FORENSIC TOXICOLOGY

A pediatric ADHD trial observed treatment effects through 12 hours after patch application, although patches were removed at nine hours. Patch removal and the end of a measured behavioral effect were therefore not the same event.

Study design and population

Cutler and colleagues studied a dextroamphetamine transdermal system in children and adolescents aged 6–17. An open-label optimization phase selected a tolerated effective dose before a randomized, double-blind crossover comparison with placebo. Patches were worn for nine hours. Classroom ratings and a mathematics performance measure assessed effects across the day.

Findings that matter

Active patches significantly improved classroom symptom ratings relative to placebo. Significant differences were observed from two hours through 12 hours after application, including after removal. Performance on the mathematics task also favored treatment over that interval. These are observations at scheduled assessment times. They do not show an instantaneous onset at exactly two hours or an exact offset immediately after the final observation.

What remains unproven

The optimization phase selected a dose before controlled testing, so the results are not a prediction of every child’s first exposure to any patch strength. Laboratory classroom behavior is also different from driving or unsupervised real-world performance. The trial was not designed to derive a plasma or whole-blood concentration threshold for impairment. Nor can the duration be transferred to oral methamphetamine, another formulation or an unidentified stimulant exposure. The evidence supports sustained clinical effects of the tested delivery system under its protocol, while demonstrating why administration history, removal time and assessment time should remain separate when reconstructing an exposure.

Related evidence

See a different formulation and forced-dose ADHD trial.

Primary research

Original study: 10.1089/cap.2021.0107.