Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001255673
Ethics application status
Approved
Date submitted
3/11/2023
Date registered
5/12/2023
Date last updated
29/08/2024
Date data sharing statement initially provided
5/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of alcohol on eye movement behaviour during driving
Scientific title
A randomised, placebo-controlled crossover trial examining the biphasic effects of alcohol on ocular parameters during driving in adults who drive regularly (ALC-GAZE)
Secondary ID [1] 310832 0
Nil
Universal Trial Number (UTN)
Trial acronym
ALC-GAZE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurological 331835 0
Neurological 332247 0
Condition category
Condition code
Eye 328575 328575 0 0
Normal eye development and function
Neurological 328962 328962 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 three 20-minute driving tests to evaluate performance at baseline (pre-dosing), ascending (30 minutes post-dosing) and descending BAC levels (110 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 20-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
Intervention code [1] 327244 0
Treatment: Drugs
Comparator / control treatment
Weights and sex-specific dose of alcohol-free vodka and orange juice drink (identical in taste, texture, weight and smell). The ratio of alcohol-free vodka and orange juice in the placebo drink will mirror that of the 0.05%BAC condition.
Control group
Placebo

Outcomes
Primary outcome [1] 336385 0
Associations between an acute dose of alcohol (0.05%BAC) and eye movement behaviour (gaze entropy - transition) during driving.
Timepoint [1] 336385 0
Baseline (pre-treatment), ascending (30 minutes post-treatment) and descending BAC levels (110 minutes post-treatment).
Primary outcome [2] 336467 0
Associations between an acute dose of alcohol (0.05%BAC) and eye movement behaviour (gaze entropy - stationary) during driving.
Timepoint [2] 336467 0
Baseline (pre-treatment), ascending (30 minutes post-treatment) and descending BAC levels (110 minutes post-treatment).
Primary outcome [3] 336468 0
Associations between an acute dose of alcohol (0.05%BAC) and driving performance, shown as weaving of the car, expressed as standard deviation of the lateral position (SDLP).
Timepoint [3] 336468 0
Baseline (pre-treatment), ascending (30 minutes post-treatment) and descending BAC levels (110 minutes post-treatment).
Secondary outcome [1] 428492 0
Associations between an acute dose of alcohol (0.05%BAC) and eye movement behaviour [percentage of total eye closure time (PERCLOS)] during driving.
Timepoint [1] 428492 0
Baseline (pre-treatment), ascending (30 minutes post-treatment) and descending BAC levels (110 minutes post-treatment).
Secondary outcome [2] 428493 0
Associations between an acute dose of alcohol (0.05%BAC) and eye movement behaviour (fixation location) during driving.
Timepoint [2] 428493 0
Baseline (pre-treatment), ascending (30 minutes post-treatment) and descending BAC levels (110 minutes post-treatment).
Secondary outcome [3] 428494 0
Associations between an acute dose of alcohol (0.05%BAC) and driving performance, measured using standard deviation of the steering wheel angle, representing steering variability.
Timepoint [3] 428494 0
Baseline (pre-treatment), ascending (30 minutes post-treatment) and descending BAC levels (110 minutes post-treatment).
Secondary outcome [4] 428495 0
Associations between an acute dose of alcohol (0.05%BAC) and driving performance, measured as standard deviation of speed (SDS).
Timepoint [4] 428495 0
Baseline (pre-treatment), ascending (30 minutes post-treatment) and descending BAC levels (110 minutes post-treatment).
Secondary outcome [5] 428496 0
Associations between an acute dose of alcohol (0.05%BAC) and driving performance, measured as number of lane deviations.
Timepoint [5] 428496 0
Baseline (pre-treatment), ascending (30 minutes post-treatment) and descending BAC levels (110 minutes post-treatment).
Secondary outcome [6] 428497 0
Associations between an acute dose of alcohol (0.05%BAC) and cognitive and psychomotor performance, measured as a composite score of balance, reaction time, psychomotor vigilance, hand–eye coordination, attention to motion stimuli, and time estimation
Timepoint [6] 428497 0
Ascending (15 minutes post-treatment) and descending BAC levels (95 minutes post-treatment).
Secondary outcome [7] 428498 0
Associations between an acute dose of alcohol (0.05%BAC) and speed of speech.
Timepoint [7] 428498 0
Ascending (25 minutes post-treatment) and descending BAC levels (105 minutes post-treatment).
Secondary outcome [8] 428499 0
Associations between an acute dose of alcohol (0.05%BAC) and subjective sleepiness.
Timepoint [8] 428499 0
Baseline (pre-treatment), ascending (10 minutes post-treatment) and descending BAC levels (90 minutes post-treatment).
Secondary outcome [9] 428510 0
The effect of an acute dose of alcohol (0.05%BAC) on self-perceived estimated blood alcohol content (BAC).
Timepoint [9] 428510 0
Ascending (10 and 60 minutes post-treatment) and descending BAC levels (105 and 135 minutes post-treatment).
Secondary outcome [10] 428511 0
The effect of an acute dose of alcohol (0.05%BAC) on self-perceived estimated blood alcohol content (BAC) confidence.
Timepoint [10] 428511 0
Ascending (10 and 60 minutes post-treatment) and descending BAC levels (105 and 135 minutes post-treatment).
Secondary outcome [11] 428522 0
To identify the effect of an acute dose of alcohol (0.05%BAC) and subjective drug effects.
Timepoint [11] 428522 0
Ascending (10 and 60 minutes post-treatment) and descending BAC levels (105 and 135 minutes post-treatment).
Secondary outcome [12] 428524 0
To identify the effect of an acute dose of alcohol (0.05%BAC) on mental load, measured using the NASA Task Load Index (NASA-TLX).
Timepoint [12] 428524 0
Ascending (60 minutes post-treatment) and descending BAC levels (135 minutes post-treatment).
Secondary outcome [13] 428526 0
The effect of acute dose of an alcohol (0.05%BAC) on subjective driving ability.
Timepoint [13] 428526 0
Ascending (60 minutes post-treatment) and descending BAC levels (135 minutes post-treatment).
Secondary outcome [14] 429196 0
Associations between an acute dose of alcohol (0.05%BAC) and eye movement behaviour (fixation duration) during driving.
Timepoint [14] 429196 0
Baseline (pre-treatment), ascending (30 minutes post-treatment) and descending BAC levels (110 minutes post-treatment).
Secondary outcome [15] 429198 0
Associations between an acute dose of alcohol (0.05%BAC) and eye movement behaviour (fixation count) during driving.
Timepoint [15] 429198 0
Baseline (pre-treatment), ascending (30 minutes post-treatment) and descending BAC levels (110 minutes post-treatment).
Secondary outcome [16] 429201 0
Associations between an acute dose of alcohol (0.05%BAC) and lip movement patterns.
Timepoint [16] 429201 0
Ascending (25 minutes post-treatment) and descending BAC levels (105 minutes post-treatment).

