Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
26 participants
INTERVENTIONAL
2023-08-09
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Zolpidem, then Placebo
Participants will first receive Zolpidem for a 4-week period. A 5 mg dose of Zolpidem will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated.
Participants will then receive Placebo (fake tablet) for a 4-week period. A 5 mg dose of matching Placebo will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated.
Zolpidem
5mg (and up to10mg) Diphenhydramine given orally
Placebo
Matching Placebo given orally
Placebo, then Zolpidem
Participants will first receive Placebo (fake tablet) for a 4-week period. A 5 mg dose of matching Placebo will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated.
Participants will then receive Zolpidem for a 4-week period. A 5 mg dose of Zolpidem will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated.
Zolpidem
5mg (and up to10mg) Diphenhydramine given orally
Placebo
Matching Placebo given orally
Interventions
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Zolpidem
5mg (and up to10mg) Diphenhydramine given orally
Placebo
Matching Placebo given orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Outpatients between 8 and 17 years of age with only 12- 17 years of age at time of consent during year 1
* 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)
* 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
* 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) and 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)
* individuals taking beta-blockers (local or systemic), benzodiazepines, antiepileptic medications, melatonin, antihistamines and antidepressants
* history of hypersensitivity to zolpidem
* history of severe side effects from zolpidem
* history of adequate trial of zolpidem
* current use of any medications known to interact with zolpidem such as medications inhibiting CYP3A4 and CYP1A2
* history of complex sleep-related behaviors
* individuals using alcohol, marijuana and other substances.
8 Years
17 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Stanford University
OTHER
Responsible Party
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Antonio Hardan
Professor of Psychiatry and Behavioral Sciences
Principal Investigators
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Antonio Y. Hardan, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Stanford, California, United States
Countries
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Central Contacts
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Facility Contacts
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Ryan Villacrucis
Role: primary
Robin Libove, BS
Role: backup
Other Identifiers
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IRB-67221
Identifier Type: -
Identifier Source: org_study_id