NCT06692192 The RECAP2 Study: Midazolam and Psilocybin
| NCT ID | NCT06692192 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Wisconsin, Madison |
| Condition | Psilocybin |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-08-07 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2025-08-07 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 * Volunteer for an open-label follow-up phase of study
Eligibility 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: * 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 Participants invited to participate in the 28-day open label follow-up phase will: 1. Fully complete all activities associated with the randomized phase, including the virtual Day 84 assessment, before being approached about participation in the open label phase. 2. Participants who meet stopping criteria during the randomized phase are not eligible to enroll in the open label phase. 3. Participants who withdraw from the randomized phase are not eligible to enroll in the open label phase. 4. Enrollment into the open label phase must occur in the following sequence: 1. participants who have fully completed the randomized phase are screened for eligibility; 2. eligible participants meet with the study team and provide informed consent for the open label phase; 3. baseline eligibility is reassessed to confirm that participation in the open label phase remains appropriate and safe. The Principal Investigator may decline or defer open-label enrollment when unresolved concerns make participation unsafe or scientifically inappropriate.
Contact & Investigator
Charles Raison, MD
PRINCIPAL INVESTIGATOR
University of Wisconsin, Madison
Frequently Asked Questions
Who can join the NCT06692192 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Psilocybin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06692192 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06692192 currently recruiting?
Yes, NCT06692192 is actively recruiting participants. Contact the research team at recap2@psychiatry.wisc.edu for enrollment information.
Where is the NCT06692192 trial being conducted?
This trial is being conducted at Madison, United States.
Who is sponsoring the NCT06692192 clinical trial?
NCT06692192 is sponsored by University of Wisconsin, Madison. The principal investigator is Charles Raison, MD at University of Wisconsin, Madison. The trial plans to enroll 60 participants.