[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psychedelic-microdosing-effects-on-mood-cognition-subjective-well-being-and-mri\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psychedelic-microdosing-effects-on-mood-cognition-subjective-well-being-and-mri":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100627493","early-phase-1-psilocybin-microdosing-on-cognition-mood-and-quality-of-life-100627493",false,"NCT07449351","Psilocybin Microdosing on Cognition, Mood and Quality of Life","Effects of Psilocybin Microdosing on Cognition, Mood and Quality of Life: A Pilot Study","Inclusion Criteria:\n\n* No history of psychedelic use OR\n* No use within 10 years, less than or equal to 7x in life OR\n* No use within 5 years, less than or equal to 3x in life\n* Able to read, speak, and understand English\n* Able and willing to provide written informed consent, and willing to commit to study protocol\n* Women of childbearing potential must be on a highly effective birth control method\n* Must have smartphone compatible with mindLAMP app\n\nExclusion Criteria:\n\n* Positive screen for recreational drugs or alcohol on test day will result in rescheduling the appointment\n* Current mood, developmental, or psychotic disorders (e.g., schizophrenia, affective disorders) per DSM-V\n* Current or past alcohol or substance use disorder per DSM-V\n* IQ \\\u003C70 on the Weschler Abbreviated Scale of Intelligence\n* Serious medical, neuro-ophthalmological, or neurological illness (e.g., cancer, seizure disorders, encephalopathy)\n* Current pregnancy, breastfeeding, or ineffective birth control methods\n* History of head trauma with loss of consciousness lasting \\>30 minutes or concussion in last 30 days\n* Any medical\u002Fneurological condition that could compromise neurocognitive performance (e.g., epilepsy, multiple sclerosis, fetal alcohol syndrome)\n* Anyone deemed unsafe to study personnel for any reason; e.g., suicidal ideation\n* Focal brain lesion seen on structural MRI\n* MRI contraindications (e.g., implanted metallic object, severe claustrophobia)\n* 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)\n* Currently taking a monoamine oxidase inhibitor, tricyclic antidepressant, other non-SSRI or non-SNRI antidepressants, an antipsychotic or a mood stabilizer\n* Family history of schizophrenia or schizoaffective disorder (first degree relatives), or bipolar disorder type 1 (first degree relatives)\n* Diagnosis of arrhythmia or ongoing cardiovascular disorder\n* 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\n* Clinically relevant abnormal laboratory results, 12-lead ECG, vital signs, cardiopulmonary compromise as detected by echocardiogram, or other physical findings\n* Presence of more than mild regurgitant lesions in any position and left ventricular ejection fraction \\\u003C 35 %\n* Evidence of pulmonary vascular disease demonstrated by right ventricular systolic pressure \\>30mmHg\n* Currently taking any GLP-1\n\nStudy Discontinuation Criteria\n\n* Development of active suicidal or homicidal ideation with plan and intent\n* Worsening in mood symptoms, or development of psychotic symptoms that in the opinion of the investigators requires discontinuation\n* Development of severe or life-threatening medical condition\n* Psychiatric or medical hospitalization or incarceration post-screening\n* 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)",true,"ALL","21 Years","55 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"EARLY_PHASE1","This study is being conducted to evaluate how of 30 days of intermittently microdosed psilocybin affects mood, cognition, subjective well-being and structural\u002Ffunctional 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.",[28],"Psychedelic Microdosing Effects on Mood, Cognition, Subjective Well-being and MRI",[30,31,32,33,34],"Psychedelics","Psilocybin","MRI","fMRI","Microdosing","NOT_YET_RECRUITING","2026-09-22",{"date":38,"type":39},"2026-09-24","ACTUAL",{"date":41,"type":22},"2026-10-01",{"date":43,"type":22},"2028-04-01",{"name":45,"class":46},"Yale University","OTHER"]