Study Results
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Basic Information
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RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2025-09-30
2026-06-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Single dose of aripiprazole
Single dose of aripiprazole, 10mg administered orally. Participant and administrator will be blinded.
Aripiprazole 10 MG
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.
Placebo
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.
Placebo
Placebo will be compared against aripiprazole for effect on stuttering and various behavioral and neural markers.
Eligibility Criteria
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Inclusion Criteria
* 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 neurological or psychological problems
* other medications (drugs that affect dopaminergic system and/or benzodiazepines)
18 Years
65 Years
ALL
Yes
Sponsors
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National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
University of Washington
OTHER
University of California, San Francisco
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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