Exploring Parameters of Driving Simulation in Relation to Drug Holidays in ADHD Patients

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Attention deficit hyperactivity disorder (ADHD) or syndrome (ADHS) is a symptomatically defined condition that - if untreated - is linked to a significantly increased risk of traffic accidents. In a recent umbrella review, where data from reviews and meta-analyses on 21.142.129 adults was assessed, a pooled prevalence of 3.1% of ADHD in adults was estimated. Considering that globally around 1.35 million people lose their lives and more than 50 million are suffering from injuries or disabilities due to road accidents, the fraction of car accidents caused by ADHD as a risk factor is considerable and needs to be addressed. This risk is largely presumed to be caused by an elevated level of inattentiveness in affected persons. Compounds of different groups, which can be classified in stimulants - formulations of methylphenidate and amphetamine - and non-stimulants - atomoxetin, guanfacine and clonidine -, have been shown to be effective in alleviating negative effects of ADHD, including inattentiveness. Under well-established but individually managed medication regimes, affected individuals can consequently lead a largely unirritated life and are not subject to fundamental restriction with respect to driving anymore. In children and adolescents, documented negative effects of stimulant medication include loss of appetite and decreased growth rates. It could however be shown that short-term interruptions (weekend, school holidays, and alike), introduced to alleviate aforementioned effects, do not affect the drug's beneficial effects in functional use (e.g., school). Such monitored medication breaks are often called drug holidays (D). They have become standard procedure in well-monitored treatment, predominantly including behavioral therapy. Based on own experience in childhood and or hearsay, also a fraction of affected adults under stimulant medication expresses the desire to take drug holidays and be themselves from time to time. With the predominant fraction of medication being fast acting drugs in extended-release formulation and typical patients being not only highly compliant but also extremely informed and adherent, these so-called drug holidays are reported an accepted in therapeutically accompanied settings of adults by now. However, while the overall positive effect of stimulant treatment on driving performance has been confirmed in a row of excellent on road- and/or simulation studies using integrated driving scores (IDS), so far there is no study available addressing the effect of drug holidays in adult drivers on driving performance. This represents a significant gap of evidence for both medical experts and affected. The proposed study will address this gap by exploring parameters of driving simulation in relation to drug holidays in ADHD patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Healthy Volunteers: f
View:

• adult drivers

• ADHD-diagnosed, established ADHD-treatment only with stimulants

• known history of drug holidays based on own decision,

• at impaired eyesight with more than +/- 5 diopter or astigmatism

• contact lenses are required (for eye tracking)

Locations
Other Locations
Switzerland
Division of Traffic Medicine, Institute of Forensic Medicine, University of Zurich,
RECRUITING
Zurich
Contact Information
Primary
Stefan Lakämper, Dr. rer. nat.
stefan.lakaemper@irm.uzh.ch
+41793789984
Backup
Nan Li, MSc
nan.li@irm.uzh.ch
+41797283245
Time Frame
Start Date: 2025-06-02
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 26
Treatments
Experimental: Group 1: M-M-D
stimulant-treated ADHD-affected participants will perform test sequence first in medicated state (M), then again in medicated state (M), then during drug holidays (D).
Experimental: Group 2: M-D-M
stimulant-treated ADHD-affected participants will perform test sequence first in medicated state (M), then during drug holidays (D), then again in medicated state (M).
Sponsors
Leads: Stefan Lakämper
Collaborators: Psychiatric University Hospital, Zurich, Swiss Federal Institute of Technology in Zurich (ETHZ)

This content was sourced from clinicaltrials.gov

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