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

Exclusion Criteria

• •• 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
• •* Currently taking psychoactive prescription medication on a regular (e.g., daily) basis - exceptions may be made at the discretion of the study team physician for participants taking medications with short half-life if participants are able to abstain from taking the medication during session days (e.g. methylphenidate taken for attention or hyperactivity)
• •* Currently taking on a regular (e.g., daily) basis any medications that have a primary centrally-acting serotonergic effect, including Monoamine Oxidase Inhibitors (MAOIs). For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.
• •* 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
• •* History of a medically significant suicide attempt as assessed by a study team clinician
• •* Standard MRI contraindications: head trauma, claustrophobia incompatible with scanning, contraindicated medical devices, prior history as a metal worker and/or certain metallic objects in the body -- must complete MRI screening form and be approved by MRI technologist before each scan
• •* History of migraine.
• •* History of angiotensin-converting enzyme inhibitor (ACEi) angioedema