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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
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Scientific title
A pilot study to characterise gaze patterns during driving among people who use methamphetamine versus people who have not used methamphetamine
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Secondary ID [1]
308886
0
Nil
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Universal Trial Number (UTN)
U1111-1287-7991
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Trial acronym
Meth-gaze
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Substance use
328880
0
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Condition category
Condition code
Injuries and Accidents
325874
325874
0
0
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Other injuries and accidents
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Mental Health
326018
326018
0
0
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Addiction
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
325333
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Not applicable
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
333712
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Differences between the two groups on eye movement behaviour during driving
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Assessment method [1]
333712
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Timepoint [1]
333712
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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.
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Primary outcome [2]
333713
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Differences between the groups on driving performance
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Assessment method [2]
333713
0
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Timepoint [2]
333713
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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.
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Primary outcome [3]
333714
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Differences between the two groups on eye movement behaviour during driving
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Assessment method [3]
333714
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Timepoint [3]
333714
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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.
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Secondary outcome [1]
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Differences between the two groups on eye movement behaviour during Visuospatial Working Memory (VSWM) task
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Assessment method [1]
418002
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Timepoint [1]
418002
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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.
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Secondary outcome [2]
418003
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Differences between the two groups on cognitive performance (reaction and movement time)
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Assessment method [2]
418003
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Timepoint [2]
418003
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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.
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Secondary outcome [3]
418004
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Differences between the two groups on cognitive performance (memory score)
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Assessment method [3]
418004
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Timepoint [3]
418004
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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.
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Secondary outcome [4]
418005
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Differences between the two groups on cognitive performance (target sensitivity)
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Assessment method [4]
418005
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Timepoint [4]
418005
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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.
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Secondary outcome [5]
418006
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Differences between the two groups on cognitive performance (Spatial Working Memory strategy score)
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Assessment method [5]
418006
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Timepoint [5]
418006
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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.
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Secondary outcome [6]
418007
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Differences between the two groups on cognitive performance (Spatial Working Memory errors)
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Assessment method [6]
418007
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Timepoint [6]
418007
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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.
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Secondary outcome [7]
418008
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Differences between the two groups on cognitive performance (overall task score - Driving Under the Influence of Drugs, DRUIDApp).
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Assessment method [7]
418008
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Timepoint [7]
418008
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Specifically, this will occur at 80 minutes and 195 minutes of the testing session. This will be assessed using the DRUID test battery.
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Secondary outcome [8]
418009
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Differences between the two groups on eye movement behaviour during driving (PRIMARY OUTCOME)
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Assessment method [8]
418009
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Timepoint [8]
418009
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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.
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Secondary outcome [9]
418010
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Differences between the two groups on eye movement behaviour during driving (PRIMARY OUTCOME)
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Assessment method [9]
418010
0
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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.
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Secondary outcome [10]
418011
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Differences between the two groups on driving (PRIMARY OUTCOME)
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Assessment method [10]
418011
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Timepoint [10]
418011
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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
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Secondary outcome [11]
418012
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Differences between the two groups on driving (PRIMARY OUTCOME)
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Assessment method [11]
418012
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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
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Secondary outcome [12]
418013
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Differences between the two groups on driving (PRIMARY OUTCOME)
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Assessment method [12]
418013
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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
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Secondary outcome [13]
418014
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To identify the differences between the two groups on driving on subjective driving ability
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Assessment method [13]
418014
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Timepoint [13]
418014
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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.
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Secondary outcome [14]
418015
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To identify the differences between the two groups on subjective on mental load
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Assessment method [14]
418015
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Timepoint [14]
418015
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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
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Secondary outcome [15]
418016
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To identify the differences between the two groups on state anxiety
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Assessment method [15]
418016
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Timepoint [15]
418016
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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”).
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Secondary outcome [16]
418017
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To identify the differences between the two groups on subjective aggression
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Assessment method [16]
418017
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Timepoint [16]
418017
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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
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Secondary outcome [17]
418018
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Differences between the two groups on eye movement behaviour during driving (PRIMARY OUTCOME)
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Assessment method [17]
418018
0
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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.
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Secondary outcome [18]
418020
0
Differences between the two groups on driving (PRIMARY OUTCOME)
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Assessment method [18]
418020
0
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Timepoint [18]
418020
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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
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Secondary outcome [19]
418022
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Differences between the two groups on eye movement behaviour during Visuospatial Working Memory (VSWM) task
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Assessment method [19]
418022
0
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Timepoint [19]
418022
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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.
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Secondary outcome [20]
418023
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Differences between the two groups on eye movement behaviour during Visuospatial Working Memory (VSWM) task
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Assessment method [20]
418023
0
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Timepoint [20]
418023
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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
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Secondary outcome [21]
418024
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Identify plasma blood concentrations of methamphetamine among people who use methamphetamine
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Assessment method [21]
418024
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Timepoint [21]
418024
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Using venupuncture procedure. Specifically, this will occur at approximately 55 minutes and 205 minutes of the testing session.
