40 Participants Needed

Aripiprazole for Stuttering

NB
Overseen ByNatalie Brunwin, MS
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of California, San Francisco

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how aripiprazole, a medication, affects adults who stutter. Stuttering disrupts smooth speech, and the researchers aim to explore how this drug might improve fluency by studying the brain's sensorimotor pathways, which process movement and speech. Participants will receive either a single dose of aripiprazole or a placebo (a pill with no active medication) to compare effects. Those who have stuttered since before age 6, are native speakers of American English with normal hearing, and have no other speech or neurological issues might be a good fit. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking medications that affect the dopaminergic system or benzodiazepines to participate in this trial.

Is there any evidence suggesting that aripiprazole is likely to be safe for humans?

Research shows that aripiprazole has been tested for safety in many patients, particularly those with schizophrenia, bipolar disorder, and depression. In these studies, researchers carefully monitored side effects. Common side effects included nausea, dizziness, and insomnia. More serious side effects, though less common, included movement problems like tardive dyskinesia, which can affect speech.

Aripiprazole is already approved by the FDA for certain mental health conditions, indicating a known level of safety in these treatments. However, this study explores a new use, so the specific effects on stuttering remain under investigation. Monitoring side effects remains crucial with any medication.12345

Why do researchers think this study treatment might be promising for stuttering?

Unlike the standard treatments for stuttering, which often include speech therapy and medications like antiepileptics or dopamine blockers, aripiprazole offers a novel approach. Aripiprazole works as a partial dopamine receptor agonist, which means it can stabilize dopamine levels more precisely than traditional medications. This unique mechanism might provide better control over speech fluency with potentially fewer side effects. Researchers are excited about its potential to offer a more effective and targeted treatment for individuals struggling with stuttering.

What evidence suggests that aripiprazole might be an effective treatment for stuttering?

Studies have shown that aripiprazole, a medication often used for conditions like Tourette's syndrome, might help with stuttering. Research suggests it works by blocking certain brain chemicals, especially dopamine, which may affect speech fluency. Some reports noted improvements in stuttering symptoms with aripiprazole. Additionally, growing evidence indicates that similar medications targeting dopamine can reduce stuttering severity. While more research is needed, these findings suggest that aripiprazole could be promising for people who stutter. In this trial, participants will receive either a single dose of aripiprazole or a placebo to evaluate its effectiveness in treating stuttering.678910

Who Is on the Research Team?

JH

John Houde, PhD

Principal Investigator

University of California, San Francisco

SN

Srikantan Nagarajan, PhD

Principal Investigator

University of California, San Francisco

LM

Ludo Max, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This clinical trial is for adults who have a stuttering disorder, affecting their speech fluency. Specific eligibility criteria are not provided, but typically participants would need to be in good general health and not taking conflicting medications.

Inclusion Criteria

Native speakers of American English
My hearing is normal.
I am a healthy adult with no hearing or language problems.
See 2 more

Exclusion Criteria

Self-reported neurological or psychological problems
I have speech or hearing issues, but I do not stutter.
I am not taking drugs that affect the dopamine system or benzodiazepines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single 10 mg dose of aripiprazole or placebo

1 day
1 visit (in-person)

Assessment

Participants undergo magnetoencephalography to measure auditory cortical activity and speech behavior

3-4 hours after intervention
1 visit (in-person)

Follow-up

Participants are monitored for any delayed effects or adverse reactions post-intervention

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Aripiprazole
Trial Overview The study is testing the effects of a medication called Aripiprazole at a dose of 10 MG compared to a placebo. The goal is to understand how this drug may influence sensorimotor pathways involved in stuttering.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Single dose of aripiprazoleActive Control1 Intervention
Group II: Placebo dosePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

University of Washington

Collaborator

Trials
1,858
Recruited
2,023,000+

Citations

Dopamine and Sensorimotor Function in StutteringThis study is being done to understand the effect of aripiprazole on adults who stutter. Stuttering is a disorder that affects speech fluency. This study ...
2.clinicaltrials.ucsf.educlinicaltrials.ucsf.edu/stuttering
UCSF Stuttering Clinical Trials — San Francisco Bay AreaThis study is being done to understand the effect of aripiprazole on adults who stutter. Stuttering is a disorder that affects speech fluency.
Case Report of Aripiprazole in the Treatment of Adolescent ...... It is FDA-approved for Tourette's in children and adults. There are published case reports examining the safety and efficacy in stuttering ( ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/31812095/
Efficacy of aripiprazole in severe, persistent, sociallyEfficacy of aripiprazole in severe, persistent, socially- and occupationally-impairing developmental stuttering.
The Pharmacologic Treatment of Stuttering and Its ...A growing body of evidence suggests that dopamine antagonist medications are effective in reducing the severity of stuttering symptoms.
ABILIFY (aripiprazole) - accessdata.fda.govABILIFY has been evaluated for safety in 1,686 patients (6 to 18 years) who participated in multiple-dose, clinical trials in schizophrenia, bipolar mania, ...
Aripiprazole (oral route) - Side effects & dosageAripiprazole is used alone or together with other medicines to treat mental conditions such as bipolar I disorder (manic-depressive illness), major depressive ...
Abilify (Aripiprazole): Side Effects, Uses, Dosage ...Abilify is a prescription medicine used to treat the symptoms of schizophrenia, bipolar I disorder (manic depression), and major depressive disorder.
Aripiprazole Side Effects: Common, Severe, and MoreOne risk of using antipsychotic drugs long-term is tardive dyskinesia, a movement disorder that can affect your speech. But studies have ...
Aripiprazole: Uses, Dosage, Side Effects, WarningsAripiprazole may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use. To make sure ...
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