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Trial registered on ANZCTR


Registration number
ACTRN12623000191695p
Ethics application status
Not yet submitted
Date submitted
2/02/2023
Date registered
23/02/2023
Date last updated
23/02/2023
Date data sharing statement initially provided
23/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Characterising gaze patterns during driving among people who use methamphetamine
Scientific title
A pilot study to characterise gaze patterns during driving among people who use methamphetamine versus people who have not used methamphetamine
Secondary ID [1] 308886 0
Nil
Universal Trial Number (UTN)
U1111-1287-7991
Trial acronym
Meth-gaze
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Substance use 328880 0
Condition category
Condition code
Injuries and Accidents 325874 325874 0 0
Other injuries and accidents
Mental Health 326018 326018 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will examine eye movement patterns during driving among individuals aged 21 to 60 years of age with physician-diagnosed methamphetamine dependence disorder and who currently use methamphetamine. Participants will first complete a pre-screening survey, and will then be invited to attend Swinburne University of Technology to complete a single session of testing, that will run for approximately 4 hours in duration. Eye tracking will take place simultaneously during the driving tasks, using a dash-mounted eye-tracking camera device. The device will not interfere with the driving tasks, and participants do not need to interact with it. All testing will be overseen by the research team, which includes a Research Assistant, Study Doctor and Research Nurse.
Intervention code [1] 325333 0
Not applicable
Comparator / control treatment
Healthy adults aged 21 to 60 years of age who have not used stimulant drugs and have no history of chronic/binge use of psychoactive substances.
Control group
Active

