Psilocybin for Music Therapy

(PRoMiSS Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Johns Hopkins University

Must not be taking: Psychoactive, MAOIs

Disqualifiers: Cardiovascular conditions, Diabetes, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how personal music affects emotions and well-being when combined with psilocybin, a compound in psychedelic mushrooms. Researchers compare different music playlists to determine which enhances mood and emotional responses most effectively during a psilocybin session. Healthy adults who enjoy music and have limited past use of hallucinogens may be suitable candidates. Participants will take psilocybin, listen to music, and undergo various brain and body monitoring procedures. The goal is to understand how personalized music might enhance the positive effects of psilocybin. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to experience this innovative approach firsthand.

Do I have to stop taking my current medications for the trial?

You may need to stop taking some medications before participating in the trial. Specifically, you must refrain from using any psychoactive drugs within 24 hours of each drug session and avoid certain medications like sildenafil (Viagra) within 72 hours. If you are taking psychoactive prescription medications regularly, you may need to stop them, but exceptions can be made for medications with a short half-life if you can abstain on session days.

Is there any evidence suggesting that psilocybin is likely to be safe for humans?

A previous study found no serious side effects with a single dose of psilocybin, suggesting safety for immediate mental and physical effects. Another study noted possible side effects, including increased blood pressure, headaches, nausea, vomiting, tiredness, and anxiety, but these were not severe. Therapists have found psilocybin-assisted treatments to be safe and meaningful when used properly. While some mild side effects might occur, research supports the overall safety of psilocybin for trials like this one. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Psilocybin is unique because it combines a psychedelic compound with music therapy, potentially offering a new way to enhance the therapeutic experience. Unlike standard treatments that might focus solely on medication or therapy, this approach uses psilocybin to potentially alter brain activity and create a more receptive state for music therapy. Researchers are excited because this combination could lead to deeper emotional breakthroughs and improvements in mental health conditions, offering a novel pathway that differs from traditional methods like antidepressants or cognitive behavioral therapy.

What evidence suggests that this trial's treatments could be effective?

Research shows that psilocybin can enhance emotional and mental responses to music. Studies have found that individuals undergoing psilocybin therapy feel more connected to music, experiencing stronger emotions and changes in brain activity. Evidence also suggests that psilocybin can elevate mood and improve well-being, with participants reporting increased empathy and improved relationships. Although effects can vary among individuals, these findings support the idea that combining psilocybin with music might lead to meaningful emotional experiences and mental health benefits. ^{2 6 7 8 9}

Who Is on the Research Team?

Frederick S Barrett, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 21 to 75 interested in how different types of music affect the experience and benefits of psilocybin. Participants must be willing to take a high dose of psilocybin, undergo brain scans, and attend several follow-up sessions. Specific eligibility criteria are not provided.

Inclusion Criteria

Fluent in English

No hearing impairment

Right-handed

Exclusion Criteria

Unusually low reward response to music (majority of responses of '1' on the BMRQ)

Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders, or Bipolar I Disorder

Current or history within one year of meeting DSM-5 criteria for a moderate or severe substance use disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take a single oral dose of psilocybin (25 mg) during one study session and listen to one of the five music conditions while undergoing EEG and physiological monitoring.

1 day

1 visit (in-person)

Follow-up

Participants return for follow-ups to assess short-term and longer-term outcomes, including well-being, mood, and meaning-making.

1 month

3 visits (in-person) at 1 day, 1 week, and 1 month

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview Researchers are testing if personal, meaningful music enhances emotional responses and well-being when combined with a high dose of psilocybin compared to standardized or ambient playlists. They're studying brain and body reactions through EEGs, heart rate monitoring, and other measures during the session.

How Is the Trial Designed?

Group I: 6 hour playlist of music Experimental Treatment 6 Interventions

A 6 hour playlist of music.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Steven & Alexandra Cohen Foundation

Collaborator

Trials

10

Recruited

320+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5893695/

The hidden therapist: evidence for a central role of music in ... The present study assessed the influence of music on the acute experience and clinical outcomes of psychedelic therapy.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032723005426

Increased low-frequency brain responses to music after ... These data suggest an effect of PT on the brain's response to music, implying an elevated responsiveness to music after psilocybin therapy.

3. nature.com nature.com/articles/s41598-024-53188-9

Patient perspectives and experiences with psilocybin ... Psilocybin treatment for major depressive disorder (MDD) and TRD has recently been awarded 'breakthrough therapy' status by the FDA. With over ...

4. akjournals.com akjournals.com/view/journals/2054/aop/article-10.1556-2054.2025.00461/article-10.1556-2054.2025.00461.xml

Five-year outcomes of psilocybin-assisted therapy for ... Participants reported enhanced empathy, self-acceptance, and improved interpersonal relationships. No severe adverse events were reported.

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2023.1156852/full

A case-study evaluation of the “Copenhagen Music ... We test their music program with an experienced Indigenous therapist/psychonaut on a 3.5 gram psilocybin journey.

6. sciencedirect.com sciencedirect.com/science/article/pii/S277240852400125X

Safety pharmacology of acute psilocybin administration in ... No serious adverse reactions occurred. These findings suggest that a single administration of psilocybin is safe with regard to acute psychological and physical ...

7. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2022.873455/full

Music programming for psilocybin-assisted therapy The use of music to support the acute psychoactive effects of psilocybin is recommended in current guidelines, but descriptions of how to ...

8. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/00048674241289024

The safety of psilocybin-assisted psychotherapy The most common adverse events during and after sessions included elevated blood pressure, headaches, nausea, vomiting, fatigue and anxiety. In ...

9. akjournals.com akjournals.com/view/journals/2054/8/2/article-p196.xml

Journal of Psychedelic Studies Volume 8 Issue 2 (2024) Therapists generally reported psilocybin-assisted treatments to be effective, safe, and meaningful when properly administered. However, the ...