[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07180108":3,"trial-entities:NCT07180108":250,"trial-summary:NCT07180108":254},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":64,"secondary_outcomes":121,"sex":178,"minimum_age":179,"maximum_age":180,"healthy_volunteers":181,"eligibility_criteria":182,"std_ages":214,"locations":217,"central_contacts":227,"overall_officials":228,"references":232,"see_also_links":246},"NCT07180108","IRB00372917","PRoMiSS: Psilocybin and the Role of Music in Set and Setting","ENROLLING_BY_INVITATION","2028-08","2025-09","2025-09-18","2025-08-12","Johns Hopkins University","OTHER",false,"The goal of this clinical trial is to understand how personally meaningful, autobiographically salient music compares to standardized playlists when combined with psilocybin in healthy adults ages 21 to 75. The main questions it aims to answer are:\n\nDoes autobiographically salient music lead to stronger emotional responses to music, greater acute subjective effects, and more lasting improvements in mood, affect, and well-being compared to standardized or ambient playlists?\n\nHow are brain and body responses - including EEG activity, respiration, heart rate, and skin conductance - influenced by autobiographically salient music under psilocybin?\n\nDo brain and body responses to specific music features differ when the music is autobiographically salient compared to non-salient playlists?\n\nResearchers will compare five music conditions: three conditions where an 80-minute block of autobiographically salient music is placed at different points in the 6-hour psilocybin session (0-80 minutes, 80-160 minutes, or 240-320 minutes), a standardized Johns Hopkins psilocybin playlist, and an ambient playlist with no autobiographical content.\n\nParticipants will:\n\n* Take a single oral dose of psilocybin (25 mg) during one study session\n* Listen to one of the five music conditions while reclining in a comfortable setting\n* Complete questionnaires about emotions, acute, subjective effects, insight, etc.\n* Undergo EEG and physiological monitoring (respiration, heart rate, skin conductance) during the session\n* Complete MRI brain scans before the session and 1 week after psilocybin\n* Return for follow-ups at 1 day, 1 week, and 1 month after psilocybin\n* At 1 month, complete a qualitative interview and a nondrug EEG music listening session, where the participant's hear either music from the participant's own psilocybin session or music from another participant's session","Classic psychedelics such as psilocybin reliably alter consciousness, producing changes in perception, emotion, and meaning-making. Music has long been recognized as an important component of psychedelic therapy, serving to guide the experience and shape its trajectory. However, little is known about how different types of music influence outcomes, particularly music that is personally meaningful to participants.\n\nThis study will investigate the effects of autobiographically salient (AS) music compared to standardized playlists during high-dose psilocybin sessions. The goal is to understand how personally relevant music modulates acute subjective experiences, emotional responses, and longer-term psychological outcomes. In addition, the study will examine brain and body responses to music under psilocybin, including how these responses differ when music is autobiographically salient.\n\nThe central questions are whether AS music enhances emotional depth, psychological insight, and well-being more than non-autobiographical playlists, and whether the timing of AS music during the session influences these effects. Participants will be followed up after the psilocybin session to assess both short-term and longer-term outcomes, including well-being, mood, and meaning-making.\n\nThis trial represents one of the first controlled investigations into how personalized music contributes to the therapeutic potential of psychedelics. Findings may help optimize music-based interventions in psychedelic therapy and improve understanding of the role of music in shaping altered states of consciousness.",[18,19],"Psilocybin","Music Intervention",[18,21,22,23,24,25,26,27],"Set and Setting","Music Cognition","Music-evoked autobiographical memory","Emotion","Altered State of Consciousness","Psychedelics","Memory","INTERVENTIONAL","BASIC_SCIENCE",[31],"PHASE1",{"count":33,"type":34},100,"ESTIMATED",[36,46,51,55,58,61],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":42},"DRUG","Psilocybin (high dose)","25 mg pill",[41],"6 hour playlist of music",[43,44,45],"DMF#037635 (Type II)","Purisys LLC","Psilocybin Drug Substance",{"type":47,"name":48,"description":49,"armGroupLabels":50},"BEHAVIORAL","Playlist 