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Trial registered on ANZCTR


Registration number
ACTRN12623000528651
Ethics application status
Approved
Date submitted
4/05/2023
Date registered
19/05/2023
Date last updated
28/07/2024
Date data sharing statement initially provided
19/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of two doses of alcohol on eye movement behaviour during driving
Scientific title
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).
Secondary ID [1] 309598 0
Nil
Universal Trial Number (UTN)
U1111-1292-1600
Trial acronym
ALC-GAZE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurological 329911 0
Condition category
Condition code
Neurological 326819 326819 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 326022 0
Treatment: Drugs
Comparator / control treatment
The placebo treatment is weighted alcohol-free vodka and orange juice drink (identical in taste, texture, weight and smell).
Control group
Placebo

Outcomes
Primary outcome [1] 334661 0
Associations between acute dose of alcohol (0.05%BAC; 0.08%BAC) and eye movement behaviour during driving.
Timepoint [1] 334661 0
After administration of treatment. Specifically, this will occur at baseline, 45 minutes and 150 minutes post dosing. This will be assessed using the PC-Driver Monitoring System (PC-DMS) eye monitoring system during the driving task using the Forum 8 driving simulator. Gaze behaviour, expressed as gaze transition entropy will be assessed.
Primary outcome [2] 334662 0
Associations between acute dose of alcohol (0.05%BAC; 0.08%BAC) and driving performance will be assessed.
Timepoint [2] 334662 0
After administration of treatment. Specifically, this will occur at baseline, 45 minutes and 150 minutes post dosing. This will be assessed using the PC-DMS eye monitoring system during the driving task using the Forum 8 driving simulator. Weaving of the car, expressed as standard deviation of the lateral position (SDLP), will be assessed.
Primary outcome [3] 334663 0
Associations between acute dose of alcohol (0.05%BAC; 0.08%BAC) and and eye movement behaviour during driving
Timepoint [3] 334663 0
After administration of treatment. Specifically, this will occur at baseline, 45 minutes and 150 minutes post dosing. This will be assessed using the PC-DMS eye monitoring system during the driving task using the Forum 8 driving simulator. Gaze behaviour, expressed as saccade (duration, amplitude), will be assessed.
Secondary outcome [1] 421571 0
Associations between acute dose of alcohol (0.05%BAC; 0.08%BAC) and cognitive performance (response latencies and errors -Multitasking Task)
Timepoint [1] 421571 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [2] 421572 0
Associations between acute dose of alcohol (0.05%BAC; 0.08%BAC) and cognitive performance (errors - Spatial Working Memory, SWM)
Timepoint [2] 421572 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [3] 421573 0
Associations between acute dose of alcohol (0.05%BAC; 0.08%BAC) and cognitive performance (strategy score - SWM)
Timepoint [3] 421573 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [4] 421574 0
Associations between acute dose of alcohol (0.05%BAC; 0.08%BAC) and cognitive performance (prime score - Rapid Visual Processing, RVP)
Timepoint [4] 421574 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [5] 421575 0
Associations between acute dose of alcohol (0.05%BAC; 0.08%BAC) and cognitive performance (reaction and movement time)
Timepoint [5] 421575 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [6] 421576 0
Associations between acute dose of alcohol (0.05%BAC; 0.08%BAC) and cognitive performance (errors- reaction time)
Timepoint [6] 421576 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [7] 421577 0
Associations between acute dose of alcohol (0.05%BAC; 0.08%BAC) and cognitive performance (span length (the longest sequence successfully recalled _Spatial Span, SSP)
Timepoint [7] 421577 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [8] 421578 0
Associations between acute dose of alcohol (0.05%BAC; 0.08%BAC) and cognitive performance (errors, SSP)
Timepoint [8] 421578 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [9] 421579 0
Associations between acute dose of alcohol (0.05%BAC; 0.08%BAC) and cognitive performance (number of attempts, SSP)
Timepoint [9] 421579 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [10] 421580 0
Associations between acute dose of alcohol (0.05%BAC; 0.08%BAC) and cognitive performance (latency (speed of response, SSP)
Timepoint [10] 421580 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [11] 421581 0
Associations between acute dose of alcohol (0.05%BAC; 0.08%BAC) and cognitive performance (overall task score - Driving Under the Influence of Drugs, DRUIDApp)
Timepoint [11] 421581 0
After administration of treatment. Specifically, this will occur at 30 minutes and 135 minutes hours post dosing. This will be assessed using the DRUID test battery.
Secondary outcome [12] 421582 0
Associations between acute dose of alcohol (0.05%BAC; 0.08%BAC) and eye movement behaviour during driving (PRIMARY OUTCOME)
Timepoint [12] 421582 0
After administration of treatment. Specifically, this will occur at baseline, 45 minutes and 150 minutes post dosing. This will be assessed using the PC-DMS eye monitoring system during the driving task using the Forum 8 driving simulator. Eye movement behaviour, expressed as fixation, will be assessed..
Secondary outcome [13] 421583 0
Associations between acute dose of alcohol (0.05%BAC; 0.08%BAC) and eye movement behaviour during driving (PRIMARY OUTCOME)
