Birmingham, ALNCT05068791Now EnrollingIRB Ready

Fibromyalgia, Primary Clinical Trial in Birmingham, AL

Access cutting-edge fibromyalgia, primary treatment through this early phase 1 clinical trial at a research site in Birmingham. Study-provided care at no cost to qualified participants.

Sponsored by University of Alabama at Birmingham

Quick Self-Assessment

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Expert Care in Birmingham

Access fibromyalgia, primary specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related fibromyalgia, primary treatment provided free

Apply for This Birmingham Location

Check if you qualify for this fibromyalgia, primary clinical trial in Birmingham, AL

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Birmingham

    Convenient for AL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Birmingham site if eligible
  4. 4Begin participation

About This Fibromyalgia, Primary Study in Birmingham

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

Who Can Participate

Inclusion Criteria

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

Exclusion Criteria

ary medication occurring at least two weeks and for at least 5 half-lives, whichever is longer, prior to drug administration day. Exclusion Criteria:
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);
Levels of thyroid-stimulating hormone or free thyroxine outside UAB Hospital Labs reference values;
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;
Severe anemia;
Phenylketonuria, chronic bronchitis, emphysema, asthma, diabetes, liver disease, and mucus with cough or slowed breathing
Use of any medication containing dextromethorphan (e.g., cough suppressants);
Pain due to other conditions or diseases that would complicate study participation or pain reporting.
Use of strong or moderate inhibitors of Cytochrome P450 2D6 (CYP2D6)
Poor metabolizers of CYP2D6 based on genotype

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Birmingham?

Yes, this clinical trial (NCT05068791) has an active research site in Birmingham, AL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Fibromyalgia, Primary Treatment Options in Birmingham, AL

If you're searching for fibromyalgia, primary treatment options in Birmingham, AL, this clinical trial (NCT05068791) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Birmingham research site is actively enrolling participants for this early phase 1 clinical trial. You'll receive care from experienced fibromyalgia, primary specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all fibromyalgia, primary clinical trials near you to find additional studies recruiting in your area.

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