1","Six hour playlist",[41],{"type":47,"name":52,"description":53,"armGroupLabels":54},"Playlist 2","A six hour playlist",[41],{"type":47,"name":56,"description":53,"armGroupLabels":57},"Playlist 3",[41],{"type":47,"name":59,"description":53,"armGroupLabels":60},"Playlist 4",[41],{"type":47,"name":62,"description":53,"armGroupLabels":63},"Playlist 5",[41],[65,69,73,76,79,83,87,91,94,97,100,103,106,109,112,115,118],{"measure":66,"description":67,"timeFrame":68},"Challenging Experiences Questionnaire","The Challenging Experience Questionnaire (CEQ) is a self-report measure designed to assess the intensity and quality of difficult or distressing experiences during psychedelic states.\n\nZero is equivalent to no challenging experiences and 5 is an extreme (more than ever before in my life). Higher CEQ = \"more difficult.\" That's generally worse for safety and usually not what predicts the best clinical gains.","Immediately at the end of their experimental session",{"measure":70,"description":71,"timeFrame":72},"Psychological Insight Questionnaire (PIQ)","The Psychological Insight Questionnaire (PIQ) is a validated self-report measure developed to assess psychological insight experiences following a psychedelic session. It was designed to capture the extent to which individuals gain meaningful self-related or therapeutic insights during and after acute psychedelic states.\n\nThe PIQ is scored 0 (not at all) to 6 Extremely (more than ever before in my life). A higher score is associated with better outcomes.","Immediately at end of experimental session",{"measure":74,"description":75,"timeFrame":72},"Core Flow State Scale (C-FSS)","The Core Flow State Scale (CFSS) is a validated self-report measure designed to assess the subjective experience of flow, the psychological state of deep absorption, enjoyment, and optimal engagement in an activity.\n\nThe CFSS is scored from 1 (Strongly Disagree) to 5 (Strongly Agree). A higher score is better.",{"measure":77,"description":78,"timeFrame":72},"Mystical Experiences Questionnaire (MEQ-30)","The Mystical Experience Questionnaire (MEQ) is the most widely used measure for assessing the phenomenological features of mystical-type experiences occasioned by psychedelics.\n\nThe MEQ is measured from 0 (not at all) to 5 extreme (ore than ever before in my life and stronger than 4). A higher MEQ score is associated with better outcomes.",{"measure":80,"description":81,"timeFrame":82},"Experience of Unity (11D-ASC)","A sense of oneness with the environment or the universe, dissolving boundaries between self and world.\n\nThe 11D-ASC is a self-report questionnaire designed to assess the phenomenology of altered states of consciousness induced by psychedelics and other methods (e.g., meditation, sensory deprivation). There are 11 dimensions.\n\nQuestions are scored from 0 (No, not more than usual) to 100 (Yes, much more than usual). Higher Experience of Unity scores are generally better","Immediately after experimental session",{"measure":84,"description":85,"timeFrame":86},"Change in EEG oscillatory power across canonical frequency bands (µV²\u002FHz)","EEG - spectral analysis - Electroencephalography (EEG) is a non-invasive neuroimaging method that measures the brain's electrical activity via electrodes placed on the scalp.\n\nChange in EEG oscillatory power across canonical frequency bands (delta, theta, alpha, beta, gamma) during music listening under psilocybin. Analyses will be conducted at the scalp sensor level using Statistical Parametric Mapping, version 12 (SPM12).\n\nGroup-level contrasts of oscillatory power changes (µV²\u002FHz) across music conditions","During experimental session up to 10 hours",{"measure":88,"description":89,"timeFrame":90},"Music Ratings: Autobiographical Salience","Ratings of autobiographical salience for each song. Autobiographical salience is scored from 0 (none) to 4 (extremely autobiographically salient). More autobiographically salient music is thought to be better.","1-day following experimental session and immediately post 1-month EEG music listening session",{"measure":92,"description":93,"timeFrame":82},"Spiritual Experience - Altered States of Consciousness (ASC-11D)","Feelings of sacredness, transcendence, or contact with a higher reality.\n\nThe 11D-ASC is a self-report questionnaire designed to assess the phenomenology of altered states of consciousness induced by psychedelics and other methods (e.g., meditation, sensory deprivation). There are 11 dimensions.\n\nQuestions are scored from 0 (No, not more than usual) to 100 (Yes, much more than usual). Higher Spiritual Experience scores are generally better.",{"measure":95,"description":96,"timeFrame":82},"Blissful State (11D-ASC)","Intense feelings of happiness, peace, and contentment.