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Bioavailability Study of Psilocybin in Normal Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05467761
Recruitment Status : Not yet recruiting
First Posted : July 20, 2022
Last Update Posted : July 20, 2022
Sponsor:
Collaborator:
TRYP Therapeutics
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE July 18, 2022
First Posted Date  ICMJE July 20, 2022
Last Update Posted Date July 20, 2022
Estimated Study Start Date  ICMJE October 2022
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2022)
  • Determine the maximum concentration of psilocin following oral and IV administrations of psilocybin [ Time Frame: Day 8, Day 22 ]
    Determine the maximum plasma concentration of psilocin in plasma following a single IV dose as compared to that following a single oral dose.
  • Determine the concentration of psilocin following oral and IV administrations of psilocybin [ Time Frame: Day 8, Day 22 ]
    Determine the time to maximum plasma concentration of psilocin in plasma following a single IV dose as compared to that following a single oral dose.
  • Determine the concentration of psilocin following oral and IV administrations of psilocybin [ Time Frame: Day 8, Day 22 ]
    Determine the half-life of psilocin in plasma following a single IV dose as compared to that following a single oral dose.
  • Determine the concentration of psilocin following oral and IV administrations of psilocybin [ Time Frame: Day 8, Day 22 ]
    Determine the AUC of psilocin in plasma following a single IV dose as compared to that following a single oral dose.
  • Difference in the area under plasma concentration-time curve (AUC) between psilocybin administration methods. [ Time Frame: Day 8, Day 22 ]
    AUC will be determined after oral and IV psilocybin doses to assess for more consistent blood concentration.
  • Difference in the maximum concentration (Cmax) between psilocybin administration methods. [ Time Frame: Day 8, Day 22 ]
    Cmax will be determined after oral and IV psilocybin doses to assess for more consistent blood concentration.
  • Difference in the time to maximum plasma concentration (Tmax) between psilocybin administration methods. [ Time Frame: Day 8, Day 22 ]
    Tmax will be determined after oral and IV psilocybin doses to assess for more consistent blood concentration.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2022)
  • Characterize the incidence and severity of adverse events associated with doses of psilocybin in healthy adults [ Time Frame: 12 weeks ]
    The incidence and severity of expected and unexpected adverse events will be collected using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
  • Suicidal ideation [ Time Frame: 12 weeks ]
    Assessed using the Columbia - Suicide Severity Rating Scale (C-SSRS) at every in-person visit
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 Bioavailability Study of Psilocybin in Normal Adults
Official Title  ICMJE A Phase 1 Study Comparing the Pharmacokinetics and Safety of Intravenous and Oral Psilocybin
Brief Summary The purpose of this research study is to compare an oral dose of psilocybin and an intravenous (IV) infusion of psilocybin to assess differences in how the drug is absorbed by the body, the psychedelic experience, and any side effects when taken by healthy adult participants. Participants can expect to be in the study for approximately 12 weeks.
Detailed Description Psilocybin, when delivered to screened and prepared participants in a controlled environment, has shown strong evidence of positive effects in treating cancer-related psychiatric distress, depression and anxiety, treatment-resistant depression, and nicotine or alcohol addiction. Psilocybin therapy is generally safe and well-tolerated when conducted under controlled conditions. Psilocybin is very rapidly transformed to the active metabolite psilocin, which is considered the active agent from psilocybin administration. Oral and IV psilocybin are expected to have similar pharmacokinetic and psychedelic effects, as well as safety profiles, while IV psilocybin will achieve more consistent blood levels than are possible with oral psilocybin.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Oral Psilocybin
    25mg orally
  • Drug: IV Psilocybin
    5mg intravenously
Study Arms  ICMJE Experimental: Oral and IV psilocybin
Psilocybin with psychological support: Psilocybin will be administered in the form of capsules, taken orally with water, at one visit. Psilocybin will be administered through IV at the other visit.
Interventions:
  • Drug: Oral Psilocybin
  • Drug: IV Psilocybin
Publications * Not Provided

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2022)
8
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Overall healthy and medically stable, as determined by screening
  • Capable of giving signed informed consent
  • Negative urine pregnancy test in persons of childbearing potential

Exclusion Criteria:

  • Have any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, prior myocardial infarction, tachycardia, artificial heart valve, corrected QT interval (QTc) >450 msec at screening, any other clinically significant screening ECG abnormality, or any other significant cardiovascular condition
  • Presence of a gastrointestinal disease that could interfere with absorption of an orally administered drug
  • Have epilepsy
  • Positive urine drug test
  • Prior adverse effects from psilocybin or other psychedelics that required hospitalization
  • Currently taking on a regular basis (e.g., daily) any medications having a primary centrally acting serotonergic effect, including selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), or serotonin-acting dietary supplements (such as 5-hydroxy-tryptophan or St. John's wort)
  • Currently taking prohibited medications, including antihypertensive medications, UGT1A9 or 1A10 inhibitors (e.g., regorafenib, rifampicin, phenytoin, eltrombopag, mefenamic acid, diflunisal, niflumic acid, sorafenib, isavuconazole, deferasiroxor, ginseng), and aldehyde or alcohol dehydrogenase inhibitors (e.g,, disulfiram)
  • Participation in another concurrent clinical study; or use of investigational drugs, biologics, or devices within 30 days prior to assignment of study drug administration order
  • Anyone who is pregnant, lactating, or planning on becoming pregnant during the study
  • Unwilling to withhold prohibited concomitant medications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Protea Research protea.research@mailplus.wisc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05467761
Other Study ID Numbers  ICMJE 2022-0612
A561000 ( Other Identifier: UW Madison )
PHARM/PHARMACY ( Other Identifier: UW Madison )
04/21/2022 ( Other Identifier: UW Madison )
2022-0612 ( Other Identifier: UW Madison )
Has Data Monitoring Committee Yes
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: No
Current Responsible Party University of Wisconsin, Madison
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Wisconsin, Madison
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE TRYP Therapeutics
Investigators  ICMJE
Principal Investigator: Christopher Nicholas, PhD University of Wisconsin, Madison
Principal Investigator: Paul Hutson, PharmD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date July 2022

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