Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability

NCT07053917 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IRB00274773
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

psychedelic; stroke; chronic stroke; intracerebral hemorrhage; stroke recovery; motor recovery; poststroke recovery; poststroke motor recovery; hemiparesis recovery; psychedelic safety

Outcome Measures

Primary Outcomes (1)

• 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

  up to 24 hours post-psilocybin administration

Secondary Outcomes (22)

• Number of adverse changes in vital signs that require medical attention

  up to 24 hours post-psilocybin administration

• Number of changes in psychiatric symptoms that require medical intervention

  up to 24 hours post-psilocybin administration

• Stability of pulse assessed by heart rate monitoring

  up to 24 hours post-psilocybin administration

• Oxygen Percent Saturation

  up to 24 hours post-psilocybin administration

• Number of participants with no change in EKG suggestive of ischemia

  up to 24 hours post-psilocybin administration

Study Arms (2)

25 mg of psilocybin

EXPERIMENTAL

Participants will receive 25 mg of psilocybin

Drug: Psilocybin (Usona Institute)

12.5 mg + 12.5 mg of psilocybin

EXPERIMENTAL

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)

Interventions

Psilocybin (Usona Institute) DRUG

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

12.5 mg + 12.5 mg of psilocybin; 25 mg of psilocybin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Taking one of the following medications in the 30 days prior to psilocybin administration:
• selective serotonin reuptake inhibitor (SSRI)
• Serotonin-norepinephrine reuptake inhibitors (SNRI)
• Buproprion
• Valproic acid
• Zolpidem
• Trazodone
• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Rose Hill: collaborator
• Usona Institute: collaborator
• University of California, Berkeley: collaborator

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Cerebral Hemorrhage; Ischemic Stroke; Hemorrhagic Stroke; Hemiplegia; Paresis; Infarction, Middle Cerebral Artery

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Paralysis; Neurologic Manifestations; Signs and Symptoms; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Infarction; Ischemia; Necrosis

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Victor Urrutia, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven R Zeiler, M.D., Ph.D.

CONTACT

303-520-7404; sz@jhmi.edu

Victor C Urrutia, M.D.

CONTACT

443-254-6435

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Phase 1 safety trial requires no blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: July 8, 2025
• Study Start: February 9, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)