Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia

Exclusion Criteria

• •Participants are excluded from the study if any of the following criteria apply:
• •Medical Conditions
• •Participant has had (within the past 1 year) a cardiovascular condition such as coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged QTc interval (i.e., QTc \> 450 msec), artificial heart valve, or transient ischemic attack.
• •Participant has epilepsy with a history of seizures.
• •Participant has insulin-dependent diabetes.
• •Participant is taking an oral hypoglycemic agent and has a history of hypoglycemia.
• •Participant has active auto-immune disease (e.g., lupus, rheumatoid arthritis).
• •Participant has a current or past history of meeting Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or bipolar I or II disorder measured via SCID-5 and SCID-5-PD.
• •Participant has a current or past history (within 1 year) of meeting DSM-5 criteria for a moderate or severe alcohol, tobacco, or other drug use disorder (excluding caffeine) measured via relevant questions from the SCID-5.
• •Participant has a history of a medically significant suicide attempt.
• •Prior/Concomitant Therapy
• •Participant is taking psychoactive prescription medication (e.g., opioids, tramadol, benzodiazepines) on a regular basis (i.e., more than 2 times a week).
• •Participant is currently taking an antidepressant. Participants will also be required to refrain from using antidepressant medications through the completion of primary outcome assessments. Note: if a participant self-initiates a medication taper with the consent and support of their physician, they can re-screen after the appropriate time period.
• •Participant is currently taking bupropion or antidepressants other than selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs).
• •Participant is currently taking on a regular (e.g., daily) basis any medications having 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.
• •Participant tests above 0.02% blood alcohol content on breath alcohol testing and/or positive for cocaine, methamphetamine, or opioids on urine drug testing.
• •Participant has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
• •Prior/Concurrent Clinical Study Experience
• •\- Participant is currently in another clinical trial.
• •Diagnostic assessments
• •Participant has a significant suicide risk as defined by:
• •1. suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year at Screening or at Baseline; or
• •2. suicidal behaviors within the past year; or
• •3. clinical assessment of significant suicidal risk during participant interviews
• •Participant has severe depression as measured through PHQ-8 at Screening.
• •Other Exclusions
• •Participant is pregnant (as indicated by a positive urine pregnancy test assessed at Screening and before each psilocybin session) or nursing.
• •Participant is a WOCBP and sexually active, or a man and sexually active, and not practicing an effective means of birth control.
• •Participant has a confirmed first- or second-degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or bipolar I or II disorder.