Dopamine and Sensorimotor Function in Stuttering

NCT ID: NCT07215884

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stuttering, Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Single dose of aripiprazole

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

Group Type ACTIVE_COMPARATOR

Aripiprazole 10 MG

Intervention Type DRUG

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

Placebo dose

A single placebo dose will be administered.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Aripiprazole 10 MG

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Houde, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Srikantan Nagarajan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Ludo Max, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Biomagentic Imaging Lab

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Natalie Brunwin, MS

Role: CONTACT

4154766888

Facility Contacts

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Natalie Brunwin, MS

Role: primary

415-476-6888

References

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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.

Reference Type BACKGROUND
PMID: 32390816 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21095231 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20452437 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29169049 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25796060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26335995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22241281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18626285 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36112116 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32292321 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34924974 (View on PubMed)

Other Identifiers

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R21DC021557

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R21DC021557-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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