Clinical TrialHealthy VolunteersPsilocybinPsilocybinWithdrawn

Bioavailability Study of Psilocybin in Normal Adults

Open-label Phase I single-group study (n=8) comparing oral (25 mg) and IV (5 mg) psilocybin in healthy adults to assess bioavailability, subjective effects and safety.

Target Enrollment
8 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

This study compares a single oral 25 mg dose and a single 5 mg intravenous infusion of psilocybin in healthy, screened adults to evaluate pharmacokinetic differences, psychedelic subjective effects and safety.

Each participant receives both routes in separate visits with psychological support; IV dosing is expected to give more consistent blood levels than oral dosing.

Participants are involved for approximately 12 weeks including screening, dosing visits and follow-up assessments.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Oral and IV psilocybin

experimental

Crossover single-group: each participant receives one oral (25 mg) session and one IV (5 mg) session with psychological support.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    25 mg capsule, single oral session

  • Psilocybin5 mg
    via IV• single dose• 1 doses total

    5 mg intravenous infusion, single session

Participants

Ages
25 – 65
Sexes
Male & Female

Inclusion Criteria

  • 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

  • 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

Study Details

Locations

University of Wisconsin — Madison, Wisconsin, United States

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