Actively Recruiting

Early Phase 1
Age: 25Years - 65Years
FEMALE
NCT05068791

Psilocybin-facilitated Treatment for Chronic Pain

Led by University of Alabama at Birmingham · Updated on 2026-03-11

30

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Psilocybin-facilitated Treatment for Chronic Pain

Who Can Participate

Age: 25Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female age 25-65
  • Widespread musculoskeletal pain for 12 months or more
  • Symptoms meet the American College of Rheumatology 2016 fibromyalgia diagnostic criteria
  • Participant completes daily symptom reports with at least 80% completion during baseline
  • Able to attend all scheduled UAB appointments
  • Ability to read and write in English
  • No hallucinogen use in the past 3 years or never used hallucinogens
  • Availability of a friend or family member to care for and drive participant home after drug administration
  • Current average daily pain score of at least 5 on a 0-10 scale
  • Discontinuation of exclusionary medications at least two weeks and for at least 5 half-lives prior to drug administration day
Not Eligible

You will not qualify if you...

  • Male gender
  • Use of opioid medications in the last 60 days
  • Regular use of anti-inflammatory medications such as aspirin, ibuprofen, or naproxen
  • Use of blood thinning medications
  • Use of tricyclic antidepressants, lithium, SSRIs, MAOIs, St. John's Wort, 5-HT, haloperidol, antipsychotics, mood stabilizers, or medications with serotonin activity
  • Daily consumption of grapefruit juice
  • Febrile illness or antibiotic use in the 4 weeks before study start
  • Planned surgery or procedures during study or surgery within 4 weeks before study
  • Planning to move from Birmingham area within 6 months
  • Planned vaccination during study or vaccination within 4 weeks before study
  • Current participation in another treatment trial
  • Pregnant, planning pregnancy within 6 months, or breastfeeding
  • Significant untreated or unstable psychiatric conditions or high depression scores
  • Current or past psychotic disorders or bipolar I/II disorder
  • First or second-degree relatives with psychotic or bipolar disorders
  • Current suicidal or homicidal thoughts
  • Diagnosed rheumatologic or autoimmune conditions
  • Blood or clotting disorders
  • Current hypertension exceeding 140/90 or resting heart rate over 90
  • Acute infection with temperature over 100°F
  • High-sensitivity C-reactive protein 10 mg/L or above
  • Erythrocyte sedimentation rate over 60 mm/hr
  • Positive rheumatoid factor or anti-nuclear antibody
  • Abnormal thyroid hormone levels
  • Use of certain enzyme inhibitors
  • Dependence on psychoactive drugs other than nicotine or caffeine
  • Use of antiviral drug efavirenz
  • Use of PDE-5 inhibitors or soluble guanylate cyclase stimulators
  • Severe anemia
  • Phenylketonuria, chronic bronchitis, emphysema, asthma, diabetes, liver disease, or mucus with cough or slowed breathing
  • Use of any medication containing dextromethorphan
  • Pain due to other conditions complicating participation or reporting
  • Use of strong or moderate CYP2D6 inhibitors
  • Poor metabolizers of CYP2D6 enzyme based on genotype

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

UAB Beacon Tower

Birmingham, Alabama, United States, 35209

Actively Recruiting

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Research Team

P

Peter Hendricks, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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