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NCT05068791 · ClinicalTrials.gov registry record · Early Phase 1
Psilocybin-facilitated Treatment for Chronic Pain
A Early Phase 1 study of Fibromyalgia, Primary, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05068791: Recruiting Early Phase 1 study of Fibromyalgia, Primary, sponsored by University of Alabama at Birmingham.
NCT05068791 is a Early Phase 1 study of Fibromyalgia, Primary that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 30 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05068791, a Early Phase 1 study of Fibromyalgia, Primary, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Daily pain severity will be measured using a visual analog scale rated from 0 ('no pain at all') to 100 ('severe pain')
Conditions Studied
Interventions
- DRUG Psilocybin
- DRUG Dextromethorphan
Study Locations (1)
Alabama
- UAB Beacon Tower - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2026-12-31 |
| Phase | Early Phase 1 |
What NCT05068791 shows while recruiting
NCT05068791 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower).
The record links to 1 condition, with Fibromyalgia, Primary appearing as the primary indexed condition, and to 2 interventions - of which Psilocybin is the first listed.
NCT05068791 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT05068791 about?
NCT05068791 is a clinical study titled "Psilocybin-facilitated Treatment for Chronic Pain". 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 qu...
What is the current status of trial NCT05068791?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2023-11-01. Estimated completion is 2026-12-31.
What conditions does trial NCT05068791 study?
This clinical trial studies the following conditions: Fibromyalgia, Primary.
What interventions are being tested in trial NCT05068791?
The interventions under investigation include: Psilocybin (DRUG), Dextromethorphan (DRUG).
Who is sponsoring clinical trial NCT05068791?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05068791 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fibromyalgia, Primary
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05068791's enrollment target sits among peer trials
30 807th of 2000 higher than 1,075 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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