Psilocybin for Emotional Wellbeing Decline

Overseen By Laura McCormick

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Wisconsin, Madison

Must not be taking: Psychotropic, CNS-altering

Disqualifiers: Psychiatric diagnosis, Suicidal ideation, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Charles Raison, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for physically healthy, English-speaking individuals who feel a mild decline in emotional wellbeing but do not have a diagnosed mood or anxiety disorder. Participants must be able to consent and complete questionnaires.

Inclusion Criteria

I can speak English and fill out forms.

I feel a bit worse lately but don't have a diagnosed mood or anxiety disorder.

I am physically healthy with no major medical conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of four possible combinations of psilocybin and midazolam or placebo, undergo MRI, complete questionnaires, and undergo TMS and EEG

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in wellbeing and other psychological measures

28 days

Multiple assessments (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Midazolam
• Psilocybin

Trial Overview The study tests different doses of psilocybin combined with either midazolam or placebo to see which improves wellbeing. It involves one medication session, an MRI scan, questionnaires, TMS, and EEG monitoring.

How Is the Trial Designed?

Group I: Group 4: Psilocybin and IV saline Experimental Treatment 2 Interventions

Psilocybin (1 mg/control) + IV saline

Group II: Group 3: Psilocybin and IV midazolam Experimental Treatment 2 Interventions

Psilocybin (1 mg/control) + IV midazolam

Group III: Group 2: Psilocybin and IV saline Experimental Treatment 2 Interventions

Psilocybin (25 mg) + IV saline (placebo for midazolam)

Group IV: Group 1: Psilocybin and intravenous (IV) midazolam Experimental Treatment 2 Interventions

Psilocybin (25 mg) + IV midazolam

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Vail Health Foundation

Collaborator

Trials

1

Recruited

60+