Recruiting
Phase 1

Psilocybin with Music

Sponsor:

Johns Hopkins University

Code:

NCT07180108

Conditions

Psilocybin

Music Intervention

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Psilocybin (high dose)

Playlist 1

Playlist 2

Playlist 3

Playlist 4

Study Details

Brief summary:

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:

Does 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?

How are brain and body responses - including EEG activity, respiration, heart rate, and skin conductance - influenced by autobiographically salient music under psilocybin?

Do brain and body responses to specific music features differ when the music is autobiographically salient compared to non-salient playlists?

Researchers 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.

Participants will:

  • Take a single oral dose of psilocybin (25 mg) during one study session
  • Listen to one of the five music conditions while reclining in a comfortable setting
  • Complete questionnaires about emotions, acute, subjective effects, insight, etc.
  • Undergo EEG and physiological monitoring (respiration, heart rate, skin conductance) during the session
  • Complete MRI brain scans before the session and 1 week after psilocybin
  • Return for follow-ups at 1 day, 1 week, and 1 month after psilocybin
  • 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

Conditions

Psilocybin

Music Intervention

Study ID

NCT07180108

Start date

Aug 12, 2025

Status verified date

Sep, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • • 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 Criteria:

  • • 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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 6 hour playlist of music

A 6 hour playlist of music.

Interventions

Psilocybin (high dose)

25 mg pill

Playlist 1

Six hour playlist

Playlist 2

A six hour playlist

Playlist 3

A six hour playlist

Playlist 4

A six hour playlist

Playlist 5

A six hour playlist

Primary outcome measure

  • Challenging Experiences Questionnaire [ Time Frame: Immediately at the end of their experimental session ]
  • Psychological Insight Questionnaire (PIQ) [ Time Frame: Immediately at end of experimental session ]
  • Core Flow State Scale (C-FSS) [ Time Frame: Immediately at end of experimental session ]
  • Mystical Experiences Questionnaire (MEQ-30) [ Time Frame: Immediately at end of experimental session ]
  • Experience of Unity (11D-ASC) [ Time Frame: Immediately after experimental session ]
  • Change in EEG oscillatory power across canonical frequency bands (µV²/Hz) [ Time Frame: During experimental session up to 10 hours ]
  • Music Ratings: Autobiographical Salience [ Time Frame: 1-day following experimental session and immediately post 1-month EEG music listening session ]
  • Spiritual Experience - Altered States of Consciousness (ASC-11D) [ Time Frame: Immediately after experimental session ]
  • Blissful State (11D-ASC) [ Time Frame: Immediately after experimental session ]
  • Insightfulness (11D-ASC) [ Time Frame: Immediately after experimental session ]
  • Disembodiment (11D-ASC) [ Time Frame: Immediately after experimental session ]
  • Impaired Cognition & Control (11D ASC) [ Time Frame: Immediately after experimental session ]
  • Anxiety (11D-ASC) [ Time Frame: Immediately after experimental session ]
  • Complex Imagery (11D-ASC) [ Time Frame: Immediately after experimental session ]
  • Elementary Imagery (11D-ASC) [ Time Frame: Immediately after experimental session ]
  • Audio-Visual Synesthesia (11D-ASC) [ Time Frame: Immediately after experimental session ]
  • Changed Meaning of Percepts (11D-ASC) [ Time Frame: Immediately after experimental session ]

Central Contacts and Locations

Central contacts

David S Rosen, PhD

609-502-8900drosen9@jh.edu

Sabina Vitola, M.S.

571-351-9890mvitola1@jh.edu

Locations

Center for Psychedelics and Consciousness Research in the Behavioral Biology Research Center

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Albert Garcia-Romeu, PhD

786-239-7990AGarci33@jhmi.edu

Sandeep Nayak, MD

410-550-0711snayak@jhmi.edu

Principal Investigator:

David Yaden, PhD

More Information

Sponsor

Johns Hopkins University

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Keywords

  • Psilocybin
  • Set and Setting
  • Music Cognition
  • Music-evoked autobiographical memory
  • Emotion
  • Altered State of Consciousness
  • Psychedelics
  • Memory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-09-15.