RecruitingEarly Phase 1NCT05068791

Psilocybin-facilitated Treatment for Chronic Pain


Sponsor

University of Alabama at Birmingham

Enrollment

30 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 25 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether psilocybin (a compound found in psychedelic mushrooms) can help reduce widespread chronic pain in women with fibromyalgia — a condition characterized by widespread musculoskeletal pain, fatigue, and sleep problems that is often difficult to treat with standard medications. You may be eligible if: - You are a woman between 25 and 65 years old - You have had widespread musculoskeletal pain for at least 12 months - You meet the diagnostic criteria for fibromyalgia - Your average daily pain is at least 5 out of 10 - You have not used hallucinogens in the past 3 years (or have never used them) - You have a trusted person who can drive you home after drug sessions - You can attend all visits at the study location You may NOT be eligible if: - You are male - You have used opioid medications in the last 60 days - You are taking antidepressants (SSRIs, MAOIs, tricyclics), antipsychotics, lithium, or St. John's Wort - You have a personal or family history of psychotic disorders or bipolar disorder - You have uncontrolled high blood pressure, active infections, or autoimmune conditions - You are pregnant or planning to become pregnant within 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin

0.36 mg/kg will be administered orally to participants

DRUGDextromethorphan

2.6 mg/kg of active placebo will be administered orally to participants


Locations(1)

UAB Beacon Tower

Birmingham, Alabama, United States

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NCT05068791


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