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Stuttering, AdultPhase 1NCT07215884

Dopamine and Sensorimotor Function in Stuttering

A Phase 1 study testing Aripiprazole 10 MG in people with Stuttering, Adult, run by University of California, San Francisco at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Stuttering, Adult
What is being tested?
Aripiprazole 10 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteUnited States
Study dates
30 Sep 2025to 30 Aug 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Natalie Brunwin, MS contact

4154766888

snl-bil@ucsf.edu

United States1 site, 1 recruiting

  • Biomagentic Imaging Lab

    San Francisco, California, 94143

    Natalie Brunwin, MS, 415-476-6888, snl-bil@ucsf.edu

    John Houde, PhD

    Recruiting

Other trials in United States

About this study

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.

Being tested
Aripiprazole 10 MG, Placebo
Keywords
Stuttering, Aripiprazole, Adults with Stuttering, Speech Fluency, Auditory Feedback
Medical subject headings
Stuttering

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aripiprazole 10 MGDrug

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

  • PlaceboDrug

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

Study groups in NCT07215884
Study groupRoleWhat they receive
Single dose of aripiprazoleActive comparatorSingle dose of aripiprazole, 10mg administered orally. Participant and administrator will be blinded.
Receives: Drug: Aripiprazole 10 MG
Placebo dosePlacebo comparatorA single placebo dose will be administered.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 3-4 hours after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2025
  2. Study start30 Sep 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07215884
Sponsor's protocol ID
1R21DC021557-01A1
Other IDs
R21DC021557
Status last verified
Aug 2026
First submitted
7 Oct 2025
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Aripiprazole 10 MG in people with Stuttering, Adult, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Natalie Brunwin, MS (4154766888, snl-bil@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre-speech auditory modulation (time frame: 3-4 hours after intervention dose is delivered). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07215884, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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