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Impact of Methylphenidate Delivery Profiles on Driving Performance of Adolescents With Attention-Deficit/Hyperactivity Disorder: A Pilot Study

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ABSTRACT

Objective

Adolescents with attention-deficit/hyperactivity disorder (ADHD) are at high risk for driving accidents. One dose of methylphenidate (MPH) improves simulator driving performances of ADHD-diagnosed adolescents at 1.5 hours post-dose. However, little is known about the effects of different MPH delivery profiles on driving performance throughout the day.

Method

This randomized, crossover, single-blind study compared osmotic, controlled-release oral system (OROS) MPH (Concerta) given q.d. to immediate-release MPH (Ritalin) given in equal doses t.i.d. on driving performance among six male ADHD-diagnosed adolescent drivers aged 16 to 19 years. Under each treatment condition, participants were maintained on their medication dosage for 7 days, then drove a sophisticated driving simulator at 2 p.m., 5 p.m., 8 p.m., and 11 p.m. The primary outcome measure was each participant's computer-quantified Impaired Driving Score (IDS).

Results

IDS worsened in the evenings for participants receiving MPH t.i.d. but remained stable when they received once-daily OROS MPH. Participants performed significantly better when receiving OROS MPH q.d. compared with MPH t.i.d. (F = 9.3, df = 1, p = .004). When MPH was given t.i.d., IDS significantly worsened beginning at 8 p.m. compared to OROS MPH (p = .01).

Conclusions

Participants demonstrated significantly less variability and better driving performance when receiving OROS MPH q.d. compared to MPH t.i.d., particularly in the evenings.

Section snippets

Subjects

Seven male drivers with ADHD, with a mean age of 17.2 ± 1.2 years and 15.8 ± 12.4 months of driving experience, participated in this repeated-measure crossover study (Table 1); one subject (subject 2) dropped out of the study due to the unexpected death of a close friend. Thus, six subjects completed the study. Subjects were recruited through high school nurses and a newspaper advertisement. Inclusion criteria were diagnosis of current ADHD as determined by parent-report questionnaire and

RESULTS

As shown in Figure 1, IDS worsened in the evening for the MPH t.i.d. condition but remained stable for the once-daily OROS MPH condition. ANOVA revealed a significant medication effect (F = 9.3, df = 1, p = .004) and a trend for an interaction (F = 2.2, df = 3, p = .10) but no time effect (F = 1.8, df = 2, p = .17). The mean ± SD IDSs under the OROS MPH q.d. versus MPH t.i.d. conditions were 2 p.m., −0.55 ± 2.3 versus −0.54 ± 3.3 (p = 1.0); 5 p.m., −2.2 ± 0.4 versus −1.04 ± 2.2 (p = .2); 8

DISCUSSION

When adolescent drivers with ADHD were treated with OROS MPH q.d., they demonstrated less variability and performed significantly better throughout the day on objective measures of driving performance than when treated with MPH t.i.d. There were statistically significant differences at 8 p.m. (12 hours postdose), with participants demonstrating significant decay in driving performance while receiving MPH t.i.d.

When participants received OROS MPH q.d., they were significantly less likely to

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      The most frequent medications tested are stimulants ((OROS) methylphenidate, mixed amphetamine salts, lisdexamfetamine dimesylate), but also non-stimulants (atomoxetine) have been tested. Several studies have used randomized, single- or double-blind, placebo-controlled research designs only including ADHD-drivers with a within-subjects crossover design or waiting-list subjects as controls (Cox et al., 2004, 2006, 2012; Barkley et al., 2005; Kay et al., 2009; Biederman et al., 2012). Significant effects of stimulants on behavior which have been reported are less variability and better driving performance (Cox et al., 2004), lesser impulsiveness, lesser variability of steering, improved turn signaling (Barkley et al., 2005), better driving performance, fewer instances of speeding, less erratic speed control, more time executing left turns, less inappropriate use of brakes (Cox et al., 2006), improved, overall driving performance (Kay et al., 2009), and faster reaction time, fewer “accidents”, lower rate of “collisions” (Biederman et al., 2012).

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    This study was funded by a grant from McNeil Consumer & Specialty Pharmaceuticals.

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