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Trial registered on ANZCTR


Registration number
ACTRN12624001163594p
Ethics application status
Submitted, not yet approved
Date submitted
10/09/2024
Date registered
24/09/2024
Date last updated
24/09/2024
Date data sharing statement initially provided
24/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
An On-track Trial to Assess Driving from Alcohol
Scientific title
A Closed-Circuit Track Trial to Assess Risk, Impairment and Performance from Alcohol in Healthy Participants
Secondary ID [1] 312903 0
None
Universal Trial Number (UTN)
Trial acronym
ALC-TRACK
Linked study record
This study is a sub-arm (Arm 2) of a larger study (CAN-TRACK, ACTRN12624001118594) examining the effects of medical cannabis on real-world driving performance. Arm 2 will serve as a healthy control group comparator group.

Health condition
Health condition(s) or problem(s) studied:
Neurological 335059 0
Condition category
Condition code
Mental Health 331568 331568 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 331671 331671 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
THE ALC-TRACK trial is a closed-circuit track study designed to assess the effects of alcohol on driving performance, focusing on cognitive and behavioural outcomes among healthy participants. Driving performance will be assessed individually, at the same testing sites as medical cannabis study (CAN-TRACK - ACTRN12624001118594) at the Australian Automotive Research Centre (AARC) and Metropolitan Traffic Education Centre (METEC).

This randomised, double-blind, placebo-controlled trial will assess real-world driving performance in 24 healthy participants. Participants will undergo repeated driving assessments on four separate days. Specifically, participants will undergo 1 alcohol and 1 placebo session at each site (AARC and METEC) in a randomised crossover design. The study schedule is detailed below-

(0) Screening session:
Eligibility criteria assessed by a registered research nurse at Swinburne University of Technology. This screening session will last approximately 1-hour.

(1) Alcohol/placebo session at AARC.
A practice drive will be completed 15 minutes prior to baseline. Baseline driving performance will be assessed approximately 20-hours prior to administration of alcohol/placebo. This session will last approximately 2 hours and will occur on Day 1 (i.e., Monday).

(2) Alcohol/placebo session at AARC.
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose. This session will last approximately 5 hours and will occur on Day 2 (i.e., Tuesday).

(3) Alcohol/placebo session at METEC.
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose. This session will last approximately 5 hours and will occur on Day 3 (i.e., Wednesday).


(4) Alcohol/placebo session at METEC.
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose. This session will last approximately 5 hours and will occur on Day 4 (i.e., Thursday).

Driving performance tasks will include a distraction task, telemetry data collection, and driving instructor ratings, and will last approximately 25 minutes each. The entire study duration for each participant is approximately two weeks (inclusive of screening a week prior).

Alcohol sufficient to produce a BAC of 0.05% or a placebo (alcohol-free vodka and orange juice) will be administered orally, under the supervision of the researchers. The intervention will be delivered face-to-face, individually, at the same testing sites as Arm 1 (medical cannabis). The dosage will be precisely calculated using a weighted, sex-specific formula that adjusts for estimated total body water, as determined by the Watson method. This approach, which factors in height and weight rather than body weight alone, ensures an accurate dose tailored to each participant to achieve the target BAC of 0.05%, as detailed in 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)

E.g., 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).

Adherence to the intervention will be closely monitored, with researchers supervising the administration of alcohol/placebo during the study sessions. Participants will be given a 15-minute window to consume the allocated alcohol/placebo drink.
Intervention code [1] 329452 0
Behaviour
Comparator / control treatment
Participants will receive both placebo and alcohol according to a randomised crossover design.

Placebo will be administered as an equivalent dose of alcohol free vodka and orange juice based on the weighted calculation for the active (alcohol) dose.
Control group
Placebo