\n\nThe 11D-ASC is a self-report questionnaire designed to assess the phenomenology of altered states of consciousness induced by psychedelics and other methods (e.g., meditation, sensory deprivation). There are 11 dimensions.\n\nQuestions are scored from 0 (No, not more than usual) to 100 (Yes, much more than usual). Higher Blissful State scores are generally better.",{"measure":98,"description":99,"timeFrame":82},"Insightfulness (11D-ASC)","Deep personal or existential insights, perceived understanding of self or reality.\n\nThe 11D-ASC is a self-report questionnaire designed to assess the phenomenology of altered states of consciousness induced by psychedelics and other methods (e.g., meditation, sensory deprivation). There are 11 dimensions.\n\nQuestions are scored from 0 (No, not more than usual) to 100 (Yes, much more than usual). Higher Insightfulness scores are generally better.",{"measure":101,"description":102,"timeFrame":82},"Disembodiment (11D-ASC)","Altered sense of the body, including floating, detachment, or out-of-body experiences.\n\nThe 11D-ASC is a self-report questionnaire designed to assess the phenomenology of altered states of consciousness induced by psychedelics and other methods (e.g., meditation, sensory deprivation). There are 11 dimensions.\n\nQuestions are scored from 0 (No, not more than usual) to 100 (Yes, much more than usual). Disembodiment scores are generally neutral or ambivalent. Mild forms may support ego dissolution and positive outcomes, but extreme disembodiment sometimes predicts challenging experiences.",{"measure":104,"description":105,"timeFrame":82},"Impaired Cognition & Control (11D ASC)","Difficulty thinking clearly, controlling thoughts, or performing tasks.\n\nThe 11D-ASC is a self-report questionnaire designed to assess the phenomenology of altered states of consciousness induced by psychedelics and other methods (e.g., meditation, sensory deprivation). There are 11 dimensions.\n\nQuestions are scored from 0 (No, not more than usual) to 100 (Yes, much more than usual). Higher Impaired Cognition and Control are generally linked with confusion and less therapeutic benefit.",{"measure":107,"description":108,"timeFrame":82},"Anxiety (11D-ASC)","Fear, unease, or paranoid thoughts during the experience.\n\nThe 11D-ASC is a self-report questionnaire designed to assess the phenomenology of altered states of consciousness induced by psychedelics and other methods (e.g., meditation, sensory deprivation). There are 11 dimensions.\n\nQuestions are scored from 0 (No, not more than usual) to 100 (Yes, much more than usual). Higher Anxiety is generally linked with lower acute well-being, though may sometimes precede later benefit if well-supported.",{"measure":110,"description":111,"timeFrame":82},"Complex Imagery (11D-ASC)","Vivid, detailed visual imagery of objects, scenes, or entities.\n\nThe 11D-ASC is a self-report questionnaire designed to assess the phenomenology of altered states of consciousness induced by psychedelics and other methods (e.g., meditation, sensory deprivation). There are 11 dimensions.\n\nQuestions are scored from 0 (No, not more than usual) to 100 (Yes, much more than usual). Complex Imagery is generally neutral. Vivid imagery contributes to meaningfulness but is not a consistent predictor of therapeutic change.",{"measure":113,"description":114,"timeFrame":82},"Elementary Imagery (11D-ASC)","Simple visual patterns such as colors, shapes, or geometric forms.\n\nThe 11D-ASC is a self-report questionnaire designed to assess the phenomenology of altered states of consciousness induced by psychedelics and other methods (e.g., meditation, sensory deprivation). There are 11 dimensions.\n\nQuestions are scored from 0 (No, not more than usual) to 100 (Yes, much more than usual). Elementary Imagery is generally neutral. It is a common perceptual effect of psilocybin but is not strongly tied to long-term outcomes.",{"measure":116,"description":117,"timeFrame":82},"Audio-Visual Synesthesia (11D-ASC)","Cross-modal experiences, such as hearing colors or seeing sounds.\n\nThe 11D-ASC is a self-report questionnaire designed to assess the phenomenology of altered states of consciousness induced by psychedelics and other methods (e.g., meditation, sensory deprivation). There are 11 dimensions.\n\nQuestions are scored from 0 (No, not more than usual) to 100 (Yes, much more than usual). Audio-Visual Synesthesia is generally neutral. It is an interesting phenomenology, but has weak association with outcomes.",{"measure":119,"description":120,"timeFrame":82},"Changed Meaning of Percepts (11D-ASC)","Altered interpretation of ordinary sensory stimuli, often with symbolic or novel significance.