Psilocybin for Stuttering

Overseen By Eric Jackson, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: NYU Langone Health

Must not be taking: Psychiatric medications

Disqualifiers: Pregnancy, Seizure disorder, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether psilocybin, a compound in certain mushrooms, can safely and effectively reduce stuttering in adults. Researchers aim to determine if it can improve speech fluency and overall well-being in individuals who have struggled with stuttering for some time. Participants will undergo several therapy sessions, including one where they receive psilocybin. Ideal candidates are adults diagnosed with mild to severe stuttering who can attend all sessions and follow study instructions. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in stuttering treatment.

Will I have to stop taking my current medications?

The trial requires participants to stop taking any prohibited medications and supplements for at least 5 elimination half-lives or 14 days, whichever is longer, before the study starts. Psychiatric medications will not be discontinued or changed for the study.

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

Research shows that psilocybin is under investigation for its potential to help with stuttering. Some studies have found that about 10% of people may experience negative effects, such as increased stuttering or reduced speech control. However, others have observed positive effects, including reduced stuttering. Psilocybin is also being studied for other purposes, providing some existing safety information. While much remains to be learned, these studies contribute to understanding how people might react to psilocybin. ^{1 2 3 4 5}

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

Unlike standard treatments for stuttering, which often involve speech therapy and medications like antianxiety drugs, psilocybin offers a novel approach by using a psychedelic compound. Psilocybin works by affecting serotonin receptors in the brain, potentially altering neural pathways related to speech and communication. Researchers are excited about psilocybin because it might provide lasting effects with just a single administration, offering new hope for those who haven't found success with traditional methods.

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

Research suggests that psilocybin might help with stuttering. Some studies have found that about half of the participants reported less stuttering and better speech control after using psilocybin. One study showed that nearly 60% of participants experienced positive changes, such as reduced stuttering. These findings indicate that psilocybin might affect brain areas involved in speech. However, results can vary, and some people reported mixed or no changes. Overall, early evidence shows potential benefits, but more research is needed to confirm these effects. ^{1 2 3 4 6}

Who Is on the Research Team?

Michael Bogenschutz, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults with developmental stuttering. Participants must be willing to undergo psilocybin-assisted therapy and speech therapy. Specific eligibility criteria are not provided, but typically include being in good health and meeting certain medical requirements.

Inclusion Criteria

Are able to provide voluntary informed consent

Are able to read, speak, and understand English, as documented during the informed consent process

I am between 18 and 50 years old.

Exclusion Criteria

My family has a history of certain mental health issues.

Have a known allergy or hypersensitivity to psilocybin or any of the materials contained in the IP used in the study

I don't have allergies or conditions that prevent treatment for high blood pressure, anxiety, or psychosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparatory Therapy

One preparatory therapy session prior to the drug administration session

1 week

1 visit (in-person)

Drug Administration

One 8-hour session where participants receive 25 mg of psilocybin

1 day

1 visit (in-person)

Speech Therapy

Six sessions of speech therapy

6 weeks

6 visits (in-person)

Follow-up Therapy

Two follow-up therapy sessions following the drug administration session

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview

The study tests the safety and potential benefits of psilocybin (a psychedelic compound) combined with speech therapy on improving fluency and reducing struggle in people who stutter. It's a Phase 2a open-label pilot study, meaning everyone gets the treatment without a comparison group.

How Is the Trial Designed?

Group I: Adult stutterers Experimental Treatment 2 Interventions

Participation will occur over an 8-week, 10-session period. Six sessions speech therapy; one preparatory therapy session prior to the drug administration session; one 8-hour drug administration session (25 mg of psilocybin); two follow-up therapy sessions following the drug administration session.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07296328

Effects of Psilocybin on Speech Fluency, Struggle, and ...

This pilot study will assess whether further research to explore the potential benefits of psilocybin-assisted therapy for improving clinical ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11221540/

Psychedelics in developmental stuttering to modulate brain ...

Accordingly, studies of psilocybin have shown promising results in these disorders (Lowe et al., 2022), and reduced overactivation of the DMN could be a key ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0094730X24000263

Stutterers' experiences on classic psychedelics

The most reported effect among Reddit users was reduced stuttering, with half of users reporting a reduction in their stuttering. Users also reported reduced ...

4.

biorxiv.org

biorxiv.org/content/10.1101/2023.04.18.537312v1.full-text

Self-reported effects of classic psychedelics on stuttering

Nearly 60% of participants indicated positive behavioral change (e.g., reduced stuttering, increased speech control), 40% reported positive ...

5.

nyu.edu

nyu.edu/about/news-publications/news/2024/may/can-psychedelics-stop-a-stutter-0.html

Can Psychedelics Help Stutterers?

Negative (9.6%), mixed—positive and negative—(4.8%), and neutral overall experiences (11.6%) were also reported. Half of the posters indicated a ...

6.

ctv.veeva.com

ctv.veeva.com/study/effects-of-psilocybin-on-speech-fluency-struggle-and-brain-activity-in-people-who-stutter

Effects of Psilocybin on Speech Fluency, Struggle, and Brain ...

This pilot study will assess whether further research to explore the potential benefits of psilocybin-assisted therapy for improving clinical ...