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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
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Minimum age
21
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Case control
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Timing
Prospective
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/04/2023
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
23902
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Eastern Health - Box Hill
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Recruitment hospital [2]
23903
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St Vincent's Hospital (Melbourne) Ltd - Fitzroy
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Recruitment hospital [3]
23904
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Swinburne University of Technology - Hawthorn
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Recruitment postcode(s) [1]
39386
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3128 - Box Hill
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Recruitment postcode(s) [2]
39387
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3065 - Fitzroy
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Recruitment postcode(s) [3]
39388
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3122 - Hawthorn
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Funding & Sponsors
Funding source category [1]
313101
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University
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Name [1]
313101
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Swinburne University of Technology
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Address [1]
313101
0
427-451 Burwood Road
Hawthorn,
Victoria, 3122
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Country [1]
313101
0
Australia
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Primary sponsor type
University
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Name
Swinburne University of Technology
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Address
427-451 Burwood Road
Hawthorn,
Victoria, 3122
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Country
Australia
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Secondary sponsor category [1]
314802
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None
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Name [1]
314802
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None
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Address [1]
314802
0
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Country [1]
314802
0
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Other collaborator category [1]
282537
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Hospital
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Name [1]
282537
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Turning Point Eastern Treatment Services
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Address [1]
282537
0
Ground Floor/43 Carrington Rd, Box Hill VIC 3128
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Country [1]
282537
0
Australia
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Other collaborator category [2]
282540
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Hospital
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Name [2]
282540
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Addiciton Medicine at St Vincent's Hospital
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Address [2]
282540
0
62 Gertrude Street,
Fitzroy, VIC 3065
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Country [2]
282540
0
Australia
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
312348
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Swinburne University Human Research Ethics Committee
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Ethics committee address [1]
312348
0
Swinburne Research (H68),
Swinburne University of Technology,
P O Box 218,
Hawthorn, Victoria, 3122.
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Ethics committee country [1]
312348
0
Australia
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Date submitted for ethics approval [1]
312348
0
03/03/2023
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Approval date [1]
312348
0
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Ethics approval number [1]
312348
0
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Ethics committee name [2]
312351
0
Eastern Health Human Research Ethics Committee
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Ethics committee address [2]
312351
0
5 Arnold Street
Box Hill, VIC, 3128
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Ethics committee country [2]
312351
0
Australia
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Date submitted for ethics approval [2]
312351
0
24/03/2023
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Approval date [2]
312351
0
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Ethics approval number [2]
312351
0
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Ethics committee name [3]
312352
0
St Vincent's Hospital Melbourne Human Research Ethics Committee (HREC)
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Ethics committee address [3]
312352
0
62 Gertrude Street,
Fitzroy, VIC 3065
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Ethics committee country [3]
312352
0
Australia
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Date submitted for ethics approval [3]
312352
0
24/03/2023
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Approval date [3]
312352
0
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Ethics approval number [3]
312352
0
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Summary
Brief summary
This research will investigate whether long-term methamphetamine use produces changes to driving ability in the absence of acute intoxication, and whether this can be effectively indexed and monitored through objective markers of performance. Using our high-fidelity driving simulator with advanced simultaneous eye-monitoring technologies, we will use real-time analysis of head position and eye movements to examine the relationship between gaze vector and driver behaviour to better understand the impact of methamphetamine addiction on driving performance in separate groups of 1.) individuals who use methamphetamine and 2) healthy adults who have no history of the use of psychostimulants and have no history of chronic/binge use of psychoactive substances.
We expect that there will be a measurable difference in the patterns of eye movements displayed during driving by individuals who use methamphetamine versus those who have no history of the use of psychostimulants or no history of chronic/binge use of psychoactive substances
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
124338
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Dr Amie Hayley
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Address
124338
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Swinburne University of Technology,
School of Health Sciences
Centre for Mental Health and Brain Sciences
Mail H24
PO Box 218
Hawthorn, Victoria, 3122
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Country
124338
0
Australia
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Phone
124338
0
+61392145585
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Fax
124338
0
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Email
124338
0
[email protected]
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Contact person for public queries
Name
124339
0
Dr Amie Hayley
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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
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Country
124339
0
Australia
Query!
Phone
124339
0
+61392145585
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Fax
124339
0
Query!
Email
124339
0
[email protected]
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Contact person for scientific queries
Name
124340
0
Dr Amie Hayley
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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
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Country
124340
0
Australia
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Phone
124340
0
+61392145585
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Fax
124340
0
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Email
124340
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Due to the sensitive nature of the data collected, we will not be making IPD available.
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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.
Download to PDF