Outcomes
Primary outcome [1] 333712 0
Differences between the two groups on eye movement behaviour during driving
Timepoint [1] 333712 0
Specifically, this will occur at 60 minutes and 175 minutes of the testing session. 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 gaze transition entropy will be assessed.
Primary outcome [2] 333713 0
Differences between the groups on driving performance
Timepoint [2] 333713 0
Specifically, this will occur at 60 minutes and 175 minutes of the testing session. This will be assessed using the the Forum 8 driving simulator. Weaving of the car, expressed as standard deviation of the lateral position (SDLP), will be assessed.
Primary outcome [3] 333714 0
Differences between the two groups on eye movement behaviour during driving
Timepoint [3] 333714 0
Specifically, this will occur at 60 minutes and 175 minutes of the testing session. This will be assessed using the the Forum 8 driving simulator. 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] 418002 0
Differences between the two groups on eye movement behaviour during Visuospatial Working Memory (VSWM) task
Timepoint [1] 418002 0
Specifically, this will occur at 90 minutes of the testing session. This will be assessed using the EyeLink eye monitoring system during the VSWM task. Eye movement behaviour, expressed as saccades (amplitude, velocity, duration) will be assessed.
Secondary outcome [2] 418003 0
Differences between the two groups on cognitive performance (reaction and movement time)
Timepoint [2] 418003 0
This will occur at 10 minutes and at 130 minutes of the testing session. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [3] 418004 0
Differences between the two groups on cognitive performance (memory score)
Timepoint [3] 418004 0
This will occur at 10 minutes and at 130 minutes of the testing session. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [4] 418005 0
Differences between the two groups on cognitive performance (target sensitivity)
Timepoint [4] 418005 0
This will occur at 10 minutes and at 130 minutes of the testing session. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [5] 418006 0
Differences between the two groups on cognitive performance (Spatial Working Memory strategy score)
Timepoint [5] 418006 0
This will occur at 10 minutes and at 130 minutes of the testing session. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [6] 418007 0
Differences between the two groups on cognitive performance (Spatial Working Memory errors)
Timepoint [6] 418007 0
This will occur at 10 minutes and at 130 minutes of the testing session. This will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) online test battery.
Secondary outcome [7] 418008 0
Differences between the two groups on cognitive performance (overall task score - Driving Under the Influence of Drugs, DRUIDApp).
Timepoint [7] 418008 0
Specifically, this will occur at 80 minutes and 195 minutes of the testing session. This will be assessed using the DRUID test battery.
Secondary outcome [8] 418009 0
Differences between the two groups on eye movement behaviour during driving (PRIMARY OUTCOME)
Timepoint [8] 418009 0
Specifically, this will occur at 60 minutes and 175 minutes of the testing session. 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 [9] 418010 0
Differences between the two groups on eye movement behaviour during driving (PRIMARY OUTCOME)
Timepoint [9] 418010 0
Specifically, this will occur at 60 minutes and 175 minutes of the testing session. Specifically, this will occur at 60 minutes and 175 minutes of the testing session. 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 [10] 418011 0
Differences between the two groups on driving (PRIMARY OUTCOME)
Timepoint [10] 418011 0
Specifically, this will occur at 60 minutes and 175 minutes of the testing session. Specifically, this will occur at 60 minutes and 175 minutes of the testing session. This will be assessed using the Forum 8 driving simulator. This will be assessed using the Forum 8 driving simulator. Headway, expressed as distance to front vehicle will be assessed
Secondary outcome [11] 418012 0
Differences between the two groups on driving (PRIMARY OUTCOME)
Timepoint [11] 418012 0
Specifically, this will occur at 60 minutes and 175 minutes of the testing session. Specifically, this will occur at 60 minutes and 175 minutes of the testing session. This will be assessed using the Forum 8 driving simulator. This will be assessed using the Forum 8 driving simulator. Reaction time, expressed as time to react to front vehicle, will be assessed
Secondary outcome [12] 418013 0
Differences between the two groups on driving (PRIMARY OUTCOME)
Timepoint [12] 418013 0
Specifically, this will occur at 60 minutes and 175 minutes of the testing session. Specifically, this will occur at 60 minutes and 175 minutes of the testing session. This will be assessed using the Forum 8 driving simulator. This will be assessed using the Forum 8 driving simulator.. Reaction time, expressed as time to respond during the go-no-go task, will be assessed
Secondary outcome [13] 418014 0
To identify the differences between the two groups on driving on subjective driving ability
Timepoint [13] 418014 0
This will occur at approximately 5 minutes, 50 minutes and 85 minutes, 170 and 200 minutes of the study session 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 [14] 418015 0
To identify the differences between the two groups on subjective on mental load
Timepoint [14] 418015 0
This will occur at approximately 50 minutes, 85 minutes, 170 and 200 minutes of the study session 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 [15] 418016 0
To identify the differences between the two groups on state anxiety
Timepoint [15] 418016 0
This will occur at approximately 5 minutes, 85 minutes and 200 minutes of the study session using a subjective questionnaire. Participants be asked to rate the perceived anxiety levels on the State-Trait Anxiety Inventory (STAI). There are 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: “I am tense; I am worried” and “I feel calm; I feel secure.” Trait anxiety items include: “I worry too much over something that really doesn’t matter” and “I am content; I am a steady person.” All items are rated on a 4-point scale (e.g., from “Almost Never” to “Almost Always”).
Secondary outcome [16] 418017 0
To identify the differences between the two groups on subjective aggression
Timepoint [16] 418017 0
This will occur at approximately 5 minutes, 85 minutes and 200 minutes of the study session using a subjective questionnaire. Participants be asked to rate the perceived anxiety levels on the State-Trait Anger Expression Inventory–2 (STAXI-2). The STAXI-2 consists of 2 sub-scales (State and Trait Aggression), and an Anger Expression Index that provides an overall measure of total anger expression
Secondary outcome [17] 418018 0
Differences between the two groups on eye movement behaviour during driving (PRIMARY OUTCOME)
Timepoint [17] 418018 0
Specifically, this will occur at 60 minutes and 175 minutes of the testing session. 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 stationary gaze entropy, will be assessed.
Secondary outcome [18] 418020 0
Differences between the two groups on driving (PRIMARY OUTCOME)
Timepoint [18] 418020 0
Specifically, this will occur at 60 minutes and 175 minutes of the testing session. This will be assessed using the Forum 8 driving simulator. Psychomotor speed, expressed as reaction time (ms) will be assessed
Secondary outcome [19] 418022 0
Differences between the two groups on eye movement behaviour during Visuospatial Working Memory (VSWM) task
Timepoint [19] 418022 0
At approximately 90 minutes of the testing session. This will be assessed using the EyeLink eye monitoring system during the VSWM task. Eye movement behaviour, expressed as blink activity (amplitude, velocity, duration) will be assessed.
Secondary outcome [20] 418023 0
Differences between the two groups on eye movement behaviour during Visuospatial Working Memory (VSWM) task
Timepoint [20] 418023 0
At approximately 90 minutes of the testing session. This will be assessed using the EyeLink eye monitoring system during the VSWM task. Eye movement behaviour, expressed as fixations (duration, number) will be assessed
Secondary outcome [21] 418024 0
Identify plasma blood concentrations of methamphetamine among people who use methamphetamine
Timepoint [21] 418024 0
Using venupuncture procedure. Specifically, this will occur at approximately 55 minutes and 205 minutes of the testing session.

Eligibility
Key inclusion criteria
1. Healthy Controls
• Male and female participants aged 21-60 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.
• Normal vision or corrected with contact lenses.
• Currently hold a (full) drivers’ licence (no ‘P-platers’) and are active drivers (at least once/week), with at least three years of driving experience.
• No history of use of illicit amphetamine substances [amphetamine, methamphetamine, methylenedioxymethamphetamine (MDMA)]
• No use of other illicit substances or recreational (off-target) use of prescription medication either in past 12 months
• Absence of lifetime chronic/binge drug use (self-report)
• MMSE score greater than or equal to 23 (normal cognitive function)
• Willing to abstain from the following prior to their scheduled visit:
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.


