Magic mushroom compound tested for stroke patients
NCT ID NCT07053917
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether psilocybin, a psychedelic substance, is safe for people who had a stroke at least a year ago. Researchers will monitor blood pressure and other vital signs in 20 participants. The goal is to see if psilocybin can help with lingering symptoms like weakness or paralysis.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: 1. selective serotonin reuptake inhibitor (SSRI) 2. Serotonin-norepinephrine reuptake inhibitors (SNRI) 3. Buproprion 4. Valproic acid 5. Zolpidem 6. Trazodone 7. Carbamazepine. 8. tricyclic antidepressants 9. Monoamine Oxidase Inhibitors 10. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins
RECRUITINGBaltimore, Maryland, 21287, United States
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Other studies related to the condition(s) this trial covers.
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