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NCT07180108

PRoMiSS: Psilocybin and the Role of Music in Set and Setting

Enrolling by Invitation
PHASE1Ages 21–75InterventionalBasic science
Johns Hopkins University
~100 participants
Updated 2025-09-18 on ClinicalTrials.gov
What's tested:Psilocybin (high dose)Playlist 1Playlist 2Playlist 3Playlist 4Playlist 5

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Challenging Experiences Questionnaire
Measured over Immediately at the end of their experimental session
+16 more outcomes measured

Conditions

Psilocybin
Music Intervention

Explore related trials

Healthy Volunteers

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Frederick S Barrett, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

• 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/she 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/she 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/she 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.

Exclusion

• 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/medication-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/medication-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/or 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

What this trial measures

  • Challenging Experiences QuestionnaireImmediately at the end of their experimental session

    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. Zero 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.

  • Psychological Insight Questionnaire (PIQ)Immediately at end of experimental session

    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. The 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.

  • Core Flow State Scale (C-FSS)Immediately at end of experimental session

    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. The CFSS is scored from 1 (Strongly Disagree) to 5 (Strongly Agree). A higher score is better.

  • Mystical Experiences Questionnaire (MEQ-30)Immediately at end of experimental session

    The Mystical Experience Questionnaire (MEQ) is the most widely used measure for assessing the phenomenological features of mystical-type experiences occasioned by psychedelics. The 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.

  • Experience of Unity (11D-ASC)Immediately after experimental session

    A sense of oneness with the environment or the universe, dissolving boundaries between self and world. The 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. Questions are scored from 0 (No, not more than usual) to 100 (Yes, much more than usual). Higher Experience of Unity scores are generally better

  • Change in EEG oscillatory power across canonical frequency bands (µV²/Hz)During experimental session up to 10 hours

    EEG - spectral analysis - Electroencephalography (EEG) is a non-invasive neuroimaging method that measures the brain's electrical activity via electrodes placed on the scalp. Change 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). Group-level contrasts of oscillatory power changes (µV²/Hz) across music conditions

  • Music Ratings: Autobiographical Salience1-day following experimental session and immediately post 1-month EEG music listening session

    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.

  • Spiritual Experience - Altered States of Consciousness (ASC-11D)Immediately after experimental session

    Feelings of sacredness, transcendence, or contact with a higher reality. The 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. Questions are scored from 0 (No, not more than usual) to 100 (Yes, much more than usual). Higher Spiritual Experience scores are generally better.

  • Blissful State (11D-ASC)Immediately after experimental session

    Intense feelings of happiness, peace, and contentment. The 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. Questions are scored from 0 (No, not more than usual) to 100 (Yes, much more than usual). Higher Blissful State scores are generally better.

  • Insightfulness (11D-ASC)Immediately after experimental session

    Deep personal or existential insights, perceived understanding of self or reality. The 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. Questions are scored from 0 (No, not more than usual) to 100 (Yes, much more than usual). Higher Insightfulness scores are generally better.

  • Disembodiment (11D-ASC)Immediately after experimental session

    Altered sense of the body, including floating, detachment, or out-of-body experiences. The 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. Questions 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.

  • Impaired Cognition & Control (11D ASC)Immediately after experimental session

    Difficulty thinking clearly, controlling thoughts, or performing tasks. The 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. Questions 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.

  • Anxiety (11D-ASC)Immediately after experimental session

    Fear, unease, or paranoid thoughts during the experience. The 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. Questions 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.

  • Complex Imagery (11D-ASC)Immediately after experimental session

    Vivid, detailed visual imagery of objects, scenes, or entities. The 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. Questions 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.

  • Elementary Imagery (11D-ASC)Immediately after experimental session

    Simple visual patterns such as colors, shapes, or geometric forms. The 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. Questions 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.

  • Audio-Visual Synesthesia (11D-ASC)Immediately after experimental session

    Cross-modal experiences, such as hearing colors or seeing sounds. The 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. Questions 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.

  • Changed Meaning of Percepts (11D-ASC)Immediately after experimental session

    Altered interpretation of ordinary sensory stimuli, often with symbolic or novel significance. The 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. Questions 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).