Phase 1: testing Psilocybin for Psilocybin
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 dummy treatment (placebo) to see what dose induces increased wellbeing.
Official registry: https://clinicaltrials.gov/study/NCT06692192 · University of Wisconsin, Madison · enrollment listed as 60
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Psilocybin, Psilocybin, or Midazolam. The registry lists allocation as randomized. 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.
They plan to enroll about 60 people at Madison. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Role of Experience, Conscious Awareness, and Plasticity in Psilocybin's Behavioral Effects - Follow-Up Study (The RECAP 2 Study)
Interventions: Psilocybin, Psilocybin, Midazolam, Saline
Primary outcome (registry wording): Change in Warwick-Edinburgh Mental wellbeing Scale (WEMWBS)
Who it is for (from inclusion criteria)
- Ages 18 Years to 65 Years
- 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
- 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)
Who the registry excludes
- 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:
Public study contact (from the registry)
RECAP Study Contact
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- UW School of Medicine and Public Health — Madison, Wisconsin (recruiting)
FAQ about this NCT record
Is NCT06692192 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06692192?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06692192?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary