Phase 1: testing Psilocybin (high dose) for Psilocybin
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?
Official registry: https://clinicaltrials.gov/study/NCT07180108 · Johns Hopkins University · enrollment listed as 100
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Psilocybin (high dose), Playlist 1, or Playlist 2. The registry lists allocation as na. 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.
They plan to enroll about 100 people at Baltimore. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
PRoMiSS: Psilocybin and the Role of Music in Set and Setting
Interventions: Psilocybin (high dose), Playlist 1, Playlist 2, Playlist 3, Playlist 4, Playlist 5
Primary outcome (registry wording): Challenging Experiences Questionnaire
Who it is for (from inclusion criteria)
- Ages 21 Years to 75 Years
- No hearing impairment
- Have a screening weight ≥ 40 kg (88.18 lbs) with body-mass index (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 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)
Who the registry excludes
- 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
- Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
- 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
Public study contact (from the registry)
David S Rosen, PhD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Center for Psychedelics and Consciousness Research in the Behavioral Biology Research Center — Baltimore, Maryland (recruiting)
FAQ about this NCT record
Is NCT07180108 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07180108?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07180108?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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