Not Yet RecruitingEarly Phase 1psilocybin

Psilocybin Microdosing on Cognition, Mood and Quality of Life

Sponsored by Yale University

NCT ID
NCT07449351
Target Enrollment
20 participants
Start Date
2026-10-01
Est. Completion
2028-04-01

About This Study

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.

Conditions Studied

Psychedelic Microdosing Effects on Mood, Cognition, Subjective Well-being and MRI

Interventions

  • •Psliocybin
  • •Placebo

Eligibility

Age:21 Years - 55 Years
Healthy Volunteers:Yes
View full eligibility criteria
Inclusion Criteria:

* No history of psychedelic use OR
* No use within 10 years, less than or equal to 7x in life OR
* No use within 5 years, less than or equal to 3x in life
* 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
* Must have smartphone compatible with mindLAMP app

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)
* Clinically significant risk of suicidality, as determined by a score of 4 or higher on the suicidal ideation subscale of C-SSRS (past 6 months) or any suicidal behavior (lifetime)
* Currently taking a monoamine oxidase inhibitor, tricyclic antidepressant, other non-SSRI or non-SNRI antidepressants, an antipsychotic or a mood stabilizer
* Family history of schizophrenia or schizoaffective disorder (first degree relatives), or bipolar disorder type 1 (first degree relatives)
* Diagnosis of arrhythmia or ongoing cardiovascular disorder
* Sustained clinically relevant abnormal heart rate (resting supine heart rate \>100 bpm) or blood pressure (resting supine sustolic blood pressure (SBP) above 140mmHg or diastolic blood pressure (DBP) above 90mmHg) at screening
* Clinically relevant abnormal laboratory results, 12-lead ECG, vital signs, cardiopulmonary compromise as detected by echocardiogram, or other physical findings
* Presence of more than mild regurgitant lesions in any position and left ventricular ejection fraction \< 35 %
* Evidence of pulmonary vascular disease demonstrated by right ventricular systolic pressure \>30mmHg
* Currently taking any GLP-1

Study Discontinuation Criteria

* Development of active suicidal or homicidal ideation with plan and intent
* Worsening in mood symptoms, or development of psychotic symptoms that in the opinion of the investigators requires discontinuation
* Development of severe or life-threatening medical condition
* Psychiatric or medical hospitalization or incarceration post-screening
* Adverse reaction to study drug that in the opinion of the investigators requires discontinuation (e.g. acute, clinically significant hypertension, cardiac toxicity, non-acute significant negative psychological changes)

Study Locations (1)

Olin Neuropsychiatry Research Center
Hartford, Connecticut, United States

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source