Psilocybin-assisted treatment for people living with fibromyalgia

Who can take part

• Female age 25-65
• Widespread musculoskeletal pain for ≥12 months
• Symptoms meeting the American College of Rheumatology (ACR) 2016 revisions to the 2010/2011 Fibromyalgia Diagnostic Criteria
• Participant completes daily report during baseline period (at least 80% completion rate)
• Able to attend UAB for all scheduled appointments
• Ability to read/write in English
• No prior hallucinogen use or it will have been at least 3 years since last use of a hallucinogen
• 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
• A current average daily pain score of at least 5 on a 0-10 scale
• Discontinuation of exclusionary medication occurring at least two weeks and for at least 5 half-lives, whichever is longer, prior to drug administration day

Who cannot take part

• Use of opioid medications in the last 60 days
• Regular use of any anti-inflammatory medication (e.g., aspirin, ibuprofen, naproxen)
• Use of blood thinning medication
• 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
• Febrile illness or use of antibiotics in the 4 weeks before study commencement
• Planned surgery or procedures during the study period, or operated on in the 4 weeks prior to study commencement
• Planned vaccination during the study period, or vaccinated in the 4 weeks before study commencement
• Positive anti-nuclear antibody (ANA)
• Use of UGT1A9, UGT1A10 and aldehyde or alcohol dehydrogenase enzyme inhibitors
• Dependent on any psychoactive drugs other than nicotine and caffeine
• Use of the antiviral drug efavirenz
• Use of PDE-5-Inhibitors, soluble guanylate cyclase (sGC) stimulators
• Use of any medication containing dextromethorphan (e.g., cough suppressants)
• Use of strong or moderate inhibitors of Cytochrome P450 2D6 (CYP2D6)
• 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
• Current or past history of any psychotic disorders
• Current or past history of bipolar I or II disorder
• First or second-degree relatives with any psychotic disorders, or bipolar I or II disorders
• Diagnosed rheumatologic or auto-immune condition
• Blood or clotting disorder
• Current hypertension (exceeding 140 systolic or 90 diastolic at resting); resting heart rate>90
• Acute infection (oral temperature >100°F)
• Phenylketonuria, chronic bronchitis, emphysema, asthma, diabetes, liver disease, and mucus with cough or slowed breathing
• Pain due to other conditions or diseases that would complicate study participation or pain reporting
• Males
• Daily consumption of grapefruit juice
• Planning to move from the Birmingham area in the next 6 months
• Current participation in another treatment trial
• Pregnant or planning to become pregnant within 6 months, or currently breastfeeding
• Current suicidal or homicidal ideation (assessed using Columbia-Suicide Severity Rating Scale at each visit)
• High-sensitivity c-reactive protein (hs-CRP) ≥ 10mg/L
• Erythrocyte sedimentation rate (ESR) > 60 mm/hr
• Positive rheumatoid factor
• Levels of thyroid-stimulating hormone or free thyroxine outside UAB Hospital Labs reference values
• Severe anemia
• Poor metabolizers of CYP2D6 based on genotype