CompletedPhase 2ACTRN12623000528651

The effects of two doses of alcohol on eye movement behaviour during driving

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


Sponsor

Swinburne University of Technology

Enrollment

30 participants

Start Date

Jun 21, 2023

Study Type

Interventional

Conditions

Summary

This project investigates how low and moderate doses of alcohol affects eye movement patterns during simulated driving. It will also examine how these doses of alcohol affects cognition, visual information processing, and subjective intoxication


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 0.08% with no known adverse reaction [more than 5 standard drinks (female) or 6 standard drinks (male) on single drinking occasion]
  • Must have normal or corrected-to-normal vision
  • Is a 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
  • 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 12 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 12 hours after leaving the site
  • o No alcohol, illicit drugs, or medication (unless consulted with 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 (Beck Depression Inventory score of greater than or equal to 20)
  • Severe current anxiety (Beck Anxiety Inventory 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

Over the three-week experimental period, participants will receive all of the experimental doses. One dose (weighted and sex-dependent treatment) will be taken orally (by mouth) under supervised ad

Over the three-week experimental period, participants will receive all of the experimental doses. One dose (weighted and sex-dependent treatment) will be taken orally (by mouth) under supervised administration at each session [i.e. active treatment(s): weighted dose of alcohol (vodka) with orange juice to reach 0.05% Blood Alcohol Concentration (BAC); weighted dose of alcohol (vodka) with orange juice to reach 0.08% Blood Alcohol Concentration (BAC); or placebo treatment, weighted dose of alcohol-free vodka with orange juice] and the order of dosing will be randomised. The active treatments are: 1. Weighted and sex-specific dose of vodka and orange juice drink to achieve 0.05%BAC 2. Weighted and sex-specific dose of vodka orange juice drink to achieve 0.08%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). For 0.08%BAC, it will require ~175g of 40% alcohol, or ~5.7 standard drinks (30mL shots) with 527g mixer orange juice (total drink volume 703g). A one-week washout period will occur between testing sessions. Prior to dosing at each testing visit (each at V1, V2 and V3), 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. A registered research nurse trained in venepuncture or a qualified venepuncture technician will collect two blood samples at each testing session (each at V1-V3), at ~1 and ~2.5 hours post treatment administration. The Cambridge Neuropsychological Test Automated Battery (CANTAB) will be used to assess the cognitive effects of the intervention. Four tasks will be used in this study to assess such as fluid reasoning, executive function, attention, visual processing, short-term and long-term memory, processing speed and reaction/decision speed specifically: Multitasking Test, Spatial Working Memory, Rapid Visual Information Processing, Reaction Time and Spatial Span. Participants will be assessed at approximately 85 minutes post-dosing. Driving performance with simultaneous eye movement monitoring will be assessed using the Forum 8 driving simulator, and driving performance will be assessed three times per study session, for a 20 minute duration each. The simulator consists of a car unit with adjustable car seats and a dashboard and includes a steering wheel, turn sign indicators, gear lever, brake and accelerator pedals for vehicle control. The system generates realistic roadway scenery which is presented on three integrated TV screens 1.90 meters in front of the centre of the steering wheel. The speed and gear number are displayed on the dashboard and screen. Auditory feedback is provided by speakers and included the sound of the engine, braking, speeding in curves, and driving off-road. The simulation scenarios will incorporate features of a highway and suburban environment. Driving assessment will take place at baseline, at approximately 45 minutes and again at approximately 150 minutes post dosing. The overall anticipated duration of each visit is 3.5 hours


Locations(1)

VIC, Australia

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ACTRN12623000528651


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