Driving to Distraction

Transcription

1 Driving to Distraction New Research on the Impact of ADHD and ADHD Medications on Driving performance Daniel J. Cox, Ph.D., A.B.P.P Professor, Departments of Psychiatric and Internal Medicine Director, Center for Behavioral Medicine Research University of Virginia Health System Charlottesville, VA Disclosure Dr Cox has served as a speaker and consultant to: Janssen-Ortho, NIH, Eli Lilly, McNeil, and Shire. Program objectives At the presentation s conclusion, health care professionals will be able to: distinguish the variety and complexity of driving skills affected by ADHD identify driving as a privilege of ADHD drivers requiring special attention from parents, patients and clinicians assess the body of evidence suggestive of optimal medical management of this at-risk population

2 Looking beyond school performance ADHD is associated with an increased risk for accidents, especially bicycle and pedestrian ADHD among adolescents is associated with nearly double the ER visits and days in the hospital, and 1% more medical expenses than non-adhd peers. Leibson, JAMA. 1;85:6-66 Jensen. J Am Acad Child Adolesc Psychiatry. 1988;7(6): DiScala. Pediatrics. 1998;1(6): Functional Impairment in Patients With ADHD Compared to Those Without Repeat a grade < high school Teen pregnancy ADHD Normal STD Substance abuse Accident prone Serious car accident Arrested Incarcerated Fired from job % 1% % 3% 4% 5% 6% Subjects (%) 1. Barkley. Attention-deficit hyperactivity disorder. A handbook for diagnosis and treatment, 1998;. Barkley et al. JAACAP 199; 3. Biederman et al. Arch Gen Psych 1996; 4. Weiss et al. JAACAP 1985; 5. Satterfield, Schell. JAACAP 1997; 6. Biederman et al. Am J Psych ADHD and Driving: A Dangerous Mix Motor vehicle accidents are the leading cause of death in adolescents, and ADHD is a major contributor. 1 Young drivers with ADHD are to 4 times more likely to have traffic accidents times as likely to have injuries. 3 4 times as likely to be at fault. 6 to 8 times more likely to have their license suspended.,3 This extends to females as well as males National Highway Traffic Safety Administration. Ann Emerg Med. 1997;9: Barkley RA et al. Pediatrics. 1993;9: Barkley RA et al. Pediatrics. 1996;98: Cox DJ et al. J Nerv Ment Dis. ;188: Nada-Raja S et al. JAACAP. 1997;36:515-5.

3 ADHD and Driving: A Dangerous Mix Motor vehicle collisions are the leading cause of death in adolescents, and ADHD is a major contributor. 1 Young drivers with ADHD are to 4 times more likely to have traffic collision 3 times as likely to have injuries. 3 4 times as likely to be at fault. 6 to 8 times more likely to have their license suspended.,3 This extends to females as well as males National Highway Traffic Safety Administration. Ann Emerg Med. 1997;9: Barkley RA et al. Pediatrics. 1993;9: Barkley RA et al. Pediatrics. 1996;98: Cox DJ et al. J Nerv Ment Dis. ;188: Nada-Raja S et al. JAACAP. 1997;36: Studies to Assess the Effect of Methylphenidate on Driving Performance in ADHD Studies assessed the effect of ADHD treatment on driving performance. STUDY 1: Simulated driving study of RITALIN vs placebo 1 STUDY : Simulated driving study of CONCERTA Limitation: vs RITALIN All small sample sizes Strength: STUDY findings 3: On-road consistent driving study across of different CONCERTA research On assistants, vs Off medication samples 3 and testing conditions STUDY 4: Simulated and on-road driving study of CONCERTA vs ADDERALL XR vs Placebo 4 1. Cox DJ et al. J Nerv Ment Disord. ;188: Cox DJ et al. J Am Acad Child Adolesc Psychiatry. 4;43(3) Cox DJ et al. J Am Board Fam Pract. 4;17: Cox DJ et al. Poster presented at APA 5; manuscript in preparation. Virtual Reality Driving Simulator 165 degree visual field Updates every 6 msec Performance feedback Auditory Kinesthetic Visual Tracks 1 performance variables

4 STUDY 1 Simulated Driving Study of RITALIN vs Placebo Cox DJ et al. J Nerv Ment Disord. ;188:3-34. STUDY 1: RITALIN vs Placebo in Driving Simulator Double-blind, crossover study design RITALIN vs placebo ADHD vs nonadhd control college students 7 male drivers with ADHD and 6 non-adhd male drivers aged 19 to 5 years Driving assessed 1.5 to hours postdose Cox DJ et al. J Nerv Ment Disord. ;188:3-34. STUDY 1: RITALIN vs Placebo Placebo ADHD improvement, P<.5. RITALIN ADHD Placebo Control Placebo ADHD RITALIN Control RITALIN Average driving Lower score denotes better driving performance. Cox DJ et al. J Nerv Ment Disord. ;188:3-34.

5 STUDY Simulated Driving Study of CONCERTA vs RITALIN Cox DJ et al. J Am Acad Child Adolesc Psychiatry. 4;43(3) STUDY : CONCERTA vs RITALIN in Driving Simulator Open-label, crossover study design. Subjects received CONCERTA at 8: AM or RITALIN at 8: AM, 1: PM, and 4: PM. Subjects were 6 male adolescents with ADHD. Aged 16 to 19 years Stimulant responders, daily drivers Driving performance was assessed at : PM, 5: PM, 8: PM, and 11: PM. Cox DJ et al. J Am Acad Child Adolesc Psychiatry. 4;43(3) STUDY : CONCERTA vs RITALIN 6 5Equivalent performance to male drivers 8+ yrs Equivalent performance to male drivers yrs : PM 5: PM 8: PM 11: PM Time P<.1 (8: PM). Cox DJ et al. J Am Acad Child Adolesc Psychiatry. 4;43(3) CONCERTA qd RITALIN tid Average driving Lower score denotes better driving performance.

