Midazolam with psilocybin for mild declines in emotional wellbeing
Role of Experience, Conscious Awareness, and Plasticity in Psilocybin's Behavioral Effects - Follow-Up Study (The RECAP 2 Study)
PHASE1 · University of Wisconsin, Madison · NCT06692192
This trial will see if different doses of psilocybin, given with midazolam or placebo, can boost emotional wellbeing in adults who have experienced a modest drop in wellbeing.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Wisconsin, Madison (other) |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT06692192 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional study will give adults aged 18–65 one of four medication combinations combining two psilocybin doses with either midazolam or placebo. Participants will undergo MRI, transcranial magnetic stimulation with EEG, and complete questionnaires before and after dosing to measure changes in neuroplasticity and wellbeing. The goal is to link biological measures of brain plasticity with short-term behavioral changes following psilocybin exposure. Safety labs, ECG, and psychiatric screening are used to exclude participants with medical or DSM-5 psychiatric conditions.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults 18–65 who are physically healthy, not taking psychotropic medications, have a modest self-reported decline in wellbeing without a DSM-5 mood or anxiety disorder, and can undergo MRI and TMS.
Not a fit: Patients with active DSM-5 psychiatric diagnoses, recent use of psychotropic/CNS medications, uncontrolled medical issues such as hypertension or tachycardia, or inability to undergo MRI/TMS are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the study could identify dosing and neuroplasticity-related mechanisms that improve emotional wellbeing and guide future therapeutic use of psilocybin.
How similar studies have performed: Previous psilocybin studies have shown benefits for depression and wellbeing, but combining midazolam as an active comparator and explicitly probing neuroplasticity in people with modest wellbeing decline is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madison, Wisconsin
- UW School of Medicine and Public Health — Madison, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Charles Raison, MD — University of Wisconsin, Madison
- Study coordinator: RECAP Study Contact
- Email: recap2@psychiatry.wisc.edu
- Phone: 608-263-4852
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Psilocybin, sub-optimal wellbeing