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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07180108
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

  • Music Intervention
  • Psilocybin

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Psilocybin (high dose) — DRUG
    25 mg pill
  • Playlist 1 — BEHAVIORAL
    Six hour playlist
  • Playlist 2 — BEHAVIORAL
    A six hour playlist
  • Playlist 3 — BEHAVIORAL
    A six hour playlist
  • Playlist 4 — BEHAVIORAL
    A six hour playlist
  • Playlist 5 — BEHAVIORAL
    A six hour playlist

Study Details

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

Key Dates

Start date
Aug 12, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 6 hour playlist of music
    A 6 hour playlist of music.

Primary Outcome Measure

Challenging Experiences Questionnaire [ Time Frame: Immediately at the end of their experimental session ]

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Psychedelics and Consciousness Research in the Behavioral Biology Research CenterBaltimoreMaryland21224-

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By research site
Center for Psychedelics and Consciousness Research in the Behavioral Biology Research Center· Baltimore, MD

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