Timepoint [13] 421583 0
After administration of treatment. Specifically, this will occur at baseline, 45 minutes and 150 minutes post dosing. This will be assessed using the PC-DMS eye monitoring system during the driving task using the Forum 8 driving simulator. Eye movement behaviour, expressed as blink (amplitude, velocity, duration) will be assessed.
Secondary outcome [14] 421584 0
To identify the effect of acute dose of alcohol (0.05%BAC; 0.08%BAC) and driving performance (PRIMARY OUTCOME)
Timepoint [14] 421584 0
After administration of treatment. Specifically, this will occur at baseline, 45 minutes and 150 minutes post dosing. This will be assessed using the PC-DMS eye monitoring system during the driving task using the Forum 8 driving simulator. Headway, expressed as distance to front vehicle will be assessed
Secondary outcome [15] 421585 0
To identify the effect of acute dose of alcohol (0.05%BAC; 0.08%BAC) and driving performance (PRIMARY OUTCOME)
Timepoint [15] 421585 0
After administration of treatment. Specifically, this will occur at baseline, 45 minutes and 150 minutes post dosing. This will be assessed using the PC-DMS eye monitoring system during the driving task using the Forum 8 driving simulator. Reaction time, expressed as time to react to vehicles/pedestrians, will be assessed.
Secondary outcome [16] 421586 0
To identify the effect of acute dose of alcohol (0.05%BAC; 0.08%BAC) and subjective drug effects
Timepoint [16] 421586 0
After administration of treatment. Specifically, this will occur at approximately 20 minutes, 70 minutes 130 minutes and 175 minutes post dosing using a subjective questionnaire (B-BAES) designed to measure the biphasic stimulant (first phase) and sedative (second phase) effects of the alcohol. The B-BAES is a 6-item scale, measuring the degree to which participants feel Energised, Excited, Sedated, Slow Thoughts, Sluggish and Up. Participants respond on a 6-point Likert scale from 0 (Not at all) to 10 (Extremely).
Secondary outcome [17] 421587 0
To identify the effect of acute dose of alcohol (0.05%BAC; 0.08%BAC) on subjective sleepiness effects
Timepoint [17] 421587 0
At baseline (pre-dosing) and after administration of treatment. Specifically, post-dosing, this will occur at approximately 20 minutes, 70 minutes, 130 minutes and 175 minutes post dosing using a subjective questionnaire. Participants be asked to rate their levels of sleepiness using the Karolinska Sleepiness Scale. Participants are to indicate which response best reflects their psycho-physical state in the last 10 minutes. There are 9 levels of response, ranging from 1 (extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep).
Secondary outcome [18] 421588 0
To identify the effect of acute dose of alcohol (0.05%BAC; 0.08%BAC) on subjective driving ability
Timepoint [18] 421588 0
At baseline (pre-dosing) and after administration of treatment. Specifically, this will occur at 45 minutes and 150 minutes post dosing using a subjective questionnaire. Participants be asked to rate the perceived quality of their driving performance on the Perceived Driving Quality Scale; a visual analogue scale that ranges from 0 (I drove exceptionally poorly) to 20 (I drove exceptionally well) around a midpoint of I drove normally.
Secondary outcome [19] 421589 0
To identify the effect of acute dose of alcohol (0.05%BAC; 0.08%BAC) on mental load
Timepoint [19] 421589 0
After administration of treatment. Specifically, this will occur at approximately 70 minutes, and 175 minutes post dosing using a subjective questionnaire. Participants be asked to rate the perceived quality of effort using the NASA Task Load Index (TLX). Increments of high, medium, and low estimates for each point result in 21 gradations on the scales:
- Mental Demand
- Physical Demand
- Temporal Demand
- Performance
- Effort
- Frustration
Secondary outcome [20] 421590 0
To identify the effect of acute dose of alcohol (0.05%BAC; 0.08%BAC) on subjective intoxication
Timepoint [20] 421590 0
After administration of treatment. Specifically, this will occur at approximately 20 minutes, 70 minutes, 130 minutes and 175 minutes post dosing using a subjective questionnaire. Participants will be asked to rate their perceived level of intoxication with the question “Can you rate how intoxicated you feel right now on a scale of 0 to 10” (where 10 represents the highest level of intoxication)
Secondary outcome [21] 421591 0
To identify the effect of acute dose of alcohol (0.05%BAC; 0.08%BAC) on estimated BAC
Timepoint [21] 421591 0
After administration of treatment. Specifically, this will occur at approximately 20 minutes, 70 minutes, 130 minutes and 175 minutes post dosing using a subjective questionnaire. Participants will be asked to self-report their level of perceived intoxication (guess BAC, gBAC) at 5 time-points to measure how well participants can recognise the effects of alcohol. They will be asked the question: “What do you estimate is your current Blood Alcohol Content?”. If participants asked what particular BAC values corresponded to, research assistants gave the following answer: “Answers may range from 0.00 (which is sober) to 0.40 (which is the lethal limit), where .05% is the legal limit for intoxication while driving in the state of Victoria
Secondary outcome [22] 421592 0
To identify the effect of acute dose of alcohol (0.05%BAC; 0.08%BAC) and eye movement behaviour during driving (PRIMARY OUTCOME)
Timepoint [22] 421592 0
