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

NCT06910605 | Recruiting

• 1 other identifier: DS-ADHD1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Keywords

driving simulation; driving performance; eye tracking; EEG-recording; stimulant treatment; drug holidays

Outcome Measures

Primary Outcomes (1)

• Significant differences in IDS between conditions D and M

  Primary outcome parameter IDS (Integrated Driving Score) will be calculated by summation of z-scores of typical driving parameters such as, for example, the standard deviation of lane position (SDLP), standard deviation of velocity (SDS) or number of inappropriate lane departures, ILD. IDS will be measured on day 0 (= baseline, Visit 1), on day x (with x≥4, Visit 2) and on day x+3 (Visit 3).

  0, x, x+3 days, with x≥ 4 days

Study Arms (2)

Group 1: M-M-D

EXPERIMENTAL

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).

Drug: "drug holidays" (D)

Group 2: M-D-M

EXPERIMENTAL

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).

Drug: "drug holidays" (D)

Interventions

"drug holidays" (D) DRUG

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

Group 1: M-M-D; Group 2: M-D-M

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stefan Lakämper: lead
• Psychiatric University Hospital, Zurich: collaborator
• Swiss Federal Institute of Technology in Zurich (ETHZ): collaborator

Study Sites (1)

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

Zurich, ZRH, 8050, Switzerland

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Treatment Interruption; Fumigant 93

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Treatment Adherence and Compliance; Attitude to Health; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Stefan Lakämper, Dr. rer. nat.

  University of Zurich

  PRINCIPAL INVESTIGATOR

• Kristina Keller, Dr. med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Lakämper, Dr. rer. nat.

CONTACT

+41793789984; stefan.lakaemper@irm.uzh.ch

Nan Li, MSc

CONTACT

+41797283245; nan.li@irm.uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. rer. nat. , Head Research & Research Development, Division of TRaffic Medicine, Institute for Forensic Medicine, University of Zurich

Model Details: monocentric, within-subjects, observer-blinded cross-over trial (within-subject randomized crossover trial

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: April 4, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: starting after publication of study protcol and/or results
• Access Criteria: upon request by mail

Locations

CH (1)