Clinical TrialHealthy VolunteersPsilocybinPsilocybinPsilocybinActive not recruiting

Comparing the Effects of Psilocin and Psilocybin in Healthy Adults

Randomised, triple-masked, crossover Phase I study (n=20) comparing oral psilocin (17.5 mg), sublingual psilocin (2.18–4.36 mg), and oral psilocybin (25 mg) in healthy adults with preparatory and integration sessions.

Target Enrollment
20 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

This is a randomized, triple-masked, within-subject crossover study in 20 healthy adults comparing physiological and psychological effects of oral psilocin, sublingual psilocin, and oral psilocybin across multiple supervised dosing sessions.

Participants undergo baseline assessments, preparatory visits with trained facilitators, supervised dosing with clinician safety monitoring, and post-session integration; procedures may be repeated up to three additional times per participant.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocin vs Psilocybin

experimental

Within-subject crossover: oral psilocin, sublingual psilocin, and oral psilocybin in randomized order; possible additional sublingual session for some participants.

Interventions

  • Psilocybin17.5 mg
    via Oral• single dose

    Oral psilocin 17.5 mg with psychological support and monitoring.

  • Psilocybin25 mg
    via Oral• single dose

    Oral psilocybin 25 mg with psychological support and monitoring.

  • Psilocybin4.36 mg
    via Sublingual• single dose

    Sublingual psilocin range 2.18–4.36 mg (upper value shown); some participants may receive a second sublingual session.

Participants

Ages
25 – 50
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:\n\n* Age 25 to 50\n* Comfortable speaking and writing in English\n* Commit to attending all study visits and remote data collection tasks\n* No planned surgeries during the study\n* Had at least one prior experience with a psychedelic substance\n* Generally mentally and physically healthy\n* Agree to abstain from THC, CBD, or nicotine products during study

Exclusion Criteria

  • Exclusion Criteria:\n\n* Participated in another clinical trial within 30 days of entry to this trial\n* Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, N-methyl-D-aspartate (NMDAR) antagonists, antipsychotics, and stimulants\n* A health condition that makes study unsafe or unfeasible, determined by study physicians

Study Details

Locations

University of California, San Francisco — San Francisco, California, United States

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