A Phase 1 interventional study of Psilocybin (Usona Institute) in Stroke, Chronic Stroke and Intracerebral Haemorrhage, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by Johns Hopkins University · Phase 1, Interventional, and Treatment
The main purpose of the current studies is to evaluate the safety and tolerability of psilocybin in patients with chronic stroke.
Stroke is the leading cause of death and adult disability worldwide, and every year more than 795,000 people in the United States have a stroke. According to the National Stroke Association, only 10 percent of people who have a stroke recover completely, while 50 percent experience moderate to severe long-term disability, including significant impairment in language, cognition, motor, and sensory skills, which require special care or long-term care in a nursing home or other facility. Therefore, in the United States alone, nearly 400,000 people per year will suffer the lasting debilitating consequences of stroke. Previous studies have indicated that rehabilitation following stroke is constrained by a so-called 'critical' or 'sensitive' period. While this learning window can be extended or enhanced, once the post-stroke rehabilitation critical period has closed, clinically applicable manipulations that can reopen it are lacking.
Recently the investigators have shown that the psychedelic compounds like psilocybin, lysergic acid diethylamide (LSD), and 3,4-methylenedioxmethamphetamine (MDMA) can reopen a novel critical period for social reward learning. The adage "you can't teach an old dog new tricks" captures a certain truth about the brain. Specifically, a young person's brain is much more malleable (e.g., able to make new motor-memories and store new motor-memories) compared to an adult's brain. Neuroscientists call these periods of heightened sensitivity to input "critical periods." Based on these observations the investigators posit that psychedelic compounds serve as the long sought-after "master key" for unlocking critical periods across the brain. Ongoing preclinical studies are examining this possibility, with the goal of determining the therapeutic potential of psychedelics (including psilocybin) as adjunct therapies for any intervention whose clinical efficacy may be constrained by critical period closure, including post-stroke rehabilitation.
The main purpose of the proposed studies is to evaluate the safety and tolerability of psilocybin in stroke patients (Phase 1). as a secondary aim the investigators will collect data on the efficacy of psilocybin in effecting motor recovery in post-stroke patients.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 20 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Taking one of the following medications in the 30 days prior to psilocybin administration:
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 25 mg of psilocybin
Drug: Psilocybin (Usona Institute)
Participants will receive 12.5 mg of psilocybin followed by another 12.5 mg of psilocybin 2 hours after the first dose.
Drug: Psilocybin (Usona Institute)
Participants will receive psilocybin to test its safety. Secondary outcomes will assess recovery from post-stroke deficits.
Stability of systolic and diastolic blood pressure (mmHg)
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
Time frame: up to 24 hours post-psilocybin administration
Number of adverse changes in vital signs that require medical attention
Adverse change in vital signs, not otherwise meeting specified outcome criteria, that a treating provider feels requires medical intervention.
Time frame: up to 24 hours post-psilocybin administration
Number of changes in psychiatric symptoms that require medical intervention
Significant psychiatric symptoms within 24 hours post-dosing as determined by clinical staff to require medical intervention
Time frame: up to 24 hours post-psilocybin administration
Stability of pulse assessed by heart rate monitoring
no resting tachycardia for more than 20 minutes defined as heart rate greater than 110 bpm, or resting bradycardia for more than 20 minutes defined as less than 40 bpm.
Time frame: up to 24 hours post-psilocybin administration
Oxygen Percent Saturation
Stability of pulse oximetry. No reduction of percent saturation of less than 87% as assess by pulse oximetry on more than two readings sustained for more than 10 minutes.
Time frame: up to 24 hours post-psilocybin administration
Number of participants with no change in EKG suggestive of ischemia
No change in EKG suggestive of ischemia
Time frame: up to 24 hours post-psilocybin administration
Number of participants without seizures
No seizures assessed by clinical observation and examination
Time frame: up to 24 hours post-psilocybin administration
Number of Participants without elevation of cardiac troponin
Troponin assessed by serum quantification
Time frame: up to 24 hours post-psilocybin administration
Suicidal ideation assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale (C- SSRS) before, during and after experimental sessions and on selected days of telephone or face-to-face contact. Score range 0-25 with higher scores indicating more severe suicidal ideation.
Time frame: Day 1, prior to dosing-24 hours post-dosing (+/- 5 hours) weekly, up to 3 weeks
Number of deviations from pre-dosing electrolyte levels as assessed by CMP
Deviation from pre-dosing values of sodium, potassium, chlorine, and calcium, will be assessed by comprehensive metabolic panel (CMP)
Time frame: Pre-dosing and between 8 and 24 hours post-psilocybin dosing
Neurologic Impairment as assessed by The National Institutes of Health Stroke Scale (NIHSS)
Secondary recovery outcome. Scores range from 0 to 42, with higher scores indicating increasing severity
Time frame: 30 days and 90 days
Motor Function as assessed by the Fugl-Meyer Upper Extremity Motor Assessment (FM-UE)
Secondary recovery outcome. The score range is 0 to 66. A lower score indicates impaired motor function in the upper extremity assessed.
Time frame: 30 days and 90 days
Amount of recovery of arm-hand function as assessed by the Action Research Arm Test (ARAT)
Secondary recovery outcome. Scores range from 0-to-57 with a higher score indicating a better outcome.
Time frame: 30 days and 90 days
Global disability as assessed by the Modified Rankin Scales (mRS)
Secondary recovery outcome. Modified Rankin Scales (mRS) is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes.
Time frame: 30 days and 90 days
Function as assessed by the Barthel Index (BI)
Secondary recovery outcome. Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function.
Time frame: 30 days and 90 days
Montreal cognitive assessment (MOCA)
Secondary recovery outcome. MOCA score ranges from 0-30, with higher score being better performance.
Time frame: 30 days and 90 days
Digital hand kinematics
Secondary recovery outcome. Change in fingertip individuation index as assessed by kinematic measurement of digit movement using a device that uses sensor-based technology to capture joint range of motion. Full extension and flexion of each digit in isolation will be captured using this technology and compared.
Time frame: 30 days and 90 days
Change in finger dexterity as assessed by the nine-hole peg test (9PHT)
Secondary recovery outcome. The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses. Participants are asked to place pegs into the holes one at a time, then remove them one at a time, and place them back in the container as fast as they can.
Time frame: 30 days and 90 days
Grasp Performance
Secondary recovery outcome. Change in gross grasp will be measured using dynamometry in pours of force output. three measure will be take on the right and left hand and the value will be averaged using a calibrated dynamometer. greater force output is equal to greater grip strength.
Time frame: 30 and 90 days
10m walk time
Secondary Recovery Outcome. Patients are asked to walk 10m. faster is better.
Time frame: 30 days and 90 days
Depression as assessed by the Patient Health Questionnaire (PHQ)
Secondary recovery outcome. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe (range of 0-27)
Time frame: 30 days and 90 days
Stroke Impact Scale (SIS)-16
The Stroke Impact Scale (SIS)-16 consists of 16 items from the 4 physical domains (strength, hand function, mobility, and ADL/IADL) to assess recovery post-stroke. Total score ranges between 0-100; higher scores are better.
Time frame: 90 days
Secondary recovery outcome - post-study assessment survey
Survey designed to assay participant's enjoyment and self-assessed recovery
Time frame: 90 days
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Feb 2027, 12 months after the start.
Of 71 non-industry phase 1 interventional studies under Stroke, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 12 months is below that.
Counting every sponsor, half of 97 studies reached it within 20 months; a quarter within 7 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Psilocybin