemorrhage
Intracerebral Haemorrhage (ICH)
Intracerebral Hemorrhage Basal Ganglia
Ischemic Stroke
Ischemic Stroke and Hemorrhagic Stroke
Hemiparesis After Stroke
Hemiplegia Following Ischemic Stroke
Hemiplegia and Hemiparesis
Hemiplegia and/or Hemiparesis Following Stroke
Middle Cerebral Artery Stroke

Explore related trials

Cerebral HemorrhageIschemic Stroke

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Victor Urrutia, M.D. · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Steven R Zeiler, M.D., Ph.D.
[email protected]
303-520-7404
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Taking one of the following medications in the 30 days prior to psilocybin administration:
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.

What this trial measures

  • Stability of systolic and diastolic blood pressure (mmHg)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