Psilocybin-facilitated Treatment for Fibromyalgia

This study is exploring if psilocybin, a psychedelic compound, can help reduce pain and other symptoms for women with fibromyalgia. Researchers want to see if psilocybin can improve your pain, fatigue, overall functioning, and quality of life. You would receive either psilocybin (0.36 mg/kg) or an active placebo called dextromethorphan (2.6 mg/kg), which can have similar effects to hallucinogens. The main goal is to measure changes in your daily self-reported pain severity over about 13 weeks. To join, you must be a woman between 25 and 65 years old with widespread musculoskeletal pain for at least 12 months, meeting specific fibromyalgia diagnostic criteria. The study is currently unclear on its recruitment status and plans to enroll 30 participants.

Study design
This is an interventional study with 30 participants, randomized into two groups. You would be blinded, meaning you wouldn't know if you received psilocybin or the active placebo until the study ends.
What's involved
You would attend between 7 to 9 study sessions at UAB. You would also need to complete daily reports during a baseline period.
Compensation
Not stated in the trial record.
Follow-up
Your daily self-reported pain severity will be measured through study completion, up to 13 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05068791

Psilocybin-facilitated Treatment for Chronic Pain

Recruiting
EARLY_PHASE1Ages 25–65InterventionalTreatment
University of Alabama at Birmingham
~30 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:PsilocybinDextromethorphan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in daily self-reported pain severity
Measured over through study completion, up to 13 weeks
Fibromyalgia, Primary
1 sites across 1 states
Alabama1

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  • Change in daily self-reported pain severitythrough study completion, up to 13 weeks

    Daily pain severity will be measured using a visual analog scale rated from 0 ('no pain at all') to 100 ('severe pain')