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NCT07306364 · ClinicalTrials.gov registry record · Phase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
A Phase 2 study, sponsored by Yale University.
- Not yet
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT07306364: Clinical Trial Phase 2 study, sponsored by Yale University.
NCT07306364 is a Phase 2 study that has not yet begun recruiting, run by Yale University. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07306364, a Phase 2 study, has not yet begun recruiting, sponsored by Yale University.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this research study is to investigate whether a single administration of psilocybin can improve interoceptive awareness (awareness of bodily sensations) in individuals with chronic low back pain undergoing physical therapy, and whether these improvements are linked to pain relief and better physical therapy outcomes.
Primary Outcome
The Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) is a validated 37-item, self-report instrument assessing mind-body connections (i.e., interoceptive awareness). MAIA-2 scoring involves rating the 37 items on a 0 (never) to 5 (always) Likert scale, resulting in scores for eight subscales (Noticing, Not-distracting, Not-worrying, Attention regulation, Emotional awareness, Self-regulation, Body Listening, Trusting). Scores for each of the 8 scales are averaged (sum of items div
Interventions
- DRUG Psilocybin 25 mg
- DRUG Psilocybin 10 mg
- DRUG Niacin 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2026-06 |
| Est. Completion | 2029-06 |
| Phase | Phase 2 |
What is known before NCT07306364 opens enrollment
NCT07306364 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 3 interventions - of which Psilocybin 25 mg is the first listed.
NCT07306364 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07306364 about?
NCT07306364 is a clinical study titled "Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain". The purpose of this research study is to investigate whether a single administration of psilocybin can improve interoceptive awareness (awareness of bodily sensations) in individuals with chronic low back pain undergoing physical therapy, and whether these improvements are linked to pain relief and ...
What is the current status of trial NCT07306364?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2026-06. Estimated completion is 2029-06.
What interventions are being tested in trial NCT07306364?
The interventions under investigation include: Psilocybin 25 mg (DRUG), Psilocybin 10 mg (DRUG), Niacin 100 mg (DRUG).
Who is sponsoring clinical trial NCT07306364?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07306364's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 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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