[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627493":3},{"organization":4,"outcomesModule":7,"designInfo":58,"detailedDescription":67,"studyPopulation":57,"armGroups":68,"interventions":81,"overallOfficials":91,"centralContacts":95,"locations":100,"responsibleParty":119,"collaborators":122,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":57,"eligibilityCriteria":131,"healthyVolunteers":132,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":57,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":150,"whyStopped":57,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Yale University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":50,"otherOutcomes":57},[9,13,16,19,22,25,28,31,34,37,40,43,46,47],{"measure":10,"description":11,"timeFrame":12},"The Complex Working Memory Span (CWMS) Task- fMRI measure","CWMS Task assesses immediate plus delayed recall and working memory by assessing working memory capacity by presenting a list of stimuli to be recalled while simultaneously performing a secondary task. This task uses a fully crossed design which includes both same-domain CWMS conditions (e.g. verbal storage combined with verbal processing) as well as cross-domain CWMS conditions (e.g., verbal storage combined with spatial processing). BOLD signal Infrontal lobe.","From enrollment to end of treatment at 8 weeks.",{"measure":14,"description":15,"timeFrame":12},"NEO-Five-Factor-Inventory (NEO-FFI)","The NEO-FFI is a self-description questionnaire with 60 items for the measurement of the \"big five\": neuroticism, extraversion, openness, agreeableness, and consciousness. It uses a 5-point Likert scale ranging from \"completely disagree\" to \"fully agree.",{"measure":17,"description":18,"timeFrame":12},"Beck Depression Inventory","This scale has a total of 21 items. Each item is scored from 0-3 points, and the total score ranges from 0-63 points. The higher the score, the higher the degree of depression.",{"measure":20,"description":21,"timeFrame":12},"Beck Anxiety Inventory","Beck Anxiety Inventory is a 21-item self-reported questionnaire which measures the existenceand severity of symptoms of anxiety. Each of the 21 items on BAI tool represents an anxiety symptom. A total score of 0 - 7 is interpreted as a \"Minimal\" level of anxiety; 8 - 15 as \"Mild\"; 16 - 25 as \"Moderate\", and 26 - 63 as \"Severe\".",{"measure":23,"description":24,"timeFrame":12},"Harvard Flourishing Measure","12 questions, rating from 0 to 10 per question, sum score to calculate the 'flourish measure' will be used.",{"measure":26,"description":27,"timeFrame":12},"NIH Toolbox Cognitive Battery","Cognitive function will be assessed using the NIH Toolbox Cognition Battery, administered on an iPad.",{"measure":29,"description":30,"timeFrame":12},"Ecological Momentary Assessments (EMAs) w\u002F MindLamp","Once-daily questions (EMAs) about mood and sleep will be sent via the MindLamp smartphone app.",{"measure":32,"description":33,"timeFrame":12},"Switching Stroop Test","Stroop task measures response inhibition or response interference control. Participants will be shown a series of word colors that are either congruent or incongruent with the color of the word itself. The participant will be asked to respond to the color of the word and not the word itself. Responses are made with the keyboard. The incongruent condition is the more difficult condition of the two. Reaction time is recorded and a cost score is calculated, with shorter cost scores indicating better performance.",{"measure":35,"description":36,"timeFrame":12},"Penn Conditional Exclusion Test","Neurocognition measure of reasoning \\& problem solving in PennCNB. Scores will be transformed into z-scores. The key score will assess perseverative errors. Lowest score = 0, no max score. A higher score is correlated with worse performance, i.e. more perseverative errors.",{"measure":38,"description":39,"timeFrame":12},"Flanker Inhibitory Control and Attention Test","This test is designed to evaluate an individual's ability to concentrate their attention while inhibiting automatic response tendencies that could potentially hinder goal achievement. This is the percent correct outcome from this assessment.",{"measure":41,"description":42,"timeFrame":12},"Face Name Associated Memory Exam","The score ranges from 0 to 130, with a higher score indicating better speed of processing.",{"measure":44,"description":45,"timeFrame":12},"9-hole pegboard dexterity test","The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses. Time to complete the test as quickly as possible",{"measure":26,"description":45,"timeFrame":12},{"measure":48,"description":49,"timeFrame":12},"Neurite Orientation Dispersion and Density Imaging (NODDI)","Assessing synaptic plasticity in