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CompletedPhase 1

Pilot RECAP Study in Healthy Volunteers

NCT04842045 · RECAP · University of Wisconsin, Madison

Closed to entry
Status
Not accepting participants
Phase 1
Phase
8
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The primary objective of the RECAP Study Program is to investigate the role played by conscious experience in the antidepressant effects of the psychedelic agent psilocybin. This pilot dosing study (PILOT RECAP) is designed to determine the optimal dose of midazolam that allows a psychedelic experience to occur while inducing amnesia for the experience. This is an essential step required for subsequent evaluation of the role of memory for the psychedelic experience in the antidepressant effects of psilocybin in the full RECAP study.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Number of participants scoring >50 percent of normative scores on selected questions from the Altered States of Consciousness (ASC) questionnaire asked during the dosing session Day 0.

    Measured over On Day 14

  • Number of participants scoring < 50 percent on post-dosing Day 1 of the mean normative score of ASC data from healthy volunteers administered the ASC questionnaire post-dosing

    Measured over On Day 15

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Age 21 to 65 years at screening * Medically healthy (does not meet criteria for an exclusionary medical condition) * No current DSM-5 psychiatric diagnosis * No current use of psychotropic medications * Ability/willingness to complete all study activities * Use of acceptable contraceptive methods (sexually active males and women of childbearing potential) * Speaks and reads English * No use of psychedelic drugs within prior 3 months of dosing visit * Able to swallow oral medications Exclusion Criteria: * Pregnancy * Current exclusionary medical illness * Current DSM-5 psychiatric diagnosis and/or suicidal thoughts/behavior within prior 12 months * Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis) * Clinically significant electrocardiogram (ECG) * Hypertension or tachycardia * First degree relative(s) with a history of schizophrenia, schizophreniform disorder, bipolar I disorder, bipolar II disorder, major depressive disorder with psychotic features

Where

1 study site

FacilityCityRegionCountry
UWHealth, 600 Highland AvenueMadisonWisconsinUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04842045 on ClinicalTrials.gov →

Last updated in the registry 2023-05-19. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

All 10 trials from University of Wisconsin, Madison →