Actively Recruiting

Phase Not Applicable
Age: 10Years +
All Genders
ID06910605

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

Led by Stefan Lakämper · Updated on 2025-06-05

26

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

S

Stefan Lakämper

Lead Sponsor

P

Psychiatric University Hospital, Zurich

Collaborating Sponsor

AI-Summary

What this Trial Is About

Attention Deficit Hyperactivity Disorder (ADHD) is associated with an increased risk of traffic accidents due to inattentiveness. This trial focuses on adult drivers with ADHD who are treated with stimulant medications and often take planned breaks from their medication, called "drug holidays." The study aims to explore how these medication breaks affect driving performance, addressing a significant gap in current research. Participants in this interventional trial will be randomly assigned to one of two groups. Both groups will undergo driving simulation tests while medicated and during a drug holiday, which involves skipping three consecutive doses of stimulant medication. The groups differ in the sequence of testing: one group tests medicated twice before the drug holiday, while the other alternates between medicated and drug holiday states. This design allows comparison of driving performance under both conditions. During the study, participants will complete driving simulation assessments at various time points, including during medication and drug holiday phases. Eye tracking will be used, requiring participants to wear contact lenses if needed. The main outcome measured is the difference in integrated driving scores (IDS) between medicated and drug holiday states over several days. Safety and participant ability to follow the study procedures will be monitored throughout the trial.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 10Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult drivers
  • Diagnosed with ADHD and treated only with stimulant medications
  • History of taking drug holidays based on own decision
  • Impaired eyesight greater than +/- 5 diopters or astigmatism
  • Use of contact lenses required for eye tracking
Not Eligible

You will not qualify if you...

  • Sensitivity to motion sickness, dizziness, or similar symptoms within 5 minutes of driving
  • Treatment with non-stimulant medications
  • Inability to understand the study procedures due to language or cognitive reasons
  • Professional drivers actively working during the study period
  • Pregnant women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Variable based on test sequences with at least 4 days between conditions

Participants undergo sequences of medicated states and "drug holidays" by omitting three consecutive daily doses of ADHD medication to assess driving simulation performance.

3 visits corresponding to each testing condition

Trial Site Locations

Total: 1 location

1

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

Zurich, ZRH, Switzerland, 8050

Actively Recruiting

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Research Team

S

Stefan Lakämper, Dr. rer. nat.

N

Nan Li, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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