After administration of treatment. Specifically, this will occur at baseline, 45 minutes and 150 minutes post dosing. This will be assessed using the PC-DMS eye monitoring system during the driving task using the Forum 8 driving simulator. Gaze behaviour, expressed as stationary gaze entropy, will be assessed.
Secondary outcome [23] 421593 0
To identify the effect of acute dose of alcohol (0.05%BAC; 0.08%BAC) on estimated BAC confidence score
Timepoint [23] 421593 0
After administration of treatment. Specifically, this will occur at approximately 20 minutes, 70 minutes, 130 minutes and 175 minutes post dosing using a subjective questionnaire. Participants will be asked to self-report their confidence in their reported level of perceived intoxication. Participants will indicate their level of confidence in their answer (as defined above) using a 5-item scale. Items will range from 0 = not at all confident, to 5 = extremely confident
Secondary outcome [24] 421595 0
To identify the effect of acute dose of alcohol (0.05%BAC; 0.08%BAC) on Vestibulo-ocular reflex (VOR) (speed and magnitude of head and gaze motion)
Timepoint [24] 421595 0
After administration of treatment. Specifically, this will occur at baseline, 45 minutes and 150 minutes post dosing. This will be assessed using the PC-DMS eye monitoring system before the driving task. Vestibulo-ocular reflex, expressed as speed of head movement (ms), will be assessed.
Secondary outcome [25] 421597 0
To identify the effect of acute dose of alcohol (0.05%BAC; 0.08%BAC) on Optokinetic reflex (OKR) (speed and magnitude of head and gaze motion)
Timepoint [25] 421597 0
After administration of treatment. Specifically, this will occur at baseline, 45 minutes and 150 minutes post dosing. This will be assessed using the PC-DMS eye monitoring system before the driving task. Optokinetic reflex, expressed as speed of head movement (ms), will be assessed.
Secondary outcome [26] 421598 0
Identify associations between whole blood concentrations of alcohol and on stationary gaze entropy during driving.
Timepoint [26] 421598 0
After administration of treatment using cannulation procedure. Specifically, this will occur at approximately 45 minutes and 150 minutes post dosing and over the duration of the driving task as function of treatment.
Secondary outcome [27] 421599 0
Identify associations between whole blood concentrations of alcohol on blink (duration, frequency) during driving.
Timepoint [27] 421599 0
After administration of treatment using cannulation procedure. Specifically, this will occur at approximately 45 minutes and 150 minutes post dosing and over the duration of the driving task as function of treatment.
Secondary outcome [28] 421600 0
Identify associations between whole blood concentrations of alcohol on saccadic eye movement (duration, amplitude) during driving
Timepoint [28] 421600 0
After administration of treatment using cannulation procedure. Specifically, this will occur at approximately 45 minutes and 150 minutes post dosing and over the duration of the driving task as function of treatment.
Secondary outcome [29] 421601 0
Identify associations between whole blood concentrations of alcohol and cognitive performance (errors - Spatial Working Memory, SWM)
Timepoint [29] 421601 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [30] 421603 0
Identify associations between whole blood concentrations of alcohol and cognitive performance (strategy score - SWM)
Timepoint [30] 421603 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [31] 421604 0
Identify associations between whole blood concentrations of alcohol and cognitive performance (prime score - Rapid Visual Processing, RVP)
Timepoint [31] 421604 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [32] 421605 0
Identify associations between whole blood concentrations of alcohol and cognitive performance (response latencies and errors -Multitasking Task)
Timepoint [32] 421605 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [33] 421606 0
Identify associations between whole blood concentrations of alcohol and cognitive performance (reaction and movement time)
Timepoint [33] 421606 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [34] 421607 0
Identify associations between whole blood concentrations of alcohol and cognitive performance (errors- reaction time)
Timepoint [34] 421607 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [35] 421608 0
Identify associations between whole blood concentrations of alcohol and cognitive performance (span length (the longest sequence successfully recalled _Spatial Span, SSP)
Timepoint [35] 421608 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [36] 421609 0
Identify associations between whole blood concentrations of alcohol and cognitive performance (errors, SSP)
Timepoint [36] 421609 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [37] 421610 0
Identify associations between whole blood concentrations of alcohol and cognitive performance (number of attempts, SSP)
Timepoint [37] 421610 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [38] 421611 0
Identify associations between whole blood concentrations of alcohol and cognitive performance (latency (speed of response, SSP)
Timepoint [38] 421611 0
After administration of treatment. Specifically, this will occur at 85 minutes post dosing. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [39] 421612 0
Identify associations between whole blood concentrations of alcohol and cognitive performance (overall task score - Driving Under the Influence of Drugs, DRUIDApp)
Timepoint [39] 421612 0
After administration of treatment. Specifically, this will occur at 30 minutes and 135 minutes hours post dosing. This will be assessed using the DRUID test battery.