\n\nThe 11D-ASC is a self-report questionnaire designed to assess the phenomenology of altered states of consciousness induced by psychedelics and other methods (e.g., meditation, sensory deprivation). There are 11 dimensions.\n\nQuestions are scored from 0 (No, not more than usual) to 100 (Yes, much more than usual). Changed Meaning of Percepts can be positive or negative. It can enhance therapeutic meaning and insight (positive), but in some cases may drive paranoia or misinterpretation (negative).",[122,126,130,134,138,142,146,149,153,156,159,162,165,168,171,174],{"measure":123,"description":124,"timeFrame":125},"Brain Activity measured by Blood Oxygenation Level Dependent signal","Functional Magnetic Resonance Imaging (fMRI) is a non-invasive neuroimaging technique that measures brain activity by detecting changes in blood oxygenation (BOLD signal), which reflects local neural activity.\n\nWe will be measuring a change in BOLD signal between the pre-experiment (preparation 2) and 1-week post-experiment. The main contrasts will include:\n\n* Pre vs Post (all music)\n* Pre vs Post (Autobiographically Salient music)\n* Pre vs. Post (JHC playlist music)\n* Pre vs Post (AMB playlist music)","At Preparation Session 2 (before experimental session) and 1-week post experimental session",{"measure":127,"description":128,"timeFrame":129},"Joyful Activation (GEMS-Joy)","Cheerfulness, enthusiasm, vitality, dancing or movement impulses\n\nThe Geneva Emotional Music Scale (GEMS) is a validated, music-specific instrument designed to measure the range of emotions evoked by music.\n\nGEMS is scored from 0 (not at all) to 4 (extremely).\n\nA higher Joyful Activation score is generally positive and liked to pleasurable absorption and well-being.","1-day after experimental session",{"measure":131,"description":132,"timeFrame":133},"Trait Impulsivity Questionnaire (BIS-11)","The Barratt Impulsiveness Scale (BIS-11) is one of the most widely used self-report instruments for assessing trait impulsivity.\n\nThe BIS-11 is scored from 0 (Rarely\u002FNever) to 3 (Almost Always\u002FAlways). Generally lower impulsivity is better.","Preparation (pre experiment), 1-week post experimental session, and 1-month post experimental session",{"measure":135,"description":136,"timeFrame":137},"Core Dispositional Flow Scale (C DFS)","The Core Dispositional Flow Scale (CDFS) is a brief, validated self-report instrument designed to measure an individual's general tendency to experience flow across activities and contexts.\n\nThe CDFS is measured from 1 (never) to 5 (always). A higher score is generally better.","Preparation (pre experiment), 1-week post experimental session, and 1-month post post experimental session",{"measure":139,"description":140,"timeFrame":141},"Satisfaction With Life Scale (SWLS)","The Satisfaction With Life Scale (SWLS) is a brief self-report instrument designed to measure global cognitive judgments of one's overall life satisfaction.\n\nThe SWLS is measured from 1 (strongly disagree) to 7 (strongly agree). A higher score is better.","Preparation (baseline), 1-week post experimental session , and 1-month post experimental session",{"measure":143,"description":144,"timeFrame":145},"Big Five Inventory - 10 items (BFI-10)","The Big Five Inventory-10 (BFI-10) is a short, validated self-report instrument designed to measure the five major dimensions of personality with minimal participant burden.\n\nThe BFI-10 is measured from 1-Disagree strongly to 5-Agree Strongly. Depending on the personality dimension a higher (e.g., openness) or lower (e.g., neuroticism) score can be better.","Preparation (baseline), 1-week post experimental session and 1-month post experimental session",{"measure":147,"description":148,"timeFrame":145},"Behavioral Activation and Inhibition (BAI)","The Behavioral Inhibition System (BIS) and Behavioral Activation System (BAS) Scales are self-report measures designed to assess individual differences in sensitivity to punishment and reward, based on Gray's Reinforcement Sensitivity Theory of personality.\n\nThe BIS\u002FBAS is measured from 1-Strongly disagree to 4- Strongly agree. Usually balance between BIS and BAS is considered most adaptive. Neither is better or worse, universally.",{"measure":150,"description":151,"timeFrame":152},"Barcelona Music Reward Questionnaire (BMRQ)","The Barcelona Music Reward Questionnaire (BMRQ) is a 20-item self-report scale that assesses individual differences in the sensitivity to music-induced reward across five domains: Musical Seeking, Emotion Evocation, Mood Regulation, Social Reward, and Sensory-Motor responses. Scores are summed within each domain and can also be aggregated into a global score.