Improving Driving in Young People With Autism Spectrum Disorders

Phase 4

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Drug: Buspirone

• Registration Number: NCT03538431
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-05-24
• Study First Posted: 2018-05-29
• Study Start: 2018-10-31
• Primary Completion: 2019-12-16
• Study Completion: 2019-12-16
• Results First Submitted: 2021-01-29
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-17
• Last Update Submitted: 2021-03-17
• Results First Posted: 2021-03-18
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Buspirone	Buspirone	These subjects will receive buspirone prior to engaging in the driving simulation.
Unmedicated	Buspirone	These subjects will take no medication prior to engaging in the driving simulation

Primary Outcome Measures

Name	Time	Method
Heart Rate	Up to 6 weeks	Hyperarousal will be measured by heart rate during participants' time in the driving simulation.
Driving Performance - Measured by Mean Off-Road Glance Duration	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. Eye movement behavior (measured by glance duration) during the driving simulation was manually coded on a frame-by-frame basis from recorded video by trained coders for all cases where usable video recordings were available for both the medicated and non-medicated driving simulation sessions per participant.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States