Psilocybin-facilitated Treatment for Chronic Pain
Eligible age
25–65 yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
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About this study
The primary purpose of this study is to preliminarily estimate the efficacy of psilocybin-facilitated treatment for fibromyalgia. Investigators will assess the impact of psilocybin-facilitated treatment on pain, fatigue, and other fibromyalgia symptoms, in addition to the level of functioning and quality of life. Investigators will also evaluate potential mediators of treatment (e.g., treatment expectations, pain characteristics, personality, beliefs/cognitions, emotions). Investigators hypothesize psilocybin treatment will significantly reduce symptom severity in fibromyalgia patients.
Sponsor: University of Alabama at Birmingham
You may qualify if…
- ✓ 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;
You may not qualify if…
- ✕ 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;
Where it's recruiting
Birmingham
Source: ClinicalTrials.gov · NCT05068791 · last updated 2026-03-11