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NCT05128162 · ClinicalTrials.gov registry record · Phase 2
Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia
A Phase 2 study, sponsored by Kevin Boehnke.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT05128162: Completed Phase 2 study, sponsored by Kevin Boehnke.
NCT05128162 is a Phase 2 study that has completed, run by Kevin Boehnke. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05128162, a Phase 2 study, has completed, sponsored by Kevin Boehnke.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
The pressing need for effective fibromyalgia (FM) treatments, the known safety of psilocybin therapy, and the mechanistic plausibility for potential benefit provide a backdrop for investigating psilocybin therapy as a treatment for FM. The primary objective of this study is to evaluate the clinical benefit of oral psilocybin in concert with psychotherapy to treat chronic pain symptoms in patients with FM.
Primary Outcome
BPM was measured before TRP-8802 capsule administration and at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration.
Interventions
- BEHAVIORAL Psychotherapy
- DRUG Psilocybin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2023-09-27 |
| Est. Completion | 2024-06-12 |
| Phase | Phase 2 |
What the finished NCT05128162 record still lists
NCT05128162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Psychotherapy is the first listed.
NCT05128162 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05128162 about?
NCT05128162 is a clinical study titled "Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia". The pressing need for effective fibromyalgia (FM) treatments, the known safety of psilocybin therapy, and the mechanistic plausibility for potential benefit provide a backdrop for investigating psilocybin therapy as a treatment for FM. The primary objective of this study is to evaluate the clinical ...
What is the current status of trial NCT05128162?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2023-09-27. Estimated completion is 2024-06-12.
What interventions are being tested in trial NCT05128162?
The interventions under investigation include: Psychotherapy (BEHAVIORAL), Psilocybin (DRUG).
Who is sponsoring clinical trial NCT05128162?
This trial is sponsored by Kevin Boehnke, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05128162's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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