Psilocybin-facilitated Treatment for Chronic Pain

Inclusion Criteria: 1. Female age 25-65; 2. Widespread musculoskeletal pain for ≥12 months; 3. Symptoms meeting the American College of Rheumatology (ACR) 2016 revisions to the 2010/2011 Fibromyalgia Diagnostic Criteria; 4. Participant completes daily report during baseline period (at least 80% completion rate); 5. Able to attend UAB for all scheduled appointments; 6. Ability to read/write in English; 7. No prior hallucinogen use or it will have been at least 3 years since last use of a hallucinogen; 8. Availability of a friend or family member into whose care the participant can be released (a key responsibility includes driving participants home) following their drug administration session; 9. A current average daily pain score of at least 5 on a 0-10 scale; 10. Discontinuation of exclusionary medication occurring at least two weeks and for at least 5 half-lives, whichever is longer, prior to drug administration day. Exclusion Criteria: 1. Males; 2. Use of opioid medications in the last 60 days; 3. Regular use of any anti-inflammatory medication (e.g., aspirin, ibuprofen, naproxen); 4. Use of blood thinning medication; 5. Use of tricyclic antidepressants, lithium, SSRIs, MAOIs, St. John's Wort, 5-hydroxytryptophan (5-HT), haloperidol, or other antipsychotic medications, mood stabilizers, or medications with serotonin activity; 6. Daily consumption of grapefruit juice; 7. Febrile illness or use of antibiotics in the 4 weeks before study commencement; 8. Planned surgery or procedures during the study period, or operated on in the 4 weeks prior to study commencement; 9. Planning to move from the Birmingham area in the next 6 months; 10. Planned vaccination during the study period, or vaccinated in the 4 weeks before study commencement; 11. Current participation in another treatment trial; 12. Pregnant or planning to become pregnant within 6 months, or currently breastfeeding; 13. Significant psychological comorbidity that in the discretion of the investigator compromises study integrity (i.e., presence of a current, clinically significant, untreated or unstable psychiatric condition) and/or a baseline HADS depression subscale score of ≥16; 14. Current or past history of any psychotic disorders; 15. Current or past history of bipolar I or II disorder; 16. First or second-degree relatives with any psychotic disorders, or bipolar I or II disorders; 17. Current suicidal or homicidal ideation (assessed using Columbia-Suicide Severity Rating Scale at each visit);…