Health TrialsbyHealthPanel

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

ConditionsPsilocybinMusic Intervention
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-75
SponsorJohns Hopkins University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

• Fluent in English

No hearing impairment

Right-handed

Have a screening weight ≥ 40 kg (88.18 lbs) with BMI ≥16.

Disqualifiers

• 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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: 6 hour playlist of musicExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

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. 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.

Time frame
Immediately at the end of their experimental session
2

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. 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.

Time frame
Immediately at end of experimental session
3

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

Time frame
Immediately at end of experimental session
4

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. 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.

Time frame
Immediately at end of experimental session

Secondary outcomes

1

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. We will be measuring a change in BOLD signal between the pre-experiment (preparation 2) and 1-week post-experiment. The main contrasts will include: * Pre vs Post (all music) * Pre vs Post (Autobiographically Salient music) * Pre vs. Post (JHC playlist music) * Pre vs Post (AMB playlist music)

Time frame
At Preparation Session 2 (before experimental session) and 1-week post experimental session
2

Joyful Activation (GEMS-Joy)

Cheerfulness, enthusiasm, vitality, dancing or movement impulses The Geneva Emotional Music Scale (GEMS) is a validated, music-specific instrument designed to measure the range of emotions evoked by music. GEMS is scored from 0 (not at all) to 4 (extremely). A higher Joyful Activation score is generally positive and liked to pleasurable absorption and well-being.

Time frame
1-day after experimental session
3

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. The BIS-11 is scored from 0 (Rarely/Never) to 3 (Almost Always/Always). Generally lower impulsivity is better.

Time frame
Preparation (pre experiment), 1-week post experimental session, and 1-month post experimental session
4

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. The CDFS is measured from 1 (never) to 5 (always). A higher score is generally better.

Time frame
Preparation (pre experiment), 1-week post experimental session, and 1-month post post experimental session

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Steven & Alexandra Cohen Foundation

Collaborator

Source ClinicalTrials.gov
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