Eligibility
Key inclusion criteria
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.
Minimum age
21 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Blinding will be achieved by enlisting a disinterested third-party to code the treatments, and maintain the key to this code until data collection is completed.

The study treatments will be assigned in capital letters and the letter “A” to “C” to signify the blinded randomisation group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of the order of treatment visits will be determined by random allocation by a disinterested third party. All consenting participants will be assigned a participant number. The randomisation order that has been placed next to the participants’ number will be the allocated treatment order for that individual using publicly available randomisation software (Research Randomiser Software Version 4.0).

Randomisation codes will be kept in a locked file in a secure local server at Swinburne University of Technology. Although study investigators will know the location of, and have access to, the file, they will not access it during data collection and data screening procedures. Access will only occur in the case of an emergency when the participant’s allocated treatment needs to be known. If this occurs, the ethics committee will be informed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Baseline and placebo controlled
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographic data will be presented with summary statistics (number of participants, mean, standard deviation, median and range for variables) for each study. A fixed-effect Linear Mixed Model will be used to assess differences in subjective, neurocognitive and driving performance variables between the treatments (alcohol dose vs placebo) and across time (drive duration, examined in 10-minute bins) for each condition. Post hoc comparisons will be undertaken where significant condition or interaction effects are observed to determine the significance of differences as a function of time and treatment.

Correlations between biological sample data (blood concentrations of alcohol), subjective measures, cognitive outcomes, and performance on the driving outcomes across time and as function of treatment will be conducted using Pearson product moment coefficient r. The predictive ability of performance on cognitive outcome to performance on the driving task(s) will be assessed using linear regression models.
Raw data will be processed using R (RStudio, Inc., Boston, MA, USA) to calculate the ocular parameters. All statistical analyses will be conducted using SPSS (IBM Corp, Armonk, NY), and tests are two-tailed with a conventional level of significance of p< 0.05

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/05/2023
Actual
21/06/2023
Date of last participant enrolment
Anticipated
21/06/2025
Actual
Date of last data collection
Anticipated
21/07/2025
Actual
Sample size
Target
30
Accrual to date
17
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 313779 0
Commercial sector/Industry
Name [1] 313779 0
Seeing Machines
Country [1] 313779 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
427-451 Burwood Road
Hawthorn, Victoria, 3122
Country
Australia
Secondary sponsor category [1] 315614 0
None
Name [1] 315614 0
Address [1] 315614 0
Country [1] 315614 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312949 0
Swinburne University Human Research Ethics
Ethics committee address [1] 312949 0
Ethics committee country [1] 312949 0
Australia
Date submitted for ethics approval [1] 312949 0
02/03/2023
Approval date [1] 312949 0
03/05/2023
Ethics approval number [1] 312949 0
20237067-14201

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126446 0
Dr Amie Hayley
Address 126446 0
Swinburne University of Technology,
Centre for Mental Health and Brain Sciences
Mail H24
PO Box 218
Hawthorn, Victoria, 3122
Country 126446 0
Australia
Phone 126446 0
+61 3 92145585
Fax 126446 0
Email 126446 0
[email protected]
Contact person for public queries
Name 126447 0
Amie Hayley
Address 126447 0
Swinburne University of Technology,
Centre for Mental Health and Brain Sciences
Mail H24
PO Box 218
Hawthorn, Victoria, 3122
Country 126447 0
Australia
Phone 126447 0
+61 3 92145585
Fax 126447 0
Email 126447 0
[email protected]
Contact person for scientific queries
Name 126448 0
Amie Hayley
Address 126448 0
Swinburne University of Technology,
Centre for Mental Health and Brain Sciences
Mail H24
PO Box 218
Hawthorn, Victoria, 3122
Country 126448 0
Australia
Phone 126448 0
+61 3 92145585
Fax 126448 0
Email 126448 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to the sensitive nature of the data collected, we will not be making IPD available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.