Improving Driving in Young People With Autism Spectrum Disorders

NCT ID: NCT03538431

Last Updated: 2021-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-31
• Study Completion Date: 2019-12-16

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Buspirone

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

Group Type: EXPERIMENTAL

Buspirone

Intervention Type: DRUG

Buspirone is an atypical anxiolytic medication.

Unmedicated

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

Group Type: EXPERIMENTAL

Buspirone

Intervention Type: DRUG

Buspirone is an atypical anxiolytic medication.

Interventions

Buspirone

Buspirone is an atypical anxiolytic medication.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts Institute of Technology

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joseph Biederman, MD

Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018-P-000900

Identifier Type: -

Identifier Source: org_study_id