Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

selective serotonin reuptake inhibitor (SSRI)

Serotonin-norepinephrine reuptake inhibitors (SNRI)

Buproprion

Valproic acid

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psilocybin (Usona Institute)

    Drug

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: 25 mg of psilocybinExperimental treatment 1 intervention
Group B: 12.5 mg + 12.5 mg of psilocybinExperimental treatment 1 intervention

Trial outcomes

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

Time frame
up to 24 hours post-psilocybin administration

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

Rose Hill

Collaborator

Usona Institute

Collaborator

University of California, Berkeley

Collaborator