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The RECAP2 Study: Midazolam and Psilocybin

This triple-blind, randomised, placebo-controlled trial (n=60) will study the role of neuroplasticity in the behavioural effects of psilocybin in individuals with mild declines in emotional wellbeing. Participants will receive one of four medication combinations (25 mg or 1 mg psilocybin with IV midazolam or IV saline).

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

Detailed Description

The study randomises 60 participants to one of four parallel arms combining higher- or very-low-dose psilocybin (25 mg or 1 mg, oral) with either IV midazolam or IV saline; the primary aim is to probe neuroplasticity mechanisms underlying behavioural effects.

Assessments include MRI, TMS, EEG and questionnaires to measure neural and behavioural markers of wellbeing; midazolam is used to induce amnesia of the psychedelic experience without oversedation.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

25 mg Psilocybin + Midazolam

experimental

Psilocybin (25 mg) + IV midazolam

Interventions

  • Psilocybin25 mg
    via Oral• single dose
  • Compound
    via IV• single dose

    IV midazolam to induce amnesia; dosing per protocol

25 mg Psilocybin + Saline

experimental

Psilocybin (25 mg) + IV saline (placebo for midazolam)

Interventions

  • Psilocybin25 mg
    via Oral• single dose
  • Placebo
    via IV• single dose

    IV saline (placebo for midazolam)

1 mg Psilocybin + Midazolam

experimental

Psilocybin (1 mg/control) + IV midazolam

Interventions

  • Psilocybin1 mg
    via Oral• single dose
  • Compound
    via IV• single dose

    IV midazolam to induce amnesia; dosing per protocol

1 mg Psilocybin + Saline

experimental

Psilocybin (1 mg/control) + IV saline

Interventions

  • Psilocybin1 mg
    via Oral• single dose
  • Placebo
    via IV• single dose

    IV saline (placebo for midazolam)

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Age 18 to 65 years at screening, of any identified gender and racial/ethnic group
  • Physically healthy; does not meet criteria for an exclusionary medical condition
  • English-speaking (able to provide consent and complete questionnaires)
  • Modest decrement in self-reported wellbeing without the presence of a DSM-5 Axis I mood or anxiety disorder
  • Able to undergo magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS)

Exclusion Criteria

  • Exclusion Criteria:
  • Exclusionary DSM-5 psychiatric diagnosis and/or active suicidal ideation
  • Exclusionary medical conditions
  • Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)
  • Clinically significant electrocardiogram (ECG)
  • Use of psychotropic or CNS-altering medications within 3 months of screening
  • Hypertension or tachycardia

Study Details

Locations

UW School of Medicine and Public Health — Madison, Wisconsin, United States

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