MedTrace Logo

The RECAP2 Study: Midazolam and Psilocybin

NCT06692192 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-03

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Psilocybin

25mg of psilocybin

DRUG

Psilocybin

1mg of psilocybin

DRUG

Midazolam

The goal of the midazolam dosing regimen is to induce amnesia of the psychedelic experience without inducing over-sedation during the dosing session.

DRUG

Saline

Saline will be administered as a placebo for midazolam

Sponsors & Collaborators

  • Vail Health Foundation

    collaborator UNKNOWN

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Charles Raison, MD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-07
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06692192 on ClinicalTrials.gov