\n\nThe BMRQ is measured from 1 (Completely disagree) to 5 (Completely agree). Generally a higher score is better, reflecting stronger emotional, motivational, and social responses to musical experience.","Preparation (baseline), 1-week post experimental session and 1-month post experimental session.",{"measure":154,"description":155,"timeFrame":129},"Wonder (GEMS-Wonder)","Feelings of awe, amazement, transcendence in response to music\n\nThe Geneva Emotional Music Scale (GEMS) is a validated, music-specific instrument designed to measure the range of emotions evoked by music.\n\nGEMS is scored from 0 (not at all) to 4 (extremely).\n\nA higher Wonder score is strongly aligned with mystical-type experiences and positive outcomes in psilocybin research (e.g., meaning, connectedness)",{"measure":157,"description":158,"timeFrame":129},"Transcendence (GEMS-Transcendence)","Spiritual uplift, timelessness, and \"beyond-the-self\" states\n\nThe Geneva Emotional Music Scale (GEMS) is a validated, music-specific instrument designed to measure the range of emotions evoked by music.\n\nGEMS is scored from 0 (not at all) to 4 (extremely).\n\nA higher Transcendence score is closely tied to beneficial mystical experiencers and long-term well-being gains.",{"measure":160,"description":161,"timeFrame":129},"Tenderness (GEMS-Tenderness)","Warmth, empathy, affection, emotional closeness\n\nThe Geneva Emotional Music Scale (GEMS) is a validated, music-specific instrument designed to measure the range of emotions evoked by music.\n\nGEMS is scored from 0 (not at all) to 4 (extremely).\n\nA higher Tenderness score supports prosocial feelings and can lead to increased compassion and positive social outcomes.",{"measure":163,"description":164,"timeFrame":129},"Peacefulness (GEMS-Peacefulness)","Calmness, relaxation, inner quiet.\n\nThe Geneva Emotional Music Scale (GEMS) is a validated, music-specific instrument designed to measure the range of emotions evoked by music.\n\nGEMS is scored from 0 (not at all) to 4 (extremely).\n\nA higher Peacefulness score is associated with positive acute states, reduced anxiety, and therapeutic benefit under supportive conditions.",{"measure":166,"description":167,"timeFrame":129},"Power (GEMS-Power)","Strong, energetic, dominant feelings of drive or determination\n\nThe Geneva Emotional Music Scale (GEMS) is a validated, music-specific instrument designed to measure the range of emotions evoked by music.\n\nGEMS is scored from 0 (not at all) to 4 (extremely).\n\nPower can be positive and support motivation and agency but is not consistently linked to psilocybin outcomes; sometimes associated with intensity that can become challenging. P",{"measure":169,"description":170,"timeFrame":129},"Tension (GEMS-Tension)","Unease, restlessness, suspense, emotional strain.\n\nThe Geneva Emotional Music Scale (GEMS) is a validated, music-specific instrument designed to measure the range of emotions evoked by music.\n\nGEMS is scored from 0 (not at all) to 4 (extremely).\n\nHigh Tension scores are often associated with challenging experiences and negative acute outcomes, though mild tension may precede later therapeutic insights.",{"measure":172,"description":173,"timeFrame":129},"Sadness (GEMS-Sadness)","Unease, restlessness, suspense, emotional strain.\n\nThe Geneva Emotional Music Scale (GEMS) is a validated, music-specific instrument designed to measure the range of emotions evoked by music.\n\nGEMS is scored from 0 (not at all) to 4 (extremely).\n\nSadness can be cathartic and meaning-enhancing but excessive sadness may contribute to difficult experiences.",{"measure":175,"description":176,"timeFrame":177},"Negative-Affect Composite Factor (STAI, DASS-21, POMS Total Mood Disturbance, PANAS-Negative Affect)","Composite index of negative mood\u002Faffect derived from four validated self-report measures:\n\nState-Trait Anxiety Inventory (STAI) : 0-3 per item; lower is better.\n\nDepression, Anxiety, Stress (DASS-21), 0-3 per item; lower is better.\n\nProfile of Mood States (POMS)-Total Mood Disturbance (TMD): 0-4 per item; lower TMD is better.