Effects of Psilocybin on Speech Fluency, Struggle, and Brain Activity in People Who Stutter
ConditionStuttering
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-50
SponsorNYU Langone Health
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Are able to provide voluntary informed consent
Are able to read, speak, and understand English, as documented during the informed consent process.
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.
Disqualifiers
Pregnancy or lactation.
Seizure disorder
Significantly impaired liver function, defined as 1) alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 5 × upper limit of normal (ULN); 2) ALT or AST > 3 × ULN with concomitant total bilirubin > 2.0 × ULN; or 3) ALT or AST ≥ 3 × ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia.
Cardiovascular disease including coronary artery disease, angina, history of arrhythmia (unless a successful ablation has been performed), heart failure, history of heart valve replacement, and history of cerebrovascular accident or transient ischemic attack.
Trial design
Design model
Single group
Treatments tested in this trial
Psilocybin
DrugParticipants will receive a single oral high-dose of psilocybin, 25 mg.
Speech therapy
BehavioralSpeech therapy will consist of standard stuttering modification therapy, which includes four phases: Identification, Desensitization, Modification, Stabilization.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Adult stutterersExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Stuttering Severity Instrument - 4th Edition (SSI-4) total score
The Stuttering Severity Instrument-4th Edition (SSI-4) provides a total score that is compared to age-specific norms to determine severity, with ranges for "Very Mild" to "Very Severe". The SSI-4 calculates individual scores for frequency (2-18), duration (2-18), and physical concomitants (0-20). These individual scores are combined to create a total score, which is then ranked against norms to provide a verbal severity descriptor, such as mild, moderate, severe, or very severe.
Time frame
Week 4, Week 122
Change in frequency subcomponent score of the SSI-4
The Stuttering Severity Instrument-4th Edition (SSI-4) provides a total score that is compared to age-specific norms to determine severity, with ranges for "Very Mild" to "Very Severe". The SSI-4 calculates individual scores for frequency (2-18), duration (2-18), and physical concomitants (0-20). These individual scores are combined to create a total score, which is then ranked against norms to provide a verbal severity descriptor, such as mild, moderate, severe, or very severe.
Time frame
Week 4, Week 123
Change in duration subcomponent score of the SSI-4
The Stuttering Severity Instrument-4th Edition (SSI-4) provides a total score that is compared to age-specific norms to determine severity, with ranges for "Very Mild" to "Very Severe". The SSI-4 calculates individual scores for frequency (2-18), duration (2-18), and physical concomitants (0-20). These individual scores are combined to create a total score, which is then ranked against norms to provide a verbal severity descriptor, such as mild, moderate, severe, or very severe.
Time frame
Week 4, Week 124
Change in physical concomitants subcomponent score of the SSI-4
The Stuttering Severity Instrument-4th Edition (SSI-4) provides a total score that is compared to age-specific norms to determine severity, with ranges for "Very Mild" to "Very Severe". The SSI-4 calculates individual scores for frequency (2-18), duration (2-18), and physical concomitants (0-20). These individual scores are combined to create a total score, which is then ranked against norms to provide a verbal severity descriptor, such as mild, moderate, severe, or very severe.
Time frame
Week 4, Week 12Secondary outcomes
1
Change in self-reported stuttering severity Wright and Ayre Stuttering Self-Rating Profile (WASSP) score
The WASSP produces a profile of scores across five subscales. There is a total of 26 items each scored on a seven-point Likert-type scale. A score of '1' represents the least severe/negative perception, while a '7' represents the most severe/negative perception on each scale. Total scores range from 26-182, with higher scores indicating a greater negative impact of stuttering on their life.
Time frame
Week 4, Week 122
Change in the Brief Version of the Unhelpful Thoughts and Beliefs About Stuttering Scales (UTBAS-6) total score
The UTBAS-6 is a six-item screening questionnaire for adults who stutter to measure unhelpful thoughts and beliefs associated with speech anxiety. The UTBAS-6 has a subscale score range of 6 to 30 and a total score range of 18 to 90. A higher score indicates more frequent unhelpful thoughts and greater anxiety related to stuttering.
Time frame
Week 4, Week 123
Change in Brief Fear of Negative Evaluation Scale (BFNE-S) total score
The BFNE-S consists of 8 items that are rated on a five-point likert scale from 1 (not at all characteristic) to 4 (extremely characteristic). Scores range from 0 to 32. A score of 25 or higher may indicate clinically significant social anxiety.
Time frame
Week 4, Week 124
Change in the Social Interaction Anxiety Scale (SIAS) score
The SIAS is a 20-item self-report questionnaire that measures the severity of social anxiety. Each item is rated from 0 (not at all characteristic or true of me) to 4 (extremely characteristic or ture of me). Scores can range from 0 (no social anxiety) to 80 (maximum social anxiety). A score of 36 or higher is often considered clinically significant, suggesting the presence of social anxiety.
Time frame
Week 4, Week 12Sponsors and contacts
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Source ClinicalTrials.gov
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