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 0.05% 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.
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 (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.

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)
For the purposes of this single-blind trial, the allocation of treatments will not be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A disinterested third party will employ publicly available randomisation software (Research Randomiser Software Version 4.0) to allocate a treatment code to each participant ID (e.g., 1, 2, 3). During the screening session, participants who provide consent will be assigned an ID, which corresponds to a specific treatment code for three sessions. Treatments will be designated by capital letters "A" or "B." The investigator will have access to the randomisation information throughout the duration of the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographic information will be presented with summary statistic (mean, standard deviation, median and range) for age, body mass index (kg/m²), and other related variables.

Raw data will undergo analysis using R (RStudio, Inc., Boston, MA, USA) to compute minute-by-minute driving and ocular performance indicators, as well as the overall means for the entire driving task. All subsequent statistical examinations will be carried out within SPSS (IBM Corp, Armonk, NY). Significance tests will be two-tailed, adhering to the conventional significance threshold of p < 0.05.

Linear fixed effects models will be used to examine the effect of treatment (placebo; 0.05%BAC) on target outcomes. Treatment will be entered into the model as a repeated measures factors and separate models were built with driving outcomes (standard deviation of lateral position, SDS, steering variability, and lane deviations), ocular parameters (SGE, GTE, and fixation duration and rate), and subjective drug effect scores (B-BAES, KSS and perceived driving quality) as the outcome variable. Where a main effect is observed, Bonferroni corrected-post hoc paired t-tests will be conducted to contrast each treatment from placebo. Linear regression models will also used to assess associations between (i) BAC, (ii) subjective drug effects (B-BAES, KSS and estimated BAC and perceived driving quality), and driving and ocular outcomes. Finally, logistic regression and receiver operating characteristic (ROC) curve analyses will be employed to assess the predictive power of individual ocular parameters in relation to the total number of lane departures for each minute of driving within each treatment condition.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
1/07/2024
Date of last participant enrolment
Anticipated
6/01/2025
Actual
Date of last data collection
Anticipated
3/02/2025
Actual
Sample size
Target
30
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315078 0
Commercial sector/Industry
Name [1] 315078 0
Seeing Machines
Country [1] 315078 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] 317097 0
None
Name [1] 317097 0
Address [1] 317097 0
Country [1] 317097 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314025 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 314025 0
Ethics committee country [1] 314025 0
Australia
Date submitted for ethics approval [1] 314025 0
22/09/2023
Approval date [1] 314025 0
16/10/2023
Ethics approval number [1] 314025 0
20237505-16787

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

Contacts
Principal investigator
Name 130162 0
Dr Amie Hayley
Address 130162 0
Swinburne University of Technology, Centre for Mental Health and Brain Sciences Mail H24 PO Box 218 Hawthorn, Victoria, 3122
Country 130162 0
Australia
Phone 130162 0
+61 3 92145585
Fax 130162 0
Email 130162 0
[email protected]
Contact person for public queries
Name 130163 0
Amie Hayley
Address 130163 0
Swinburne University of Technology, Centre for Mental Health and Brain Sciences Mail H24 PO Box 218 Hawthorn, Victoria, 3122
Country 130163 0
Australia
Phone 130163 0
+61 3 92145585
Fax 130163 0
Email 130163 0
[email protected]
Contact person for scientific queries
Name 130164 0
Amie Hayley
Address 130164 0
Swinburne University of Technology, Centre for Mental Health and Brain Sciences Mail H24 PO Box 218 Hawthorn, Victoria, 3122
Country 130164 0
Australia
Phone 130164 0
+61 3 92145585
Fax 130164 0
Email 130164 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.