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Not yet recruitingEarly Phase 1

Psilocybin Microdosing on Cognition, Mood and Quality of Life

NCT07449351 · Yale University

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
20
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

This study is being conducted to evaluate how of 30 days of intermittently microdosed psilocybin affects mood, cognition, subjective well-being and structural/functional MRI results compared to a placebo. Investigators hypothesize that compared to placebo, 30 days of intermittently microdosed psilocybin will produce observable changes in mood, cognition, subjective well-being and MRI, in the absence of psychedelic experiences.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • The Complex Working Memory Span (CWMS) Task- fMRI measure

    Measured over From enrollment to end of treatment at 8 weeks.

  • NEO-Five-Factor-Inventory (NEO-FFI)

    Measured over From enrollment to end of treatment at 8 weeks.

  • Beck Depression Inventory

    Measured over From enrollment to end of treatment at 8 weeks.

  • Beck Anxiety Inventory

    Measured over From enrollment to end of treatment at 8 weeks.

  • Harvard Flourishing Measure

    Measured over From enrollment to end of treatment at 8 weeks.

  • NIH Toolbox Cognitive Battery

    Measured over From enrollment to end of treatment at 8 weeks.

  • Ecological Momentary Assessments (EMAs) w/ MindLamp

    Measured over From enrollment to end of treatment at 8 weeks.

  • Switching Stroop Test

    Measured over From enrollment to end of treatment at 8 weeks.

  • Penn Conditional Exclusion Test

    Measured over From enrollment to end of treatment at 8 weeks.

  • Flanker Inhibitory Control and Attention Test

    Measured over From enrollment to end of treatment at 8 weeks.

  • Face Name Associated Memory Exam

    Measured over From enrollment to end of treatment at 8 weeks.

  • 9-hole pegboard dexterity test

    Measured over From enrollment to end of treatment at 8 weeks.

  • NIH Toolbox Cognitive Battery

    Measured over From enrollment to end of treatment at 8 weeks.

  • Neurite Orientation Dispersion and Density Imaging (NODDI)

    Measured over From enrollment to end of treatment at 8 weeks.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 40 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * No history of psychedelic use * Able to read, speak, and understand English * Able and willing to provide written informed consent, and willing to commit to study protocol * Women of childbearing potential must be on a highly effective birth control method Exclusion Criteria: * Positive screen for recreational drugs or alcohol on test day will result in rescheduling the appointment * Current mood, developmental, or psychotic disorders (e.g., schizophrenia, affective disorders) per DSM-V * Current or past alcohol or substance use disorder per DSM-V * IQ \<70 on the Weschler Abbreviated Scale of Intelligence * Serious medical, neuro-ophthalmological, or neurological illness (e.g., cancer, seizure disorders, encephalopathy) * Current pregnancy, breastfeeding, or ineffective birth control methods * History of head trauma with loss of consciousness lasting \>30 minutes or concussion in last 30 days * Any medical/neurological condition that could compromise neurocognitive performance (e.g., epilepsy, multiple sclerosis, fetal alcohol syndrome) * Anyone deemed unsafe to study personnel for any reason; e.g., suicidal ideation * Focal brain lesion seen on structural MRI * MRI contraindications (e.g., implanted metallic object, severe claustrophobia)

Where

1 study site

FacilityCityRegionCountry
Olin Neuropsychiatry Research CenterHartfordConnecticutUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07449351 on ClinicalTrials.gov →

Last updated in the registry 2026-06-23. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

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