RecruitingPhase 2ACTRN12623001255673

The effects of alcohol on eye movement behaviour during driving

A randomised, placebo-controlled crossover trial examining the biphasic effects of alcohol on ocular parameters during driving in adults who drive regularly (ALC-GAZE)


Sponsor

Swinburne University of Technology

Enrollment

30 participants

Start Date

Jul 1, 2024

Study Type

Interventional

Conditions

Summary

This project investigates how low and moderate doses of alcohol affects eye movement patterns during driving. It will also examine how these doses of alcohol affects cognition, visual information processing, and subjective intoxication. It is hypothesised that eye tracking methods will show good sensitivity and reliability for detecting impairment due to alcohol usage during actual driving.


Eligibility

Sex: Both males and femalesMin Age: 21 YearssMax Age: 55 Yearss

Inclusion Criteria17

  • Male or female, aged 21 to 55 years
  • 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
  • Previous history of alcohol consumption in a single drinking session to an estimated BAC of 0.05% with no known adverse reaction [more than 3 standard drinks (female) or 4 standard drinks (male) on single drinking occasion]
  • Normal or corrected-to-normal vision
  • Regular driver (>50km/week) with three years of driving with a full Australian or International driver’s licence (no ‘P-Plate’ drivers)
  • Weight under 100kg. This limit is critical for participant safety. In this study, alcohol delivery is based on weight, and by defining this limit, we avoid overdosing and hence minimise potential health concerns
  • Willing to abstain from the following prior to their scheduled visit:
  • No food or drinks (except water) within 2 hours prior to testing
  • No caffeine-containing products within 12 hours prior to testing
  • No alcohol within 24 hours prior to testing
  • 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)
  • No illicit substance use for one week prior to, and for the duration of the trial.
  • No driving or riding a bicycle or motorbike to and from the testing site
  • No driving, riding, operating heavy machinery for 12 hours after leaving the site
  • No alcohol, illicit drugs, or medication (unless consulted with a doctor) for 12 hours after leaving the site.

Exclusion Criteria12

  • Unable to understand or comply with testing procedures
  • Inability to speak or read English
  • History of drug abuse or dependence or current illicit drug abuse
  • Current neurological, psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders
  • Pregnant or lactating
  • Taking any form of medication within one week of admission (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study
  • Unable to participate in scheduled visit, treatment plan, tests and other study procedures according to the protocol
  • Weight over 100kg
  • Moderate-severe current depression (BDI score of greater than or equal to 20)
  • Severe current anxiety (BAI score greater than or equal to 16)
  • Current participation in any other studies involving investigational or marketed products within 30 days prior to the screening visit;
  • Currently under administrative or legal supervision.

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Interventions

One dose (weighted and sex-dependent treatment) will be taken orally (by mouth) under supervised administration at each session [i.e. active treatment: weighted dose of alcohol (vodka) with orange jui

One dose (weighted and sex-dependent treatment) will be taken orally (by mouth) under supervised administration at each session [i.e. active treatment: weighted dose of alcohol (vodka) with orange juice to reach 0.05% Blood Alcohol Concentration (BAC); weighted dose of alcohol-free vodka with orange juice as the placebo treatment (control)]. The order of dosing will be randomised with a one-week washout period between testing sessions. The active treatment is a weighted and sex-specific dose of vodka and orange juice drink to achieve 0.05%BAC. This will be achieved using an adjustable calculation based on the Watson method of dosing per estimated total body water for men and women (derived from height and weight) rather than only body weight, as per the equation below: 1. Total Body Weight (TBW) men (Litres, L) = 2.2447 - (0.09516 x age) + (0.1074 x height) + (0.03362 x weight) 2. TBW women (L) = 2.097 - (0.1069 x height) + (0.2466 x weight) For an average 70 kg male person to achieve 0.05%BAC, this will require dosing of ~111g of 40% alcohol, or 4 standard drinks (30mL shots) with 334g mixer orange juice (total drink 445g). Participants are given 10 minutes to finish the drink, which is followed by a 10-minute absorption period Prior to dosing at each testing visit (each at V1 & V2), participants will provide one saliva sample to screen for evidence of recent use of drugs [amphetamine/d-methamphetamine, 3,4- methylenedioxymethamphetamine (MDMA), cocaine, cannabis (del ta-9-tetrahydrocannabinol) and opiates] using the Securetec DrugWipe 6s device. This screening assessment requires an absorbent pad to be placed over the tongue for approximately 20 seconds. 1ml of saliva will be taken per sample, therefore approximately 3ml in total over each of the three experimental sessions. A sample volume of less than 10 micro litres is sufficient for analysis. The device is wiped on the tongue, when the colour has changed from pink to yellow there is the required amount of saliva to obtain the results. The DRUID mobile app (Impairment Science, Inc.) will be used to assess the psychomotor and cognitive effect of the intervention. Four tasks will be used in this study to measure balance, reaction time, psychomotor vigilance, hand–eye coordination, attention to motion stimuli, and time estimation. Participants will be assessed at approximately 15 and 95 minutes post-dosing. The SRAVI app (Liopa) will be used to will be used to examine how alcohol consumption affects speech and to develop tools that can potentially identify different states of intoxication based on speech and lip movement patterns. Participants will complete the speech task before each driving test at 25 and 105 minutes post-dosing. A purpose-built mobile app will be used to collect data from participants during speech tasks during the speech task. Prior to the driving task, participants will communicate with the software via a dedicated Android phone mounted in a car (when the car is stationary only). Participants will be instructed to position their faces with the phone's camera and start the video by following the directions on the screen. The app will display a series of short phrases for the participants to read out loud and record video of lip movements as well as audio. Driving performance with simultaneous eye monitoring will be evaluated during on-road driving. Each participant will complete two seperate visits, corresponding to placebo and 0.05%BAC. Within each visit, participants will undergo four 15-minute driving tests to evaluate performance at baseline (pre-dosing), ascending (20 minutes post-dosing), peak (60 minutes post-dosing) and descending BAC levels (100 minutes post-dosing). These assessments will be conducted in an instrumented vehicle manufactured by Build Your Dreams (BYD Auto Co., Ltd., Shenzhen, China), equipped with automatic transmission and dual controls to allow for instructor intervention. Each 15-minute drive will follow the same pre-determined route around METEC Driver Training's closed-circuit course in Bayswater North. This highly controlled environment is closed to regular traffic and designed to include a combination of 40 and 60 km/h speed zones, along with a variety of road conditions and challenges to appropriately evaluate driving abilities and responsiveness. The hard-surfaced track is intended to mimic typical Australian road conditions, with gradual to sharp turns and a mix of single and dual lanes, each with a width of approximately 3 metres. It also features mid-line and side markings, as well as standard Australian road signage. The overall anticipated duration of each visit is 4 hours


Locations(1)

VIC, Australia

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ACTRN12623001255673


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