Measuring the Effect of Amphetamine Extended-Release (DYANAVEL® XR) on Driving Performance in Young Adult Drivers with ADHD Using a Sophisticated Driving Simulation

This study aimed to assess the impact of treatment with a single amphetamine extended-release (Dyanavel® XR; DXR) 20 mg tablet on the driving performance of young adults with clinically established attention-deficit/hyperactivity disorder in a laboratory-based driving simulation environment. This single-center, randomized, double-blind, placebo-controlled study evaluated driving parameters during simulated drives undertaken predose, 45 min postdose, and 10 h postdose. The primary endpoints were safety-related simulator performance measures indexing proximity to a lead vehicle and braking response intensity across eight emergent conflict events per drive that required an attentive response by the driver. The driving simulation used what is believed to be a novel methodology among intervention trials that allowed inattentive drivers to come very close to a lead vehicle during a potential conflict event, but also adjusted lead vehicle dynamics so that a participant would not experience a simulated crash and thus influence their subsequent behavior. The key secondary endpoint was crash frequency during an event at the end of the third drive that did allow an inattentive driver to collide with a lead vehicle. Forty-one male and female drivers aged 18–25 years completed the study: 21 participants in the DXR group and 20 in the placebo group. For DXR-treated participants with a complete evaluable data set (n = 17), statistically significant improvements in the minimum time to collision and mean highest braking intensity occurred across their three drives. These findings appeared as a positive trend when comparing the 45 min postdose drive with participants’ baseline values and at statistically significant levels when comparing the 10 h postdose drive with baseline. Participants with attention-deficit/hyperactivity disorder who took a morning dose of DXR showed a pattern of behavior during simulated driving that was consistent with improved safety-margin behavior (greater time-to-collision) and less abrupt braking responses within the simulation context at 10 h postdose. https://clinicaltrials.gov/study/NCT04027361 .