Improving Driving in Young People With Autism Spectrum Disorders

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Autism Spectrum Disorder

Treatments: Drug: Buspirone

Study type: Interventional

Funder types: Other

Identifiers

NCT03538431

2018-P-000900

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Buspirone

Experimental group

Description:

These subjects will receive buspirone prior to engaging in the driving simulation.

Treatment:

Drug: Buspirone

Unmedicated

Experimental group

Description:

These subjects will take no medication prior to engaging in the driving simulation

Treatment:

Drug: Buspirone