Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Psilocybin for Stuttering

This Phase 2a clinical trial is an open-label, single-group, within-subjects pilot study designed to measure the safety, feasibility, and preliminary how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT07296328 · NYU Langone Health · enrollment listed as 25

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Psilocybin, or Speech therapy. The registry lists allocation as na. This Phase 2a clinical trial is an open-label, single-group, within-subjects pilot study designed to measure the safety, feasibility, and preliminary how well it works of psilocybin as a therapeutic intervention for adults with developmental stuttering.

They plan to enroll about 25 people at New York. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

Effects of Psilocybin on Speech Fluency, Struggle, and Brain Activity in People Who Stutter

Interventions: Psilocybin, Speech therapy

Primary outcome (registry wording): Change in Stuttering Severity Instrument - 4th Edition (SSI-4) total score

Who it is for (from inclusion criteria)

  • Ages 18 Years to 50 Years
  • o Non-English-speaking subjects will be excluded because the study is using only validated English-language versions of assessment instruments
  • Are 18 to 50 years old, inclusive, at Screening visit
  • Have diagnosis of mild-moderate to severe stuttering based on either the SSI-4 or OASES; also confirmed stuttering by stuttering specialist
  • Are able and willing to adhere to all study requirements, including attending all study visits and therapy sessions, and completing all assessments
  • Agree to refrain from taking all non-prescription medications and supplements (nutritional and herbal) for at least 1 week prior to the IP administration session unless approved by the Investigator
  • Can swallow capsules
  • Subjects who are able to become pregnant must comply with the following conditions:

Public study contact (from the registry)

Eric Jackson, PhD

212-992-9470

Ej34@nyu.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07296328 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07296328?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07296328?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary