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UW Psilocybin Pharmacokinetics Study

Phase I single-group pharmacokinetics study (n=12) of oral psilocybin in healthy adults, ascending doses 0.3 → 0.45 → 0.6 mg/kg with attended dosing and overnight sampling.

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

Detailed Description

This Phase I study determined the pharmacokinetics of an extemporaneous oral psilocybin formulation in healthy adults to support later phase trials in clinical populations.

Participants received three single-dose psilocybin administrations (0.3, 0.45, 0.6 mg/kg) separated by a minimum of four weeks; each session included an attended 0–8 hour outpatient period and overnight 8–24 hour sampling in the clinical research unit.

Safety monitoring included 12-lead ECGs at specified time points, continuous attendance by two trained monitors during drug action, and physician availability throughout the 24 hour observation period; blood and urine samples were collected for PK analyses.

Study Protocol

Preparation

sessions

Dosing

3 sessions
1440 min each

Integration

sessions

Study Arms & Interventions

Psilocybin (ascending)

experimental

Single-group, within-subject ascending-dose psilocybin (0.3 → 0.45 → 0.6 mg/kg) with ≥4 weeks between sessions; attended dosing with overnight observation.

Interventions

  • Psilocybin0.3 mg/kg
    via Oral• single dose

    ≈20 mg per 70 kg

  • Psilocybin0.45 mg/kg
    via Oral• single dose

    ≈30 mg per 70 kg; given ≥4 weeks after dose 1

  • Psilocybin0.6 mg/kg
    via Oral• single dose

    ≈40 mg per 70 kg; given ≥4 weeks after dose 2

Participants

Ages
21 – 80
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:\n\n* Aged 21 - 80 years\n* Able to read, speak, and understand spoken English\n* Self-report of at least one prior positive hallucinogen drug experience that included a meaningful altered state of consciousness (eg psilocybin, LSD, or other classic hallucinogens)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0\n* Women of childbearing potential must agree to effective contraception through 90 days after last dose; documentation of method required\n* Ability and willingness to adhere to study requirements, attend all visits, preparatory and follow-up sessions, and complete evaluations\n* Agree to refrain from psychoactive drugs, including alcohol and tobacco, within 24 hours of each administration (caffeine excepted)\n* Non-smokers

Exclusion Criteria

  • Exclusion Criteria:\n\n* Estimated creatinine clearance <30 ml/min (Cockcroft Gault)\n* Clinically significant abnormal chemistry or hematologic values per site reference intervals\n* Positive urine pregnancy for females of childbearing potential at screening or day of first treatment\n* Clinically significant abnormalities on physical exam\n* Inadequately treated hypertension (systolic >140 mmHg or diastolic >90 mmHg)\n* Personal history of primary psychotic disorder, bipolar I or II, or schizophrenia (unless substance-induced or due to medical condition)\n* First- or second-degree family history of primary psychotic disorder, bipolar I or II, or schizophrenia\n* Substance abuse or dependency within past five years\n* Suicidal ideation or attempt within past 30 days and/or any prior suicidal ideation/attempt that study physician/PI deem makes participant unsuitable\n* Urine drug test positive for non-prescribed drugs of abuse at screening or day of first treatment; urine cannabinoid >50 ng/ml suggestive of heavy use is exclusionary\n* Current use of MAO inhibitors or dopaminergic antagonists (must have stopped ≥5x elimination half-life)\n* Lack of a local support person available during 24 h treatment/observation period\n* Concurrent or recent (within 5 years) history of major depression, OCD, panic disorder, anorexia nervosa, or bulimia nervosa\n* Poor venous access\n* Known acute coronary syndrome or angina, evidence of ischemic disease or ventricular arrhythmias on ECG, or conduction defects on screening ECG\n* Cardiac transplantation\n* Lactose intolerance (psilocybin capsule excipient)\n* Type I or insulin-dependent Type II diabetes\n* Prescription medicine requiring dosing during the 8 hours of drug action\n* Current or recent (past 5 years) seizure disorder\n* Chronic or frequent migraines\n* Regular or frequent benzodiazepine use\n* ADHD/ADD\n* Regular or frequent stimulant use\n* Generalized Anxiety Disorder (GAD)\n* PTSD\n* Use of neuroleptic medications\n* Any physical or psychological symptom or medication use that, in the clinical judgment of the study physician, makes the participant unsuitable

Study Details

Locations

University of Wisconsin, School of Pharmacy — Madison, Wisconsin, United States

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