PRoMiSS: Psilocybin and the Role of Music in Set and Setting
Public ClinicalTrials.gov record NCT07180108. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT07180108
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Interventions
- Psilocybin (high dose) Drug
- Playlist 1 Behavioral
- Playlist 2 Behavioral
- Playlist 3 Behavioral
- Playlist 4 Behavioral
- Playlist 5 Behavioral
Drug · Behavioral
Eligibility (public fields only)
- Age range
- 21 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 11, 2025
- Primary completion
- May 31, 2028
- Completion
- Jul 31, 2028
- Last update posted
- Sep 17, 2025
2025 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Center for Psychedelics and Consciousness Research in the Behavioral Biology Research Center | Baltimore | Maryland | 21224 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07180108, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 17, 2025 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07180108 live on ClinicalTrials.gov.