6 STUDY 3 On-road Driving Study of CONCERTA On vs Off Medication Cox DJ et al. J Am Board Fam Pract. 4;17: STUDY 3: On-Road Driving Performance with CONCERTA Open-label, crossover study design. Subjects drove a standard course twice once ON and once OFF medication. The 16-mile course incorporated rural, highway, and urban streets. Subjects included 1 male drivers with ADHD: Mean age=17.8 years Stimulant responders, daily drivers Driving performance was assessed during daylight, at the same time for each condition. Raters were blinded to treatment state. Cox DJ et al. J Am Board Fam Pract. 4;17: STUDY 3: On-Road Driving Performance with CONCERTA Blinded Rater Results No effect on speed control, although speeding was the most frequent error. Impulsive errors were infrequent and not affected. Medication reduced inattentive driving errors (P<.1). Total Number of Driving Errors 1 8 Improvement correlated with 6 mg/kg dose r=.6, p<.1 4 Speed Control Medication No Medication P<.1 Impulsive Inattention Cox DJ et al. J Am Board Fam Pract. 4;17:35-39.

7 STUDY 4 Simulated and On-road Driving Study of CONCERTA vs ADDERALL XR Cox DJ et al. Poster presented at APA 5; manuscript in preparation. STUDY 4: CONCERTA vs ADDERALL XR Objective and Methods Double-blind, placebo-controlled, crossover study 35 Stimulant responsive adolescent drivers with ADHD Aged 16 to 19 years 19 males/16 females 1 Combined, 1 Inattentive, Hyperactive subtypes Laboratory assessments At 5, 8, 11 PM: High-fidelity driving simulator & Neuropsych testing At Midnight: On-road drive with rater blind to medication condition Group B STUDY 4: CONCERTA vs ADDERALL XR Study Design CONCERTA Dosing 4 Lab Study Days: ADDERALL XR On 1 CONCERTA the assumptions that: 1 ADDERALL mg of MPH XR is equal potency to 1 mg of Adderall. 1% Lab 1 Lab Lab 3 Lab 4 1 Placebo of MPH is lost in the Concerta capsule, then 3mg 1 of Off Aderall XR should be equivalent to 7mg ov Concerta ADDERALL XR CONCERTA Group A 15 mg 3 mg 36 mg 7 mg CONCERTA 36 mg 7 mg ADDERALL XR 15 mg 3 mg Days Cox DJ et al. Poster presented at APA 5; manuscript in preparation.

8 STUDY 4: CONCERTA vs ADDERALL XR Outcome Overview No Gender by condition interaction No ADHD Subtype by condition interaction Side Effect Scale: Total Scores Adderall Concerta Baseline Half Dose Full Dose Total score Consistent 14 with Shire FDA data documentation indicating No 1 improvement in efficacy with adolescents when going from 1 to 3 mg with Adderall XR STUDY 4: CONCERTA vs ADDERALL XR Conners Brief Rating Scale Total Score Adderall Concerta Baseline Half Dose Full Dose

9 STUDY 4: CONCERTA vs ADDERALL XR 1.5 Equivalent performance to male drivers yrs Equivalent performance to male drivers yrs CONCERTA ADDERALL XR Placebo - Contrasts 5: PM 8: PM 11: PM Medication vs. placebo; P=.1 Time Concerta vs. placebo; P=.1 Contrasts: Medication vs placebo P=.1; CONCERTA vs placebo P=.1; ADDERALL XR vs placebo Adderall P=.4; CONCERTA XR vs. placebo; vs ADDERALL P=.4 XR P=.3. Cox DJ et al. Poster presented Concerta at APA 5; manuscript vs. Adderall in preparation. XR ; P=.3 Study 4: Subjective ratings (-5) of driving ability post drive CONCERTA ADDERALL XR Placebo 5: PM 8: PM 11: PM CONCERTA vs Adderall XR Impaired Neuro-Cognitive Score (Distractibility and Visual Memory) Impaired Neuro-Cognitive Score Contrasts OROS MPH vs. Plcebo; P<.1 Adderall XR vs. placebo; P=.4 a 5: PM 8: PM 11: PM Plcebo Adderall XR CONCERTA qd Average driving Time Academy of Clinical Neuropsychology, 6, Nov. (In Press)

10 Rebound Effects Do individuals perform worse on days having taken medication, once that medication wears of, than they would if they had never taken any medication Studies to Assess the Effect of Methylphenidate on Driving Performance in ADHD Conclusions Methylphenidate treatment improves driving performance in adolescents with ADHD. CONCERTA demonstrates real-life, on-road driving improvements. Once-daily CONCERTA was more effective than RITALIN tid in driving performance of adolescents with ADHD. Overall, CONCERTA was more effective than ADDERALL XR in driving performance of adolescents with ADHD. Who is at GREATEST Risk? More severe ADHD Those who report taking more risks while driving >1 speeding ticket Driving Specific Risk Taking Scale Those with less medication coverage

11 Take-Home Messages 1. Talk to your patients about increased risk, costs, and legal implications of driving mishaps. Assure patients and parents of the beneficial effects of medication and the need to take it daily 3. Only drive when medication becomes effective Specific Driving Variable Veering Across Midline Concerta Better than. Placebo Concerta better than Adderall XR Inattentive Driving Errors P=.8 Adderall XR better than Placebo Off Road Speeding SD Speed Inappropriate Braking P=. Hyperactive Driving Errors P=.1 Impulsive Driving Errors P=. P=.5 P=.8 P=.6 P=.4 Time at Stop Sign Time executing left turn P=.3 P=.6 P=.9