MRI",[51,54],{"measure":52,"description":53,"timeFrame":12},"Complex Working Memory Span task","Measures ability to juggle holding information (storage) and doing something with it (processing) at the same time. Percent accuracy will be reported.",{"measure":55,"description":56,"timeFrame":12},"fMRI","Mean BOLD signal",null,{"allocation":59,"interventionModel":60,"interventionModelDescription":57,"primaryPurpose":61,"observationalModel":57,"timePerspective":57,"maskingInfo":62},"RANDOMIZED","PARALLEL","BASIC_SCIENCE",{"masking":63,"maskingDescription":57,"whoMasked":64},"DOUBLE",[65,66],"PARTICIPANT","CARE_PROVIDER","This study is being conducted to evaluate the effects of 30 days of intermittently microdosed psilocybin in a parallel arm double-blind manner on mood, cognition, subjective well-being and structural\u002Ffunctional MRI compared to placebo, using validated psychological assessments and cognitive tests. 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.\n\nDemonstrating significant results in a population of healthy psychedelic non-users will establish a strong precedent for studying the effects of microdosing psychedelics in patient populations, such as those with treatment-resistant depression. Showing that microdosing minimizes risk of adverse outcomes with psychedelic treatment while maintaining beneficial effects would provide useful information relevant to clinical research in psychedelic-assisted psychotherapy. In addition to investigating claims that microdosing psychedelics may improve cognition and mood, this study also aims to test the hypothesis that these effects including those measurable at a brain level may persist beyond the course of the 30 days of the study. There are few to no studies that assessed the longevity of psychedelic effects on the majority of the above measures, so the proposed study may further establish the longer-term benefits of microdosing. The use of structural and functional magnetic resonance imaging (fMRI) will elucidate the mechanisms by which microdosing may be exerting its effects on mood and cognition. Because this is a relatively understudied area, information gleaned from this study will provide service in informing the field in general.",[69,75],{"label":70,"type":71,"description":72,"interventionNames":73},"Psychedelic group","ACTIVE_COMPARATOR","An imperceptible dose of psilocybin in capsules will be administered to subjects three times weekly for four weeks. Assessments will be conducted once weekly. After 30 days of a steady dose of psilocybin, subjects will be re-assessed with baseline measures.",[74],"Drug: Psliocybin",{"label":76,"type":77,"description":78,"interventionNames":79},"Placebo group","PLACEBO_COMPARATOR","An dose of placebo in capsules, identical to the active, will be administered to subjects three times weekly for four weeks. Assessments will be conducted once weekly. After 30 days of a steady dose of psilocybin, subjects will be re-assessed with baseline measures.",[80],"Drug: Placebo",[82,87],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":57},"DRUG","Psliocybin","2.0mg powdered psilocybin derived from Psilocybe cubensis mushrooms, in capsules, provided three times weekly for four weeks",[70],{"type":83,"name":88,"description":89,"armGroupLabels":90,"otherNames":57},"Placebo","0mg matching capsules, provided three times weekly for four weeks",[76],[92],{"name":93,"affiliation":5,"role":94},"Godfrey Pearlson, MD","PRINCIPAL_INVESTIGATOR",[96],{"name":93,"role":97,"phone":98,"phoneExt":57,"email":99},"CONTACT","860-545-7757","godfrey.pearlson@hhchealth.org",[101],{"facility":102,"status":57,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":114},"Olin Neuropsychiatry Research Center","Hartford","Connecticut","06106","United States","US",{"type":109,"coordinates":110},"Point",[111,112],-72.68509,41.76371,{"lat":112,"lon":111},[115],{"name":116,"role":97,"phone":117,"phoneExt":57,"email":118},"Diana King","860-545-7563","diana.king@hhchealth.org",{"type":94,"investigatorFullName":120,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":57,"oldOrganization":57},"Godfrey Pearlson","Professor of Psychiatry and Neuroscience, Founding Director Olin Neuropsychiatry Research Center",[123],{"name":124,"class":6},"Hartford HealthCare","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":137,"type":138},20,"ESTIMATED","INTERVENTIONAL",[141],"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.",[144],"Psychedelic Microdosing Effects on Mood, Cognition, Subjective Well-being and MRI",[146,147,148,55,149],"Psychedelics","Psilocybin","MRI","Microdosing","NOT_YET_RECRUITING","2026-09-22",{"date":153,"type":154},"2026-09-24","ACTUAL",{"date":156,"type":138},"2026-10-01",{"date":158,"type":138},"2028-04-01",{"name":5,"class":6},1]