The effect of an acute Methylphenidate (Ritalin®) dose on cognition, behaviour and driving performance in healthy volunteers

Phase 2

Recruiting

• Conditions: Attention deficits; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12620000499987
• Lead Sponsor: Swinburne University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-21
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Male or female, aged 21 to 45 years;
• Less than 100kg in weight [due to expected metabolism rate of Methylphenidate (Ritalin®), 10mg];
• Willing and able to provide written informed consent;
• Understands and is willing and able to comply with all study procedures;
• Fluent in written and spoken English;
• Must have normal or corrected-to-normal vision;
• Is a regular driver (> 4,000 km/year) with three years of driving with a full driver’s licence;
• Willing to abstain from the following prior to their scheduled visit:
o No food or drinks (except water) within 2 hours prior to testing;
o No caffeine-containing products within 12 hours prior to testing;
o No alcohol within 24 hours prior to testing;
o No medication for at least 1 week prior to testing (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne);
o No illicit substance use for one week prior to, and for the duration of the trial.
o No driving or riding a bicycle or motorbike from the testing site;
o No driving, riding, operating heavy machinery for 24 hours after leaving the site
o No alcohol, drugs, or medication (unless consulted with doctor) for 24 hours after
leaving the site.

Exclusion Criteria

• Unable to understand or comply with testing procedures;
• Inability to speak or read English;
• History of drug or substance abuse or current illicit drug abuse;
• History of neurological conditions or previous or current history of psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders;
• Pregnant, potentially pregnant or lactating;
• Taking any form of ongoing medication (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne);
• Unable to participate in scheduled visit, treatment plan, tests and other study procedures according to the protocol;
• Current participation in any other studies involving investigational or marketed products within 30 days prior to the screening visit;
• Have previously participated in this study
• Currently under administrative or legal supervision.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the efficacy of co-monitoring eye movement activity to identify driving impairment caused by consumption of Methylphenidate (Ritalin)[After administration of treatment. Specifically, this will occur at approximately 1.5 hours post dosing in conjunction with the driving simulator task. This will be assessed using the Sensometrics cap-mounted eye tracking system and will measure saccade];Associations between Methylpheniate (Ritalin) and cognitive performance (Digit Vigilance)[After administration of treatment. Specifically, this will occur at 30 minutes post-dosing and at 2.5 hours post dosing. This will be assessed using the CogTrack online test battery.];Associations between acute dose of Methylphenidate (Ritalin) 10mg and driving performance[After administration of treatment. Specifically, this will occur at ~2 hours post dosing. This will be assessed using the Forum 8 driving simulator. Weaving of the car, expressed as standard deviation of the lateral position (SDLP) will be assessed.]