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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07296328
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Stuttering

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    Participants will receive a single oral high-dose of psilocybin, 25 mg.
  • Speech therapy — BEHAVIORAL
    Speech therapy will consist of standard stuttering modification therapy, which includes four phases: Identification, Desensitization, Modification, Stabilization.

Study Details

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.

Key Dates

Start date
Jan 15, 2026
Status verified
Dec 2025
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adult stutterers
    Participation will occur over an 8-week, 10-session period. Six sessions speech therapy; one preparatory therapy session prior to the drug administration session; one 8-hour drug administration session (25 mg of psilocybin); two follow-up therapy sessions following the drug administration session.

Primary Outcome Measure

Change in Stuttering Severity Instrument - 4th Edition (SSI-4) total score [ Time Frame: Week 4, Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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