Phase 4
N=26
Improving Driving in Young People With Autism Spectrum Disorders
Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03538431 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Driving Performance - Measured by Mean Off-Road Glance Duration — 0.85; 0.90 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Buspirone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Driving Performance - Measured by Mean Off-Road Glance Duration |
0.85; 0.90 | — |
| PRIMARY Heart Rate |
81.78; 82.74 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03538431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.