NCT07053917 Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability
| NCT ID | NCT07053917 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Johns Hopkins University |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-02-09 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-02-09 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main purpose of the current studies is to evaluate the safety and tolerability of psilocybin in patients with chronic stroke.
Eligibility Criteria
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.
Contact & Investigator
Victor Urrutia, M.D.
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT07053917 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07053917 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07053917 currently recruiting?
Yes, NCT07053917 is actively recruiting participants. Contact the research team at sz@jhmi.edu for enrollment information.
Where is the NCT07053917 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT07053917 clinical trial?
NCT07053917 is sponsored by Johns Hopkins University. The principal investigator is Victor Urrutia, M.D. at Johns Hopkins University. The trial plans to enroll 20 participants.
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