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RecruitingNCT07215884Updated Aug 19, 2026

Dopamine and Sensorimotor Function in Stuttering

A Phase 1 interventional study of Aripiprazole 10 MG and Placebo in Stuttering, Adult, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by University of California, San Francisco · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the detailed description

Stuttering is a disorder of speech fluency that affects 3.5 million people in the USA alone. The goal of this project is to assess whether fluency ehnancement with auditory feedback manipulations or with pharmacological agents that regulate dopamine uptake improve the sensorimotor functions of speech feedback prediction and processing in stuttering.

This study may lay the foundation for stuttering treatments that combine dopamine regulators and behavioral treatments. Aripiprazole is an FDA-approved anti-psychotic typically used for treatment of schizophrenia or acute manic episodes. A typical dose is 10-15 mg per day, given daily for treatment. In this study, one 10 mg dose will be given. The usage in this study is purely investigational (experimental) and not FDA approved.

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Conditions studied

  • Stuttering, Adult

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Keywords

  • Stuttering
  • Aripiprazole
  • Adults with Stuttering
  • Speech Fluency
  • Auditory Feedback
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In context

Stuttering

74 studies on the registry are indexed under Stuttering; 23 are open to participants now.

This study's planned enrollment of 25 is below the median of 44 across 57 interventional studies indexed under Stuttering.

Browse Stuttering studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
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Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
25 participants (estimated)

Study arms

  • Active comparator
    Single dose of aripiprazole

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

    Drug: Aripiprazole 10 MG

  • Placebo comparator
    Placebo dose

    A single placebo dose will be administered.

    Drug: Placebo

Interventions

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

  • DrugPlacebo

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3-4 hours after intervention dose is delivered

  2. 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.

    Time frame: 3-4 hours after intervention

  3. 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.

    Time frame: 3-4 hours after intervention

  4. 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.

    Time frame: 3-4 hours after intervention

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Study locations

1 of 1 sites recruiting
  • Biomagentic Imaging Lab
    San Francisco, California 94143, United States
    Recruiting
    • Natalie Brunwin, MS · Contactsnl-bil@ucsf.edu · 415-476-6888
    • John Houde, PhD · Principal investigator
    • Srikantan Nagarajan, PhD · Principal investigator
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References and documents

Publications

  • 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. PubMed 32390816 ↗
  • 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. PubMed 21095231 ↗
  • 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. PubMed 20452437 ↗
  • 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. PubMed 29169049 ↗
  • 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. PubMed 25796060 ↗
  • 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. PubMed 26335995 ↗
  • 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. PubMed 22241281 ↗
  • 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. PubMed 18626285 ↗
  • 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. PubMed 36112116 ↗
  • 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. PubMed 32292321 ↗
  • 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. PubMed 34924974 ↗

Individual participant data

Plan to share: Yes — Audio and video recordings to verify presence of stuttering will be shared with investigators at University of Washington. De-identified MEG data or results may also be shared with University of Washingotn.

Supporting information: Study protocol, Statistical analysis plan

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07215884
Responsible party
Sponsor
First posted
Oct 14, 2025
Start date
Sep 30, 2025
Primary completion
Jun 30, 2027 (estimated)
Completion
Aug 30, 2027 (estimated)
Last update
Aug 19, 2026

Study contacts

Natalie Brunwin, MS
Contact
snl-bil@ucsf.edu
4154766888
John Houde, PhD
principal investigator · University of California, San Francisco
Srikantan Nagarajan, PhD
principal investigator · University of California, San Francisco
Ludo Max, PhD
principal investigator · University of Washington

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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