Dopamine and Sensorimotor Function in Stuttering

University of California San Francisco (UCSF)

Status and phase: Enrolling; Phase 1

Conditions: Stuttering, Adult

Treatments: Drug: Placebo; Drug: Aripiprazole 10 MG

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07215884

R21DC021557 (U.S. NIH Grant/Contract)

1R21DC021557-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Single dose of aripiprazole

Active Comparator group

Description:

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

Treatment:

Drug: Aripiprazole 10 MG

Placebo dose

Placebo Comparator group

Description:

A single placebo dose will be administered.

Treatment:

Drug: Placebo