Psilocybin-facilitated Treatment for Chronic Pain

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: Fibromyalgia, Primary

In brief

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.

Key facts

Study ID

NCT05068791

Run by

University of Alabama at Birmingham

People needed

30

Starts

2023-11-01

Expected to finish

2026-12-31

Last updated by the study team

2026-03-11

Who can join

Age: 25 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Males;
• 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;
• Daily consumption of grapefruit juice;
• 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;
• Planning to move from the Birmingham area in the next 6 months;
• Planned vaccination during the study period, or vaccinated in the 4 weeks before study commencement;
• Current participation in another treatment trial;
• Pregnant or planning to become pregnant within 6 months, or currently breastfeeding;
• 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;
• Current suicidal or homicidal ideation (assessed using Columbia-Suicide Severity Rating Scale at each visit);
• 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);
• High-sensitivity c-reactive protein (hs-CRP) ≥ 10mg/L;
• Erythrocyte sedimentation rate (ESR) > 60 mm/hr;
• Positive rheumatoid factor;
• Positive anti-nuclear antibody (ANA);

Where it is running

• UAB Beacon Tower — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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