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

NCT07296328 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-12-22

No results posted yet for this 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.

Conditions

  • Stuttering

Interventions

DRUG

Psilocybin

Participants will receive a single oral high-dose of psilocybin, 25 mg.

BEHAVIORAL

Speech therapy

Speech therapy will consist of standard stuttering modification therapy, which includes four phases: Identification, Desensitization, Modification, Stabilization.

Sponsors & Collaborators

Principal Investigators

  • Michael Bogenschutz, MD · NYU Langone Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2027-04-01
Completion
2027-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07296328 on ClinicalTrials.gov