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An Evaluation of Psilocybin's Effect on Cardiac Repolarization

Sponsor
Usona Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05478278
Collaborator
(none)
36
Enrollment
1
Location
4
Arms
11.3
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effects of a supratherapeutic dose of psilocybin on cardiac repolarization.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This study will be a double-blind, single-dose, randomized, placebo-controlled, 4-treatment, 4-period, 12-sequence crossover design in 36 healthy volunteers (adult male and/or female subjects). Subjects will be randomly assigned to 1 of 12 different treatment administration sequences, whereby each sequence will include 3 double-blind treatments (therapeutic dose of psilocybin, supratherapeutic dose of psilocybin, and placebo) and 1 open-label positive control treatment (moxifloxacin).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Thorough QT/QTc (TQT) Clinical Trial to Evaluate the Effect of Psilocybin on Cardiac Repolarization in Healthy Volunteers
Actual Study Start Date :
Jun 22, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment A (IP at therapeutic dose)

A single therapeutic dose of psilocybin.

Drug: Psilocybin
The psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active drug is encapsulated using a hydroxypropyl methylcellulose (HPMC) capsule and contains psilocybin (API only in a capsule).
Other Names:
  • Psilocybine
  • Psilocibin
  • Indocybin

    		•
    Experimental: Treatment B (IP at supratherapeutic dose)

    A single supratherapeutic dose of psilocybin.

    Drug: Psilocybin
    The psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active drug is encapsulated using a hydroxypropyl methylcellulose (HPMC) capsule and contains psilocybin (API only in a capsule).
    Other Names:
  • Psilocybine
  • Psilocibin
  • Indocybin

    		•
    Placebo Comparator: Treatment C (Placebo - Negative control)

    A single dose of placebo-to-match psilocybin MCC capsules.

    Drug: Micro-Crystalline Cellulose
    The placebo used in this study is encapsulated using a HPMC capsule and contains micro-crystalline cellulose.
    Active Comparator: Treatment D (Placebo - Positive control)

    A single 400 mg dose of moxifloxacin.

    Drug: Moxifloxacin
    The positive comparator used in this study is a 400 mg moxifloxacin tablet.
    Other Names:
  • Avelox
  • Moxeza

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline (Day -1) QTcF (ΔΔQTcF) following up to 24 hours post administration of a supratherapeutic dose of psilocybin. [up to 24 hours post-dose]

      Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔQTc interval will be extracted from the continuous digital 12-lead ECG recording at the -0.75, -0.50, and -0.25 hours prior to dosing and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose.

    Secondary Outcome Measures

    1. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [Up to 30 Days Post Dose]

      # of participants with TEAE following administration of psilocybin and moxifloxacin

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Provision of signed and dated informed consent form (ICF)

    • Stated willingness to comply with all study procedures and availability for the duration of the study

    • Healthy adult male or female

    • Aged at least 18 years but not older than 65 years, inclusive

    Exclusion Criteria:

    • History of significant hypersensitivity to psilocybin or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs

    • Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability

    • History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease

    • Showing suicidal ideation or behavior as per the Columbia Suicide Severity Rating Scale (C-SSRS) administered at screening

    • Presence of out-of-range cardiac interval (PR < 110 msec, PR > 200 msec, QRS < 60 msec, QRS >110 msec and QTcF > 450 msec for males and > 470 for females) on the ECG at screening or other clinically significant ECG abnormalities, unless deemed non-significant by an Investigator

    • History of risk factors for Torsades de Pointes (TdP), including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, or hypomagnesaemia

    • Family history of long QT syndrome or Brugada syndrome

    • Any clinically significant illness in the 28 days prior to the first study drug administration

    • Intake of psilocybin or any other psychedelic (including 3,4-methylenedioxymethamphetamine [MDMA] and ketamine) in the 28 days prior to the first study drug administration

    • Not suitable for participation in the study at the discretion of the Principal Investigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Altasciences Clinical Kansas, Inc Overland Park Kansas United States 66212

    Sponsors and Collaborators

    • Usona Institute

    Investigators

    • Study Director: Charles Raison, MD, Usona Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Usona Institute
    ClinicalTrials.gov Identifier:
    NCT05478278
    Other Study ID Numbers:
    • PSIL102-TQT
    First Posted:
    Jul 28, 2022
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Usona Institute
    Psilocybin, Psychedelics
    Additional relevant MeSH terms:
    Moxifloxacin
    Psilocybin

    Study Results

    No Results Posted as of Jul 28, 2022