\n\nPositive and Negative Affect Schedule (PANAS)-Negative Affect (NA) subscale: 0-4 per item; lower NA is better.","Baseline; Pre-session; 1-day post-session; 1-week post-session; 1-month post-session; 1-day follow-up after the 1-month assessment.","ALL","21 Years","75 Years",true,{"inclusion":183,"exclusion":198,"raw_text":213},[184,185,186,187,188,189,190,191,192,193,194,195,196,197],"• Fluent in English","No hearing impairment","Right-handed","Have a screening weight ≥ 40 kg (88.18 lbs) with BMI ≥16.","Be medically stable as determined by screening for medical problems via a personal interview, a medical history, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests","Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he\u002Fshe consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, he\u002Fshe must agree not to do so on session days.","Agree to refrain from using any psychoactive drugs within 24 hours of each drug administration. The exceptions are caffeine and nicotine, which can be consumed before arriving for drug administration sessions.","Agree not to take any as needed (PRN) medications on the mornings of drug sessions","Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.","Agree not to use any hair conditioner 24-hours before EEG sessions (Visits 3, 4, and 7)","Females of child-bearing potential must agree to use highly effective methods of contraception (defined as use of an intrauterine device, vaginal ring, or implanted or oral hormonal contraceptives) during the study","Agree that for one week before each drug session, he\u002Fshe will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti- inflammatory drugs, and common doses of vitamins and minerals.","Have limited lifetime use of hallucinogens, if any (the following criteria are preferred: no use in the past 5 years; total hallucinogen use less than 10 times)","Proof of COVID-19 vaccination.",[199,200,201,202,203,204,205,206,207,208,209,210,211,212],"• Unusually low reward response to music (defined as a majority of responses of \"1\" on the BMRQ)","Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing highly effective means of contraception","Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged corrected QT interval (QTc) interval (i.e., QTc \\> 450 msec), artificial heart valve, or transient ischemic attack (TIA) in the past year","Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia","Currently taking psychoactive prescription medication on a regular (e.g., daily) basis - exceptions may be made at the discretion of the study team physician for participants taking medications with short half-life if participants are able to abstain from taking the medication during session days (e.g. methylphenidate taken for attention or hyperactivity)","Currently taking on a regular (e.g., daily) basis any medications that have a primary centrally-acting serotonergic effect, including Monoamine Oxidase Inhibitors (MAOIs). For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.","Current or past history of meeting Diagnostic and Statistical Manual (DSM-5) criteria for schizophrenia spectrum or other psychotic disorders (except substance\u002Fmedication-induced or due to another medical condition), or Bipolar I Disorder","Current or history within one year of meeting DSM-5 criteria for a moderate or severe substance use disorder. If a nicotine user, consuming the equivalent of more than 10 cigarettes per day.","Have a first-degree relative with schizophrenia spectrum or other psychotic disorders, or bipolar disorder with mania (except substance\u002Fmedication-induced or due to another medical condition)","Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin","History of a medically significant suicide attempt as assessed by a study team clinician","Standard MRI contraindications: head trauma, claustrophobia incompatible with scanning, contraindicated medical devices, prior history as a metal worker and\u002For certain metallic objects in the body -- must complete MRI screening form and be approved by MRI technologist before each scan","History of migraine.","History of angiotensin-converting enzyme inhibitor (ACEi) angioedema","Inclusion Criteria:\n\n* • Fluent in English\n\n  * No hearing impairment\n  * Right-handed\n  * Have a screening weight ≥ 40 kg (88.18 lbs) with BMI ≥16.\n  * Be medically stable as determined by screening for medical problems via a personal interview, a medical history, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests\n  * Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he\u002Fshe consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, he\u002Fshe must agree not to do so on session days.\n  * Agree to refrain from using any psychoactive drugs within 24 hours of each drug administration. The exceptions are caffeine and nicotine, which can be consumed before arriving for drug administration sessions.\n  * Agree not to take any as needed (PRN) medications on the mornings of drug sessions\n  * Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.