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An Evaluation of Psilocybin's Effect on Cardiac Repolarization

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ClinicalTrials.gov Identifier: NCT05478278
Recruitment Status : Recruiting
First Posted : July 28, 2022
Last Update Posted : July 28, 2022
Sponsor:
Information provided by (Responsible Party):
Usona Institute

Tracking Information
First Submitted Date  ICMJE July 14, 2022
First Posted Date  ICMJE July 28, 2022
Last Update Posted Date July 28, 2022
Actual Study Start Date  ICMJE June 22, 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2022)
Change from baseline (Day -1) QTcF (ΔΔQTcF) following up to 24 hours post administration of a supratherapeutic dose of psilocybin. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2022)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: Up to 30 Days Post Dose ]
# of participants with TEAE following administration of psilocybin and moxifloxacin
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Evaluation of Psilocybin's Effect on Cardiac Repolarization
Official Title  ICMJE Thorough QT/QTc (TQT) Clinical Trial to Evaluate the Effect of Psilocybin on Cardiac Repolarization in Healthy Volunteers
Brief Summary The purpose of this study is to evaluate the effects of a supratherapeutic dose of psilocybin on cardiac repolarization.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE QTc Interval
Intervention  ICMJE
  • 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
  • Drug: Moxifloxacin
    The positive comparator used in this study is a 400 mg moxifloxacin tablet.
    Other Names:
    • Avelox
    • Moxeza
  • Drug: Micro-Crystalline Cellulose
    The placebo used in this study is encapsulated using a HPMC capsule and contains micro-crystalline cellulose.
Study Arms  ICMJE
  • Experimental: Treatment A (IP at therapeutic dose)
    A single therapeutic dose of psilocybin.
    Intervention: Drug: Psilocybin
  • Experimental: Treatment B (IP at supratherapeutic dose)
    A single supratherapeutic dose of psilocybin.
    Intervention: Drug: Psilocybin
  • Placebo Comparator: Treatment C (Placebo - Negative control)
    A single dose of placebo-to-match psilocybin MCC capsules.
    Intervention: Drug: Micro-Crystalline Cellulose
  • Active Comparator: Treatment D (Placebo - Positive control)
    A single 400 mg dose of moxifloxacin.
    Intervention: Drug: Moxifloxacin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 26, 2022)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Theraysa Gapasin, MS, aMFT 608-278-7662 ClinicalTrials@usonainstitute.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05478278
Other Study ID Numbers  ICMJE PSIL102-TQT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Usona Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Usona Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Charles Raison, MD Usona Institute
PRS Account Usona Institute
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP