Midazolam with psilocybin for mild declines in emotional wellbeing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Psilocybin in Alcohol Use Disorder with Depression (Relapse Prevention)

  This study tests whether higher-dose psilocybin-assisted psychotherapy helps prevent relapse in adults with severe alcohol use disorder and depressive symptoms after detox.

  Recruiting Phase 3 Centre Hospitalier Universitaire de Nīmes · Bayonne and 7 other locations · NCT07638553

• Autobiographically meaningful music with psilocybin to shape set and setting

  This study tests whether personally meaningful music, compared with standard playlists, changes the emotional experience and mood effects of psilocybin in healthy adults aged 21 to 75.

  Recruiting Phase 1 Johns Hopkins University · Baltimore, Maryland · NCT07180108

• Psilocybin-assisted therapy for anxiety and depression in advanced cancer patients

  This study is testing if therapy combined with psilocybin can help advanced cancer patients who are feeling anxious or depressed feel better and improve their quality of life.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT06200155

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.