\n  * Agree not to use any hair conditioner 24-hours before EEG sessions (Visits 3, 4, and 7)\n  * Females of child-bearing potential must agree to use highly effective methods of contraception (defined as use of an intrauterine device, vaginal ring, or implanted or oral hormonal contraceptives) during the study\n  * Agree that for one week before each drug session, he\u002Fshe will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti- inflammatory drugs, and common doses of vitamins and minerals.\n  * Have limited lifetime use of hallucinogens, if any (the following criteria are preferred: no use in the past 5 years; total hallucinogen use less than 10 times)\n  * Proof of COVID-19 vaccination.\n\nExclusion Criteria:\n\n* • Unusually low reward response to music (defined as a majority of responses of \"1\" on the BMRQ)\n\n  * Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing highly effective means of contraception\n  * Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged corrected QT interval (QTc) interval (i.e., QTc \\> 450 msec), artificial heart valve, or transient ischemic attack (TIA) in the past year\n  * Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia\n  * Currently taking psychoactive prescription medication on a regular (e.g., daily) basis - exceptions may be made at the discretion of the study team physician for participants taking medications with short half-life if participants are able to abstain from taking the medication during session days (e.g. methylphenidate taken for attention or hyperactivity)\n  * Currently taking on a regular (e.g., daily) basis any medications that have a primary centrally-acting serotonergic effect, including Monoamine Oxidase Inhibitors (MAOIs). For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.\n  * Current or past history of meeting Diagnostic and Statistical Manual (DSM-5) criteria for schizophrenia spectrum or other psychotic disorders (except substance\u002Fmedication-induced or due to another medical condition), or Bipolar I Disorder\n  * Current or history within one year of meeting DSM-5 criteria for a moderate or severe substance use disorder. If a nicotine user, consuming the equivalent of more than 10 cigarettes per day.\n  * Have a first-degree relative with schizophrenia spectrum or other psychotic disorders, or bipolar disorder with mania (except substance\u002Fmedication-induced or due to another medical condition)\n  * Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin\n  * History of a medically significant suicide attempt as assessed by a study team clinician\n  * Standard MRI contraindications: head trauma, claustrophobia incompatible with scanning, contraindicated medical devices, prior history as a metal worker and\u002For certain metallic objects in the body -- must complete MRI screening form and be approved by MRI technologist before each scan\n  * History of migraine.\n  * History of angiotensin-converting enzyme inhibitor (ACEi) angioedema",[215,216],"ADULT","OLDER_ADULT",[218],{"facility":219,"city":220,"state":221,"zip":222,"country":223,"geoPoint":224},"Center for Psychedelics and Consciousness Research in the Behavioral Biology Research Center","Baltimore","Maryland","21224","United States",{"lat":225,"lon":226},39.29038,-76.61219,[],[229],{"name":230,"affiliation":12,"role":231},"Frederick S Barrett, PhD","PRINCIPAL_INVESTIGATOR",[233,237,240,243],{"pmid":234,"type":235,"citation":236},"28790944","BACKGROUND","Barrett FS, Robbins H, Smooke D, Brown JL, Griffiths RR. Qualitative and Quantitative Features of Music Reported to Support Peak Mystical Experiences during Psychedelic Therapy Sessions. Front Psychol. 2017 Jul 25;8:1238. doi: 10.3389\u002Ffpsyg.2017.01238. eCollection 2017.",{"pmid":238,"type":235,"citation":239},"20515227","Barrett FS, Grimm KJ, Robins RW, Wildschut T, Sedikides C, Janata P. Music-evoked nostalgia: affect, memory, and personality. Emotion. 2010 Jun;10(3):390-403. doi: 10.1037\u002Fa0019006.",{"pmid":241,"type":235,"citation":242},"29396616","Kaelen M, Giribaldi B, Raine J, Evans L, Timmerman C, Rodriguez N, Roseman L, Feilding A, Nutt D, Carhart-Harris R. The hidden therapist: evidence for a central role of music in psychedelic therapy. Psychopharmacology (Berl). 2018 Feb;235(2):505-519. doi: 10.1007\u002Fs00213-017-4820-5. Epub 2018 Feb 2.",{"pmid":244,"type":235,"citation":245},"35138585","Golden TL, Magsamen S, Sandu CC, Lin S, Roebuck GM, Shi KM, Barrett FS. Effects of Setting on Psychedelic Experiences, Therapies, and Outcomes: A Rapid Scoping Review of the Literature. Curr Top Behav Neurosci. 2022;56:35-70. doi: 10.1007\u002F7854_2021_298.",[247],{"label":248,"url":249},"Center for Psychedelics and Consciousness Research website","https:\u002F\u002Fhopkinspsychedelic.org\u002Fmusicstudy",{"nct_id":4,"conditions":251,"biomarkers":253},[252],"Healthy Volunteers",[],{"nct_id":4,"found":14,"summary":255,"prompt_version":255},null]