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Consciousness and Psilocybin Effects on Well-Being: Pilot Phase (CoPE Pilot)

Adaptive, non-randomised Phase I healthy volunteer study (target n=15) testing IV psilocybin 2 mg (2‑ or 10‑minute infusions) with or without 0.2 mg oral clonidine to identify regimens that permit dosing during sleep.

Target Enrollment
15 participants
Study Type
Phase I interventional
Design
Non-randomized, single Blind

Detailed Description

This adaptive sequential study evaluates IV psilocybin 2 mg administered over 2 or 10 minutes, with and without 0.2 mg oral clonidine, to determine whether dosing can be delivered to sleeping participants without awakening them.

Initial asleep cohorts receive placebo and active conditions; progression criteria determine move to awake comparator cohorts. Wake dosing may include comparisons with and without clonidine; psychosocial integration sessions follow each dosing visit.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

2-min asleep

experimental

2 mg IV psilocybin over 2 minutes with 0.2 mg oral clonidine or saline while asleep (overnight visits).

Interventions

  • Psilocybin2 mg
    via IV• single dose

    IV infusion over 2 minutes

  • Compound
    via Oral• single dose

    Clonidine 0.2 mg oral given as pre-treatment

  • Placebo
    via IV• single dose

    Saline placebo IV 10 mL over matched infusion time

2-min awake

experimental

2 mg IV psilocybin over 2 minutes with 0.2 mg oral clonidine in awake participants (if progression criteria met).

Interventions

  • Psilocybin2 mg
    via IV• single dose

    IV infusion over 2 minutes

  • Compound
    via Oral• single dose

    Clonidine 0.2 mg oral

10-min asleep

experimental

2 mg IV psilocybin over 10 minutes with 0.2 mg oral clonidine or saline while asleep (alternate initial group).

Interventions

  • Psilocybin2 mg
    via IV• single dose

    IV infusion over 10 minutes

  • Compound
    via Oral• single dose

    Clonidine 0.2 mg oral

  • Placebo
    via IV• single dose

    Saline placebo IV 10 mL over matched infusion time

10-min awake

experimental

2 mg IV psilocybin over 10 minutes with 0.2 mg oral clonidine in awake participants (if progression criteria met).

Interventions

  • Psilocybin2 mg
    via IV• single dose

    IV infusion over 10 minutes

  • Compound
    via Oral• single dose

    Clonidine 0.2 mg oral

2-min psilocybin alone

active comparator

2 mg IV psilocybin over 2 minutes in awake participants (comparison without clonidine).

Interventions

  • Psilocybin2 mg
    via IV• single dose

    IV infusion over 2 minutes

10-min psilocybin alone

active comparator

2 mg IV psilocybin over 10 minutes in awake participants (comparison without clonidine).

Interventions

  • Psilocybin2 mg
    via IV• single dose

    IV infusion over 10 minutes

Participants

Ages
18 – 45
Sexes
Male & Female

Inclusion Criteria

  • Medically healthy
  • English-speaking
  • Live within 150 miles of Madison, WI for duration of study

Exclusion Criteria

  • Current use of medications that may interact with psilocybin
  • Current sleep disorder, including (but not limited to) insomnia, sleep apnea, restless legs syndrome, and/or narcolepsy
  • Females with positive urine pregnancy at any time point during screening or study participation
  • Current cardiac valve disease

Study Details

Locations

University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

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