Bioavailability Study of Psilocybin in Normal Adults

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.

Intervention / Treatment

  • Oral Psilocybin (DRUG)
    25mg orally
  • IV Psilocybin (DRUG)
    5mg intravenously

Condition or Disease

  • Healthy

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Withdrawn
    Study results: No Results Available
    Age: 25 Years to 65 Years
    Enrollment: 0 (ACTUAL)
    Allocation: N/A
    Primary Purpose: Basic Science

    Masking

    Clinical Trial Dates

    Start date: Jun 01, 2023 ESTIMATED
    Primary Completion: Mar 01, 2024 ESTIMATED
    Completion Date: Mar 01, 2024 ESTIMATED
    Study First Posted: Jul 20, 2022 ACTUAL
    Last Updated: May 11, 2023

    Sponsors / Collaborators

    Lead Sponsor: University of Wisconsin, Madison
    Lead sponsor is responsible party
    Responsible Party: N/A

    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.

    Participant Groups

    • 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 25
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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 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 half-life of psilocin in plasma following a single IV dose as compared to that following a single oral dose.

    • Determine the AUC of psilocin in plasma following a single IV dose as compared to that following a single oral dose.

    • AUC will be determined after oral and IV psilocybin doses to assess for more consistent blood concentration.

    • Cmax will be determined after oral and IV psilocybin doses to assess for more consistent blood concentration.

    • Tmax will be determined after oral and IV psilocybin doses to assess for more consistent blood concentration.

    Secondary Outcomes

    • 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

    • Assessed using the Columbia - Suicide Severity Rating Scale (C-SSRS) at every in-person visit

    More Details

    NCT Number: NCT05467761
    Other IDs: 2022-0612
    Study URL: https://clinicaltrials.gov/study/NCT05467761
    Last updated: Sep 29, 2023