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HealthyPhase 1NCT05467761

Bioavailability Study of Psilocybin in Normal Adults

A Phase 1 study testing Oral Psilocybin and IV Psilocybin in people with Healthy, run by University of Wisconsin, Madison at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Oral Psilocybin and IV Psilocybin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jun 2023to Mar 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Wisconsin

    Madison, Wisconsin, 53705

Other trials in United States

About this study

Official title: A Phase 1 Study Comparing the Pharmacokinetics and Safety of Intravenous and Oral Psilocybin

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.

Read the 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.

Conditions
Healthy
Being tested
Oral Psilocybin, IV Psilocybin
Keywords
psilocybin, psychedelics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral PsilocybinDrug

    25mg orally

  • IV PsilocybinDrug

    5mg intravenously

Study groups in NCT05467761
Study groupRoleWhat they receive
Oral and IV psilocybinExperimentalPsilocybin 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.
Receives: Drug: Oral Psilocybin; Drug: IV Psilocybin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the maximum concentration of psilocin following oral and IV administrations of psilocybin

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

    Measured: Day 8, Day 22

  2. Determine the concentration of psilocin following oral and IV administrations of psilocybin

    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.

    Measured: Day 8, Day 22

  3. Determine the concentration of psilocin following oral and IV administrations of psilocybin

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

    Measured: Day 8, Day 22

  4. Determine the concentration of psilocin following oral and IV administrations of psilocybin

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

    Measured: Day 8, Day 22

  5. Difference in the area under plasma concentration-time curve (AUC) between psilocybin administration methods.

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

    Measured: Day 8, Day 22

  6. Difference in the maximum concentration (Cmax) between psilocybin administration methods.

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

    Measured: Day 8, Day 22

  7. Difference in the time to maximum plasma concentration (Tmax) between psilocybin administration methods.

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

    Measured: Day 8, Day 22

Secondary outcomes (2)

  1. Characterize the incidence and severity of adverse events associated with doses of psilocybin in healthy adults

    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

    Measured: 12 weeks

  2. Suicidal ideation

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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2022
  2. Study startJun 2023 (estimated)
  3. Primary completionMar 2024 (estimated)
  4. Study completionMar 2024 (estimated)

Why it stopped: Sponsor was not financially able or willing to continue to support the study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05467761
Sponsor's protocol ID
2022-0612
Other IDs
A561000, PHARM/PHARMACY, 04/21/2022, 2022-0612
Status last verified
May 2023
First submitted
18 Jul 2022
Last updated
15 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oral Psilocybin and IV Psilocybin in people with Healthy, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the maximum concentration of psilocin following oral and IV administrations of psilocybin (time frame: Day 8, Day 22). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05467761.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.

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