Stanford, CANCT05546554Now EnrollingIRB Ready

Autism Clinical Trial in Stanford, CA

Access cutting-edge autism treatment through this phase 2 clinical trial at a research site in Stanford. Study-provided care at no cost to qualified participants.

Sponsored by Stanford University

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Expert Care in Stanford

Access autism specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related autism treatment provided free

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Check if you qualify for this autism clinical trial in Stanford, CA

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Why Participate?

  • No-Cost Study Care

  • Local to Stanford

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Stanford site if eligible
  4. 4Begin participation

About This Autism Study in Stanford

The purpose of this study is to examine the effect of suvorexant on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Suvorexant is a selective, dual orexin receptor antagonist (DORA) used for the treatment of sleep onset difficulties and/or sleep maintenance. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of suvorexant on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.

Sponsor: Stanford University

Who Can Participate

Inclusion Criteria

Participants will meet the following
Outpatients between 13 and 17 years of age at time of consent
Diagnostic and Statistical Manual, 5th edition (DSM-5) criteria for Autism Spectrum Disorder (ASD) on the basis of clinical evaluation, confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) or the Childhood Autism Rating Scale, Second Edition (CARS-2)
Males and females
Availability of polysomnography (PSG) and/or actigraphy data
Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with a score of 41 or higher and sleep efficiency of 85% or less and/or total sleep time less than 7 hours and/or wake after sleep onset of more than 30 minutes as measured by polysomnography (PSG) or actigraphy
care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interacts with participant on a regular basis
stable medications for at least 2 weeks, with the exception of Prozac which is required to be stable for at least 4 weeks
no planned changes in psychosocial and biomedical interventions during the trial
willingness to provide additional saliva samples and participate in key study procedures (i.e., safety measurements every visit, PSG at weeks 4 and 8, and wear the actigraphy watch for 2 weeks before the beginning of trial as well as during the 8 weeks of the trial).
requirement of dual protection contraception use in females who are sexually active and are of childbearing potential. Dual use contraceptive methods involve the use of both a hormonal method (oral contraceptives, long-acting reversible contraceptives, etc.) and a barrier method (condoms).

Exclusion Criteria

Participants will be excluded if one or more of the following is met
active suicidal ideation or DSM-5 diagnosis of severe depression, substance use disorder, schizophrenia, schizoaffective disorder, or psychotic disorder
unstable medical problems: migraine, asthma, seizure disorder, significant physical illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology), obstructive sleep apnea and severe hepatic insufficiency
evidence of a metabolic, or infectious etiology for the participant's autism on the basis of medical history, neurologic history, and available tests for inborn errors of metabolism
pregnant or sexually active females not using a reliable method of contraception (urinary tests for pregnancy will be employed in this study)
Benzodiazepines, antiepileptic medications when prescribe for seizure disorder/epilepsy, melatonin and centrally-acting antihistamines
history of hypersensitivity to suvorexant
history of severe side effects from suvorexant
history of adequate trial of suvorexant
current use of any medications known to interact with suvorexant such as medications inhibiting CYP3A
history of narcolepsy

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Stanford?

Yes, this clinical trial (NCT05546554) has an active research site in Stanford, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Autism Treatment Options in Stanford, CA

If you're searching for autism treatment options in Stanford, CA, this clinical trial (NCT05546554) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Stanford research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced autism specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all autism clinical trials near you to find additional studies recruiting in your area.

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