The RECAP2 Study: Midazolam and Psilocybin

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT06692192
Phase
PHASE1
Status
Recruiting
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Conditions

  • Psilocybin

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Psilocybin — DRUG
    25mg of psilocybin
  • Psilocybin — DRUG
    1mg of psilocybin
  • Midazolam — DRUG
    The goal of the midazolam dosing regimen is to induce amnesia of the psychedelic experience without inducing over-sedation during the dosing session.
  • Saline — DRUG
    Saline will be administered as a placebo for midazolam

Study Details

The goal of this clinical trial is to learn about the role that inducing neuroplasticity (the brain's ability to adapt and change) plays in the behavioral effects of psilocybin in people who have experienced a mild decline in emotional wellbeing. Researchers will compare different doses of psilocybin combined with midazolam or placebo to see what dose induces increased wellbeing. Participants will: * Receive one of four possible combinations of medications * Undergo an MRI * Complete questionnaires * Undergo transcranial magnetic stimulation (TMS) and EEG

Key Dates

Start date
Aug 7, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group 1: Psilocybin and intravenous (IV) midazolam
    Psilocybin (25 mg) + IV midazolam
  • Experimental: Group 2: Psilocybin and IV saline
    Psilocybin (25 mg) + IV saline (placebo for midazolam)
  • Experimental: Group 3: Psilocybin and IV midazolam
    Psilocybin (1 mg/control) + IV midazolam
  • Experimental: Group 4: Psilocybin and IV saline
    Psilocybin (1 mg/control) + IV saline

Primary Outcome Measure

Change in Warwick-Edinburgh Mental wellbeing Scale (WEMWBS) [ Time Frame: Baseline to 7 days post-dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UW School of Medicine and Public HealthMadisonWisconsin53792-

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UW School of Medicine and Public Health· Madison, WI

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