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NCT07296328 · ClinicalTrials.gov registry record · Phase 2
Effects of Psilocybin on Speech Fluency, Struggle, and Brain Activity in People Who Stutter
A Phase 2 study, sponsored by NYU Langone Health.
- Not yet
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT07296328: Clinical Trial Phase 2 study, sponsored by NYU Langone Health.
NCT07296328 is a Phase 2 study that has not yet begun recruiting, run by NYU Langone Health. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07296328, a Phase 2 study, has not yet begun recruiting, sponsored by NYU Langone Health.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
This Phase 2a clinical trial is an open-label, single-group, within-subjects pilot study designed to evaluate the safety, feasibility, and preliminary efficacy of psilocybin as a therapeutic intervention for adults with developmental stuttering. This pilot study will assess whether further research to explore the potential benefits of psilocybin-assisted therapy for improving clinical outcomes in individuals who stutter, is warranted. The aims of this study include: * Aim 1: Assess the safety and feasibility of psilocybin as a therapeutic agent for stuttering. * Aim 2: Evaluate the effects of psilocybin on objective and subjective measures of stuttering severity, struggle, and well-being. * Aim 3: Explore the therapeutic neural mechanisms of psilocybin in stuttering.
Primary Outcome
The Stuttering Severity Instrument-4th Edition (SSI-4) provides a total score that is compared to age-specific norms to determine severity, with ranges for "Very Mild" to "Very Severe". The SSI-4 calculates individual scores for frequency (2-18), duration (2-18), and physical concomitants (0-20). These individual scores are combined to create a total score, which is then ranked against norms to provide a verbal severity descriptor, such as mild, moderate, severe, or very severe.
Interventions
- DRUG Psilocybin
- BEHAVIORAL Speech therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2026-01-15 |
| Est. Completion | 2027-04-01 |
| Phase | Phase 2 |
What is known before NCT07296328 opens enrollment
NCT07296328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Psilocybin is the first listed.
NCT07296328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07296328 about?
NCT07296328 is a clinical study titled "Effects of Psilocybin on Speech Fluency, Struggle, and Brain Activity in People Who Stutter". This Phase 2a clinical trial is an open-label, single-group, within-subjects pilot study designed to evaluate the safety, feasibility, and preliminary efficacy of psilocybin as a therapeutic intervention for adults with developmental stuttering. This pilot study will assess whether further research ...
What is the current status of trial NCT07296328?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2026-01-15. Estimated completion is 2027-04-01.
What interventions are being tested in trial NCT07296328?
The interventions under investigation include: Psilocybin (DRUG), Speech therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT07296328?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07296328's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 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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