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

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

Age

• Participant must be 25 to 64 years of age, inclusive, at the time of signing the informed consent form.

Type of Participant and Disease Characteristics

• Participant must meet "criteria for FM per the 2016 FM survey criteria."
• Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least 2 months prior to screening and is expected to remain stable during participation in the study.
• Participant must be a non-smoker (tobacco).
• Participant must be medically stable as determined by screening for medical problems via a personal interview and/or, a medical questionnaire, and an ECG, within 1 month of starting active intervention (performed during screening).
• Participant must agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea, cola) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of psilocybin session days. If the participant does not routinely consume caffeinated beverages, he/she must agree to not do so on psilocybin session days.
• Participant must agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours before and after each psilocybin administration. The exception is caffeine.
• Participant must agree to not take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours before and after each psilocybin administration.
• Participant must agree to not take any pro re nata (PRN) medications on the mornings of psilocybin sessions.
• Participant must agree that for 7 days before each psilocybin session, he/she will refrain from taking any nonprescription medication, cannabis, nutritional supplement, or herbal supplement except when approved by the Principal Investigator. Exceptions will be evaluated by the Principal Investigator and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
• Participant must have at least a high school level of education or equivalent (e.g., General Educational Development [GED] Test).

Sex and Contraceptive/Barrier Requirements

• Contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Females of reproductive potential must agree to use effective birth control for the duration of active intervention (defined as the time from the Baseline [deep phenotyping] visit until the EOT [deep phenotyping] visit).
• Sexually active male participants and/or their female partners must agree to use effective birth control for the duration of active intervention (defined as the time from the Baseline [deep phenotyping] visit until the EOT [deep phenotyping] visit) of the male participant. Male participants must also agree not to donate sperm for the duration of active intervention.

Informed Consent

• Participant has provided informed consent as described in Appendix 1, Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

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).
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