Outcomes
Primary outcome [1] 339325 0
AARC: Standard deviation of lateral position (SDLP)
Timepoint [1] 339325 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Primary outcome [2] 339326 0
Primary for METEC Only: Frequency of lane excursions during driving.
Timepoint [2] 339326 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [1] 439454 0
Steering variability (SV)
Timepoint [1] 439454 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose (peak impairment), and 1.5-hour post-dose.
Secondary outcome [2] 439455 0
Standard deviation of speed (SDS)
Timepoint [2] 439455 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [3] 439456 0
Secondary for AARC Only: Frequency of lane excursions during driving.
Timepoint [3] 439456 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [4] 439457 0
Drive terminations during driving.
Timepoint [4] 439457 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [5] 439458 0
Adherence to instructed speeds during driving.
Timepoint [5] 439458 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [6] 439459 0
Assessor-rated driving performance.
Timepoint [6] 439459 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [7] 439460 0
Vehicle Telemetry Acceleration.
Timepoint [7] 439460 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [8] 439461 0
Vehicle Telemetry Braking.
Timepoint [8] 439461 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [9] 439462 0
Vehicle Telemetry Speeding.
Timepoint [9] 439462 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [10] 439463 0
Gaze transition entropy (GTE)
Timepoint [10] 439463 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [11] 439464 0
Stationary Gaze Entropy (SGE)
Timepoint [11] 439464 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [12] 439465 0
Long Glance Away (LGA) events
Timepoint [12] 439465 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [13] 439466 0
Visual Attention Time Sharing (VATS) Events
Timepoint [13] 439466 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [14] 439467 0
Blink Rate
Timepoint [14] 439467 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [15] 439468 0
Blink Duration
Timepoint [15] 439468 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [16] 439469 0
Fixation Rate
Timepoint [16] 439469 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [17] 439470 0
Fixation Duration
Timepoint [17] 439470 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [18] 439471 0
Eye Closure (Percent of Time Spent with Eyes Closed)
Timepoint [18] 439471 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [19] 439472 0
Microsleeps
Timepoint [19] 439472 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [20] 439473 0
Detection Response Task (DRT)
Timepoint [20] 439473 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [21] 439474 0
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Timepoint [21] 439474 0
Assessed following each driving session at baseline (pre-dose), at 1-hour post-dose, and 2-hours post-dose.
Secondary outcome [22] 439475 0
NASA Task Load Index (NASA-TLX)
Timepoint [22] 439475 0
Assessed following each driving session at baseline (pre-dose), at 1-hour post-dose, and 2-hours post-dose.
Secondary outcome [23] 439476 0
Subjective Driving Ability
Timepoint [23] 439476 0
Assessed following each driving session at baseline (pre-dose), at 1-hour post-dose, and 2-hours post-dose.
Secondary outcome [24] 439477 0
Breath Alcohol Concentration (BAC)
Timepoint [24] 439477 0
Assessed at baseline (pre-dose), to track BAC after dosing (up to 3 times), at 15-minutes post-dost, at 50 minutes post dose, at 1 hour 20-minutes post dose, at 2 hours post dose, at 2 hours 35 minutes post-dose, at 3 hours 10 minutes post-dose
Secondary outcome [25] 439478 0
Percent Road Centre (PRC)
Timepoint [25] 439478 0
Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.
Secondary outcome [26] 439479 0
Karolinska Sleepiness Scale (KSS)
Timepoint [26] 439479 0
Assessed following each driving session at baseline (pre-dose), at 1-hour post-dose, and 2-hours post-dose.
Secondary outcome [27] 439480 0
Biphasic Alcohol Effects Scale (B-BAES)
Timepoint [27] 439480 0
Assessed following each driving session at baseline (pre-dose), at 1-hour post-dose, and 2-hours post-dose.
Secondary outcome [28] 439486 0
Pupillary unrest index (PUI)
Timepoint [28] 439486 0
Assessed following each driving session at baseline (pre-dose), at 1-hour post-dose, and 2-hours post-dose.
Secondary outcome [29] 439487 0
Pupillary light reflex (PLR)
Timepoint [29] 439487 0
Assessed following each driving session at baseline (pre-dose), at 1-hour post-dose, and 2-hours post-dose.

Eligibility
Key inclusion criteria
-History of alcohol consumption in a single drinking session to an estimated BAC of 0.05% without adverse reaction (more than 2 standard drinks for females or 3 standard drinks for males in a single session).
-Weigh less than 100 kg.
-Possess a current and unrestricted Victorian driver’s licence.
-Oral fluid negative for all illicit drugs on the morning of test sessions
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Use of cannabis more than once per week.
-An AUDIT-C score greater than 12, indicating problematic drinking.
-Use of any psychoactive medication that could impact driving.
-Current diagnosis of any Axis 1 mental health or substance use disorder.
-Taking any form of medication within one week of admission (except for certain routine medications like prophylactic antibiotics or contraceptive pills).
-Moderate to severe current depression (BDI score of >=20).
-Severe current anxiety (BAI score of >=16).
-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)
Allocation will involve contacting the holder of the allocation schedule who will be "off-site" at Swinburne University of Technology (rather than at METEC/AARC).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
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
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
A sample size of n=24 allows researchers to detect a medium effect size (f=0.25) with 90% power assuming one group, 12 repeated measurements (12 drives over 4 days of testing), an estimated correlation among repeated measures of 0.5 and a conservative non-sphericity correction of 0.6. This effect size (f=0.25) is equivalent to the level of impairment that can be considered meaningful as defined in a recent meta-analysis of 80 publications comprising 1,534 driving or cognitive performance outcomes.

Statistical Analysis:
Demographic information will be presented with summary statistic (mean, median, standard deviation, percentage and range) for age, sex, body mass index (kg/m2), and other related variables. Linear mixed effects models will assess the main effect of time on target outcomes with both time and treatment (placebo/alcohol) as fixed factors.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/10/2024
Actual
Date of last participant enrolment
Anticipated
6/04/2026
Actual
Date of last data collection
Anticipated
24/04/2026
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317337 0
Government body
Name [1] 317337 0
Department of Transport and Planning (DTP)
Country [1] 317337 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Country
Australia
Secondary sponsor category [1] 319620 0
None
Name [1] 319620 0
Address [1] 319620 0
Country [1] 319620 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316067 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 316067 0
Ethics committee country [1] 316067 0
Australia
Date submitted for ethics approval [1] 316067 0
02/08/2024
Approval date [1] 316067 0
Ethics approval number [1] 316067 0

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

Contacts
Principal investigator
Name 136670 0
Prof Luke Downey
Address 136670 0
Advanced Technologies Centre, 427-451 Burwood Road, Hawthorn VIC 3122
Country 136670 0
Australia
Phone 136670 0
+61 03 9214 5781
Fax 136670 0
Email 136670 0
ldowney@swin.edu.au
Contact person for public queries
Name 136671 0
Dr Thomas Arkell
Address 136671 0
Advanced Technologies Centre, 427-451 Burwood Road, Hawthorn VIC 3122
Country 136671 0
Australia
Phone 136671 0
+61 03 9214 3571
Fax 136671 0
Email 136671 0
tarkell@swin.edu.au
Contact person for scientific queries
Name 136672 0
Dr Amie Hayley
Address 136672 0
Advanced Technologies Centre, 427-451 Burwood Road, Hawthorn VIC 3122
Country 136672 0
Australia
Phone 136672 0
+61 03 9214 5585
Fax 136672 0
Email 136672 0
ahayley@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.