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Improving Driving in Young People With Autism Spectrum Disorders

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ClinicalTrials.gov Identifier: NCT03538431
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital

Brief Summary:

This study will examine the effects of treatment with the anti-anxiety medicine buspirone on driving performance (eye tracking) in individuals with high-functioning autism spectrum disorder (HF-ASD).

The study consists of an Assessment Visit at Massachusetts General Hospital (MGH), as well as two Driving Simulation visits that will take place at Massachusetts Institute of Technology (MIT). Subjects will be given buspirone and asked to take the medication for the two days preceding the Driving Simulation Visit.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: Buspirone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Improving Driving in Young People With Autism Spectrum Disorders
Actual Study Start Date : October 31, 2018
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Buspirone before Simulation 1
These subjects will receive and be instructed to take the buspirone for the 2 days preceding their first driving simulation visit. They will not take buspirone before their 2nd driving simulation visit.
Drug: Buspirone
Buspirone is an atypical anxiolytic medication.

Experimental: Buspirone before Simulation 2
These subjects will receive and be instructed to take the buspirone for the 2 days preceding their second driving simulation visit. They will not take buspirone before their 1st driving simulation visit.
Drug: Buspirone
Buspirone is an atypical anxiolytic medication.




Primary Outcome Measures :
  1. Driving Performance [ Time Frame: Up to 6 weeks ]
    Driving performance will be analyzed using eye tracking in individuals with Autism Spectrum Disorder while on the anti-anxiety medication buspirone and while not on buspirone.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, ages 18-24, with a diagnosis of DSM-V Autism Spectrum Disorder
  • Has a valid Driver's License

Exclusion Criteria:

  • Major sensorimotor handicaps (e.g. deafness, blindness)
  • Individuals who have never held a valid driver's license
  • Intellectual Deficiency (Verbal Comprehension Index < 80)
  • Inadequate command of the English language
  • Subjects with any clinically meaningful medical or psychiatric condition as determined by the investigator
  • Individuals who are currently taking a monoamine oxidase inhibitor (MAOI) for any reason
  • Pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538431


Contacts
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Contact: Elizabeth Noyes, BA 617-726-4651 enoyes@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Elizabeth Noyes, BA    617-726-4641    enoyes@partners.org   
Contact: Haley Driscoll, BA    617-724-2551    hdriscoll2@partners.org   
Principal Investigator: Joseph Biederman, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Massachusetts Institute of Technology

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Responsible Party: Joseph Biederman, MD, Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03538431     History of Changes
Other Study ID Numbers: 2018-P-000900
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joseph Biederman, MD, Massachusetts General Hospital:
Autism Spectrum Disorder
ASD
Anxiety

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Disease
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Buspirone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action