NCT06910605 Exploring Parameters of Driving Simulation in Relation to Drug Holidays in ADHD Patients
| NCT ID | NCT06910605 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stefan Lakämper |
| Condition | ADHD - Attention Deficit Disorder With Hyperactivity |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2025-06-02 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 26 participants in total. It began in 2025-06-02 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion criteria: * 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) Exclusion criteria: * sensibility to motion sickness (kinetosis, dizziness etc. in 5 min screening drive) * non-stimulant-treatment * inability to understand the study procedure for linguistic or cognitive reasons * professional drivers (if working during the study period) * for women: pregnancy
Contact & Investigator
Stefan Lakämper, Dr. rer. nat.
PRINCIPAL INVESTIGATOR
University of Zurich
Frequently Asked Questions
Who can join the NCT06910605 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, studying ADHD - Attention Deficit Disorder With Hyperactivity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06910605 currently recruiting?
Yes, NCT06910605 is actively recruiting participants. Contact the research team at stefan.lakaemper@irm.uzh.ch for enrollment information.
Where is the NCT06910605 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT06910605 clinical trial?
NCT06910605 is sponsored by Stefan Lakämper. The principal investigator is Stefan Lakämper, Dr. rer. nat. at University of Zurich. The trial plans to enroll 26 participants.