Dopamine and Sensorimotor Function in Stuttering

Not Applicable

Recruiting

• Conditions: Stuttering, Adult
• Interventions: Drug: Aripiprazole 10 MG; Drug: Placebo

• Registration Number: NCT07215884
• Lead Sponsor: University of California, San Francisco

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.

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.

Study Timeline

• Study Start: 2025-09-30
• Status Verified: 2025-10
• Study First Submitted: 2025-10-07
• Study First Submitted QC: 2025-10-08
• Last Update Submitted: 2025-10-08
• Study First Posted: 2025-10-14
• Last Update Posted: 2025-10-14
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Single dose of aripiprazole	Aripiprazole 10 MG	Single dose of aripiprazole, 10mg administered orally. Participant and administrator will be blinded.
Placebo dose	Placebo	A single placebo dose will be administered.

Primary Outcome Measures

Name	Time	Method
Pre-speech auditory modulation	3-4 hours after intervention dose is delivered	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.
Speaking Induced Suppression (SIS)	3-4 hours after intervention	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.
Centering	3-4 hours after intervention	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.
Feedback alterations	3-4 hours after intervention	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.

Trial Locations

Locations (1)

Biomagentic Imaging Lab; 🇺🇸 San Francisco, California, United States