Dopamine and Sensorimotor Function in Stuttering

NCT07215884 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 1R21DC021557-01A1R21DC021557
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to understand the effect of aripiprazole on adults who stutter. Stuttering is a disorder that affects speech fluency. This study aims to understand sensorimotor pathways of stuttering and possible interventions.

Conditions

Stuttering, Adult

Keywords

Stuttering; Aripiprazole; Adults with Stuttering; Speech Fluency; Auditory Feedback

Outcome Measures

Primary Outcomes (4)

• Pre-speech auditory modulation

  Pre-speech auditory modulation (PSAM) is a measure of auditory cortical activity (as collect via magnetoencephalography) in response to a speaking and and matching silent reading task.

  3-4 hours after intervention dose is delivered

• Speaking Induced Suppression (SIS)

  SIS is a phenomenon measured through magnetoencephalography that is a marker of auditory cortical response to self-produced speech compared with playback of the same speech.

  3-4 hours after intervention

• Centering

  This is a speech behavior associated with SIS involving a reduction of speech variability from speech onset to mid-utterances. This is derived from auditory recordings occurring during magnetoencephalography collection.

  3-4 hours after intervention

• Feedback alterations

  This is a measure of fluency enhancement by altered speech feedback (manipulated by methods such as masking noise, frequency shifted feedback,. etc.) This is measured through audio recordings and brain activation patterns during magnetoencephalography.

  3-4 hours after intervention

Study Arms (2)

Single dose of aripiprazole

ACTIVE COMPARATOR

Single dose of aripiprazole, 10mg administered orally. Participant and administrator will be blinded.

Drug: Aripiprazole 10 MG

Placebo dose

PLACEBO COMPARATOR

A single placebo dose will be administered.

Drug: Placebo

Interventions

Aripiprazole 10 MG DRUG

The effects of aripiprazole on stuttering and various behavioral and neural outcomes will be studied compared to placebo.

Single dose of aripiprazole

Placebo DRUG

Placebo will be compared against aripiprazole for effect on stuttering and various behavioral and neural markers.

Placebo dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• native speakers of American English
• for adults who stutter, presence of stuttering will be confirmed, with onset before age 6 years
• Normal hearing
• Ages of 18 to 65 years
• healthy adults without hearing-language difficulties

You may not qualify if:

• self-reported speech-language-hearing difficulties other than stuttering
• self-reported neurological or psychological problems
• other medications (drugs that affect dopaminergic system and/or benzodiazepines)

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• University of Washington: collaborator

Study Sites (1)

Biomagentic Imaging Lab

San Francisco, California, 94143, United States

RECRUITING

Related Publications (11)

• Toyomura A, Miyashiro D, Kuriki S, Sowman PF. Speech-Induced Suppression for Delayed Auditory Feedback in Adults Who Do and Do Not Stutter. Front Hum Neurosci. 2020 Apr 24;14:150. doi: 10.3389/fnhum.2020.00150. eCollection 2020.

  PMID: 32390816 BACKGROUND

• Beal DS, Quraan MA, Cheyne DO, Taylor MJ, Gracco VL, De Nil LF. Speech-induced suppression of evoked auditory fields in children who stutter. Neuroimage. 2011 Feb 14;54(4):2994-3003. doi: 10.1016/j.neuroimage.2010.11.026. Epub 2010 Nov 21.

  PMID: 21095231 BACKGROUND

• Beal DS, Cheyne DO, Gracco VL, Quraan MA, Taylor MJ, De Nil LF. Auditory evoked fields to vocalization during passive listening and active generation in adults who stutter. Neuroimage. 2010 Oct 1;52(4):1645-53. doi: 10.1016/j.neuroimage.2010.04.277. Epub 2010 May 7.

  PMID: 20452437 BACKGROUND

• Daliri A, Max L. Stuttering adults' lack of pre-speech auditory modulation normalizes when speaking with delayed auditory feedback. Cortex. 2018 Feb;99:55-68. doi: 10.1016/j.cortex.2017.10.019. Epub 2017 Nov 13.

  PMID: 29169049 BACKGROUND

• Daliri A, Max L. Modulation of auditory processing during speech movement planning is limited in adults who stutter. Brain Lang. 2015 Apr;143:59-68. doi: 10.1016/j.bandl.2015.03.002. Epub 2015 Mar 18.

  PMID: 25796060 BACKGROUND

• Daliri A, Max L. Electrophysiological evidence for a general auditory prediction deficit in adults who stutter. Brain Lang. 2015 Nov;150:37-44. doi: 10.1016/j.bandl.2015.08.008. Epub 2015 Aug 31.

  PMID: 26335995 BACKGROUND

• Park CH, Park TW, Yang JC, Lee KH, Huang GB, Tong Z, Park MS, Chung YC. No negative symptoms in healthy volunteers after single doses of amisulpride, aripiprazole, and haloperidol: a double-blind placebo-controlled trial. Int Clin Psychopharmacol. 2012 Mar;27(2):114-20. doi: 10.1097/YIC.0b013e3283502773.

  PMID: 22241281 BACKGROUND

• Tran NL, Maguire GA, Franklin DL, Riley GD. Case report of aripiprazole for persistent developmental stuttering. J Clin Psychopharmacol. 2008 Aug;28(4):470-2. doi: 10.1097/JCP.0b013e31817ea9ad. No abstract available.

  PMID: 18626285 BACKGROUND

• Kim BU, Kim HW, Park EJ, Kim JH, Boon-Yasidhi V, Tarugsa J, Reyes A, Manalo SG, Joung YS. Long-Term Improvement and Safety of Aripiprazole for Irritability and Adaptive Function in Asian Children and Adolescents with Autistic Disorder: A 52-Week, Multinational, Multicenter, Open-Label Study. J Child Adolesc Psychopharmacol. 2022 Sep;32(7):390-399. doi: 10.1089/cap.2022.0004.

  PMID: 36112116 BACKGROUND

• Maguire GA, Nguyen DL, Simonson KC, Kurz TL. The Pharmacologic Treatment of Stuttering and Its Neuropharmacologic Basis. Front Neurosci. 2020 Mar 27;14:158. doi: 10.3389/fnins.2020.00158. eCollection 2020.

  PMID: 32292321 BACKGROUND

• Alm PA. The Dopamine System and Automatization of Movement Sequences: A Review With Relevance for Speech and Stuttering. Front Hum Neurosci. 2021 Dec 2;15:661880. doi: 10.3389/fnhum.2021.661880. eCollection 2021.

  PMID: 34924974 BACKGROUND

MeSH Terms

Conditions

Stuttering

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• John Houde, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Srikantan Nagarajan, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Ludo Max, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalie Brunwin, MS

CONTACT

4154766888; snl-bil@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2025
• First Posted: October 14, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)