2. People who use methamphetamine
• Male and female participants aged 21-60 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.
• Normal vision or corrected with contact lenses.
• Currently hold a (full) drivers’ licence (no ‘P-platers’) and are active drivers (at least once/week), with at least three years of driving experience.
• Self-reported current, ongoing use of methamphetamine (greater than or equal to 1/week for the past 6 weeks)
• Mini Mental State Exam (MMSE) score greater than or equal to 23 (normal cognitive function)
• Physician diagnosed current methamphetamine dependence (DSM-5 or equivalent)
• Does not meet other DSM substance-use criteria concurrently, except for nicotine or cannabis dependence (physician-confirmed).
• Willing to abstain from the following prior to their scheduled visit:
o No methamphetamine for 12 hours prior to testing (self-report)
o No alcohol within 12 hours prior to testing
Minimum age
21 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Healthy Controls
• Unable to understand or comply with testing procedures.
• Inability to speak or read English.
• 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.
• Currently under administrative or legal supervision.

2. People who use methamphetamine
• Unable to understand or comply with testing procedures.
• Inability to speak or read English.
• Unable to participate in scheduled visit, treatment plan, tests and other study procedures according to the protocol (e.g., unable to abstain from methamphetamine for 12 hours prior to study session).
• Currently under administrative or legal supervision.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Participants will be a total 30 adults aged between 18 - 60 years. As this is a pilot trial, an a-priori power analysis has not been conducted.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23902 0
Eastern Health - Box Hill
Recruitment hospital [2] 23903 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [3] 23904 0
Swinburne University of Technology - Hawthorn
Recruitment postcode(s) [1] 39386 0
3128 - Box Hill
Recruitment postcode(s) [2] 39387 0
3065 - Fitzroy
Recruitment postcode(s) [3] 39388 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 313101 0
University
Name [1] 313101 0
Swinburne University of Technology
Country [1] 313101 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] 314802 0
None
Name [1] 314802 0
None
Address [1] 314802 0
Country [1] 314802 0
Other collaborator category [1] 282537 0
Hospital
Name [1] 282537 0
Turning Point Eastern Treatment Services
Address [1] 282537 0
Ground Floor/43 Carrington Rd, Box Hill VIC 3128
Country [1] 282537 0
Australia
Other collaborator category [2] 282540 0
Hospital
Name [2] 282540 0
Addiciton Medicine at St Vincent's Hospital
Address [2] 282540 0
62 Gertrude Street,
Fitzroy, VIC 3065
Country [2] 282540 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 312348 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 312348 0
Ethics committee country [1] 312348 0
Australia
Date submitted for ethics approval [1] 312348 0
03/03/2023
Approval date [1] 312348 0
Ethics approval number [1] 312348 0
Ethics committee name [2] 312351 0
Eastern Health Human Research Ethics Committee
Ethics committee address [2] 312351 0
Ethics committee country [2] 312351 0
Australia
Date submitted for ethics approval [2] 312351 0
24/03/2023
Approval date [2] 312351 0
Ethics approval number [2] 312351 0
Ethics committee name [3] 312352 0
St Vincent's Hospital Melbourne Human Research Ethics Committee (HREC)
Ethics committee address [3] 312352 0
Ethics committee country [3] 312352 0
Australia
Date submitted for ethics approval [3] 312352 0
24/03/2023
Approval date [3] 312352 0
Ethics approval number [3] 312352 0

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

Contacts
Principal investigator
Name 124338 0
Dr Amie Hayley
Address 124338 0
Swinburne University of Technology,
School of Health Sciences
Centre for Mental Health and Brain Sciences
Mail H24
PO Box 218
Hawthorn, Victoria, 3122
Country 124338 0
Australia
Phone 124338 0
+61392145585
Fax 124338 0
Email 124338 0
ahayley@swin.edu.au
Contact person for public queries
Name 124339 0
Amie Hayley
Address 124339 0
Swinburne University of Technology,
School of Health Sciences
Centre for Mental Health and Brain Sciences
Mail H24
PO Box 218
Hawthorn, Victoria, 3122
Country 124339 0
Australia
Phone 124339 0
+61392145585
Fax 124339 0
Email 124339 0
ahayley@swin.edu.au
Contact person for scientific queries
Name 124340 0
Amie Hayley
Address 124340 0
Swinburne University of Technology,
School of Health Sciences
Centre for Mental Health and Brain Sciences
Mail H24
PO Box 218
Hawthorn, Victoria, 3122
Country 124340 0
Australia
Phone 124340 0
+61392145585
Fax 124340 0
Email 124340 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
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.