drugset / Trial / NCT07296328

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

NCT07296328 ↗

Phase 2 Not yet recruiting 25 enrolled NYU Langone Health
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-01-15
Primary completion
2027-04-01
Completion
2027-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Psilocybin Other / unclassified 25 mg Oral

Indications