Poster
137
(#137) Effects of a single dose of amphetamine extended release (DYANAVEL XR) tablet on driving performance in a laboratory simulator of young adult drivers with ADHD
Psych Congress 2025
Abstract: BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is a risk factor for motor vehicle accidents, including injuries and fatalities. The focus of this study was 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 ADHD in a laboratory-based driving simulation environment.
METHOD: This single-center, randomized, double-blind, placebo-controlled study evaluated driving parameters during simulated drives undertaken pre-dose, 45 minutes post-dose and 10 hours post-dose. The primary endpoint variables assessed the risk of colliding with a leading vehicle and the risk of being rear-ended by a following vehicle. The key secondary endpoint was a comparison of crash frequency at the end of the third drive.
RESULTS: 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 the majority of endpoints numerically improved outcomes were observed for DXR vs placebo at both post-dose assessments. For DXR-treated participants with a complete evaluable data set (n = 17), statistically significant improvements in the minimum time to collision (p=0.002), maximum braking force (p=0.003), mean maximum brake force (p=0.005) occurred across their three drives. The crash risk was 2.6 times less in the DXR group than in the placebo group (p=0.18).
CONCLUSION: Participants with ADHD who took a morning dose of DXR showed a trend of less risky subsequent driving behavior during simulated driving that was associated with a decreased relative crash risk 10 hours later.
Short Description: Patients with ADHD are at increased risk for motor vehicle accidents, including injuries and fatalities. This randomized, placebo-controlled study evaluated the effects of DYANAVEL XR (DXR) 20 mg on simulated driving performance in young adults with ADHD. The findings from this study suggest that DXR may reduce risky driving behavior in individuals with ADHD, with effects lasting up to 10 hours post-dose.
Name of Sponsoring Organization(s):
METHOD: This single-center, randomized, double-blind, placebo-controlled study evaluated driving parameters during simulated drives undertaken pre-dose, 45 minutes post-dose and 10 hours post-dose. The primary endpoint variables assessed the risk of colliding with a leading vehicle and the risk of being rear-ended by a following vehicle. The key secondary endpoint was a comparison of crash frequency at the end of the third drive.
RESULTS: 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 the majority of endpoints numerically improved outcomes were observed for DXR vs placebo at both post-dose assessments. For DXR-treated participants with a complete evaluable data set (n = 17), statistically significant improvements in the minimum time to collision (p=0.002), maximum braking force (p=0.003), mean maximum brake force (p=0.005) occurred across their three drives. The crash risk was 2.6 times less in the DXR group than in the placebo group (p=0.18).
CONCLUSION: Participants with ADHD who took a morning dose of DXR showed a trend of less risky subsequent driving behavior during simulated driving that was associated with a decreased relative crash risk 10 hours later.
Short Description: Patients with ADHD are at increased risk for motor vehicle accidents, including injuries and fatalities. This randomized, placebo-controlled study evaluated the effects of DYANAVEL XR (DXR) 20 mg on simulated driving performance in young adults with ADHD. The findings from this study suggest that DXR may reduce risky driving behavior in individuals with ADHD, with effects lasting up to 10 hours post-dose.
Name of Sponsoring Organization(s):
