Effects of Psilocybin on Speech Fluency, Struggle, and Brain Activity in People Who Stutter
NYU Langone Health
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.
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Are able to provide voluntary informed consent * Are able to read, speak, and understand English, as documented during the informed consent process. 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 a…
Interventions
- DrugPsilocybin
Participants will receive a single oral high-dose of psilocybin, 25 mg.
- BehavioralSpeech therapy
Speech therapy will consist of standard stuttering modification therapy, which includes four phases: Identification, Desensitization, Modification, Stabilization.
Location
- NYU Langone HealthNew York, New York