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

NCT ID: NCT06910605

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-02
• Study Completion Date: 2026-10-31

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.

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity; Driving Simulator Performance; ADHD; Driving Behavior; Driving Ability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

"drug holidays" (D)

Intervention Type: DRUG

Participants omit three consecutive daily doses of ADHD-medication (stimulant).

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).

Group Type: EXPERIMENTAL

"drug holidays" (D)

Intervention Type: DRUG

Participants omit three consecutive daily doses of ADHD-medication (stimulant).

Interventions

"drug holidays" (D)

Participants omit three consecutive daily doses of ADHD-medication (stimulant).

Intervention Type: DRUG

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

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Psychiatric University Hospital, Zurich

OTHER

Sponsor Role: collaborator

Swiss Federal Institute of Technology in Zurich (ETHZ)

UNKNOWN

Sponsor Role: collaborator

Stefan Lakämper

OTHER

Sponsor Role: lead

Responsible Party

Stefan Lakämper

Dr. rer. nat. , Head Research & Research Development, Division of TRaffic Medicine, Institute for Forensic Medicine, University of Zurich

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stefan Lakämper, Dr. rer. nat.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Kristina Keller, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

Division of Traffic Medicine, Institute of Forensic Medicine, University of Zurich,

Zurich, ZRH, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Stefan Lakämper, Dr. rer. nat.

Role: CONTACT

stefan.lakaemper@irm.uzh.ch

+41793789984

Nan Li, MSc

Role: CONTACT

nan.li@irm.uzh.ch

+41797283245

Facility Contacts

Stefan Lakämper, Dr. rer. nat.

Role: primary

stefan.lakaemper@irm.uzh.ch

+41793789984

Nan Li, MSc

Role: backup

nan.li@irm.uzh.ch

Other Identifiers

DS-ADHD1

Identifier Type: -

Identifier Source: org_study_id