NCT05068791 Psilocybin-facilitated Treatment for Chronic Pain
| NCT ID | NCT05068791 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Alabama at Birmingham |
| Condition | Fibromyalgia, Primary |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2023-11-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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); 18. Diagnosed rheumatologic or auto-immune condition; 19. Blood or clotting disorder; 20. Current hypertension (exceeding 140 systolic or 90 diastolic at resting); resting heart rate\>90 21. Acute infection (oral temperature \>100°F); 22. High-sensitivity c-reactive protein (hs-CRP) ≥ 10mg/L; 23. Erythrocyte sedimentation rate (ESR) \> 60 mm/hr; 24. Positive rheumatoid factor; 25. Positive anti-nuclear antibody (ANA); 26. Levels of thyroid-stimulating hormone or free thyroxine outside UAB Hospital Labs reference values; 27. Use of UGT1A9, UGT1A10 and aldehyde or alcohol dehydrogenase enzyme inhibitors; 28. Dependent on any psychoactive drugs other than nicotine and caffeine; 29. Use of the antiviral drug efavirenz; 30. Use of PDE-5-Inhibitors, soluble guanylate cyclase (sGC) stimulators; 31. Severe anemia; 32. Phenylketonuria, chronic bronchitis, emphysema, asthma, diabetes, liver disease, and mucus with cough or slowed breathing 33. Use of any medication containing dextromethorphan (e.g., cough suppressants); 34. Pain due to other conditions or diseases that would complicate study participation or pain reporting. 35. Use of strong or moderate inhibitors of Cytochrome P450 2D6 (CYP2D6) 36. Poor metabolizers of CYP2D6 based on genotype
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05068791 clinical trial?
This trial is open to female participants only, aged 25 Years or older, up to 65 Years, studying Fibromyalgia, Primary. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05068791 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05068791 currently recruiting?
Yes, NCT05068791 is actively recruiting participants. Contact the research team at phendricks@uab.edu for enrollment information.
Where is the NCT05068791 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT05068791 clinical trial?
NCT05068791 is sponsored by University of Alabama at Birmingham. The trial plans to enroll 30 participants.
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