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Trial registered on ANZCTR


Registration number
ACTRN12621001209886
Ethics application status
Approved
Date submitted
13/07/2021
Date registered
10/09/2021
Date last updated
10/09/2021
Date data sharing statement initially provided
10/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Acute Alcohol Intoxication and Alcohol Hangover on Cognitive and Driving Performance: A Randomized Control Trial
Scientific title
The Effects of Acute Alcohol Intoxication and Alcohol Hangover on Cognitive and Driving Performance: A Randomized Control Trial of an Adult sample
Secondary ID [1] 304741 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Alcohol Intoxication 322774 0
Alcohol Hangover 322775 0
Condition category
Condition code
Metabolic and Endocrine 320359 320359 0 0
Normal metabolism and endocrine development and function
Mental Health 320764 320764 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Alcohol is the intervention being assessed across two study Arms. Alcohol will be consumed twice in Arm 1, once in Arm 2a and once in Arm 2b. Overall, participants will attend the testing site on 7 occasions, 6 for testing and 1 screening.

Arm 1:
This arm involves 3 test sessions where 0.0 g/kg (placebo), 0.6 g/kg and 0.85 g/kg of alcohol will be administered. 2 of these visits will coincide with Arm 2a. This is as follows:
i) Arm 1 placebo (0.0 g/kg), followed by Arm 2a (no alcohol administered)
ii) Arm 1 involving 0.6 g/kg (no association to Arm 2a)
iii) Arm 1 involving 0.85 g/kg, followed by Arm 2a where additional alcohol is administered up to 1.3 g/kg (accounting for alcohol already consumed).
Arm 1 visits will be randomized and commence between 4-6 pm.
Alcohol will be Absolut brand vodka mixed with original black label orange juice. Participants are allocated 20 minutes to consume alcohol with the exception of the Arm 2a 1.3 g/kg condition where extra time is allowed (see below).
Alcohol will be served by a research assistant (with responsible service of alcohol certification), at the instruction of the principle investigator. Alcohol administration will also be supervised by a research nurse.
A research assistant and the research nurse will be present to monitor adherence to the intervention.
Each visit will separated by no less than 5 days and no more than 14 days.

Arm 2a:
This Arm involves 2 test sessions: no alcohol and 1.3 g/kg alcohol. The 2 visits follow the Arm 1 visits described above. Participants are allowed up to 2 hours to consume extra beverages in 1.3 g/kg condition with a mandatory 20 minute absorption period to follow.
Alcohol will be served by a research assistant. Participants will be monitored by a research assistant and research nurse and are not obliged to consume all allocated beverages.
Following administration of the intervention participants will be sent home for the evening (by taxi) before returning to the test site the following morning for the non-hangover (no alcohol) and hangover (1.3 g/kg) test sessions. These sessions will be between 8-11 hrs after alcohol consumption and will be scheduled between 7-11 am.

Arm 2b:
This Arm occurs after the completion of Arm 1 and 2a and involves 2 visits: no hangover and hangover.
Participants will consume alcohol on a normal night out unrestricted, and attend testing the following morning when experiencing a hangover. The no hangover session will follow a night of alcohol abstinence. Test sessions will be scheduled between 7-11 am.
Participants will contacted the morning of the test session to ensure they are attending (both sessions) and are feeling well enough to attend (hangover session only). Participant compliance will also be monitored by self-report assessments of hangover severity and BAC readings of 0.00%.
Test visits will be randomized and no less than 5 days and no more than 14 days apart.
Intervention code [1] 321113 0
Behaviour
Comparator / control treatment
Arm 1: and 2a
Placebo beverage will be orange juice with a small amount of alcohol wiped over the rim of a glass to enhance treatment blinding

Arm 2b:
Testing follows a night of no alcohol consumption.
Participant compliance will be monitored by self-report assessments of hangover severity and questions regarding whether they refrained from alcohol. This will be accompanied by mandatory breath alcohol readings of 0.00%.upon arrival to the test site.
Control group
Placebo

Outcomes
Primary outcome [1] 328201 0
Simulated Driving:
Measured over a 20 minute drive using the Forum 8 UC win/road driving simulator.
Performance will be measured by the standard deviation of lateral position (SDLP), a standard measure of weaving of the car, and the standard deviation of speed (km/hr).


Timepoint [1] 328201 0
Arm 1:
45 minutes after alcohol or placebo beverage consumption

Arm 2a
8-11 hours following alcohol or no alcohol consumption. In the morning between 7-11 am.

Arm 2b:
In the morning between 7-11 am after alcohol or no alcohol is consumed.
Alcohol consumption will not be monitored so the period of time following last beverage consumption will vary. BAC will be 0.00%.
Primary outcome [2] 328202 0
Cognitive Performance:
Measured by the Reaction Time test on the Schuhfried Vienna Test System,
Participants respond to certain visual and auditory stimuli. Performance measured by reaction time and errors
Timepoint [2] 328202 0
Arm 1:
45 minutes after alcohol or placebo beverage consumption

Arm 2a
8-11 hours following alcohol or no alcohol consumption. In the morning between 7-11 am.

Arm 2b:
In the morning between 7-11 am after alcohol or no alcohol is consumed.
Alcohol consumption will not be monitored so the period of time following last beverage consumption will vary. BAC will be 0.00%.
Primary outcome [3] 328205 0
Arm 2a and 2b:
Hangover Severity
23 item hangover scales measuring symptoms and their severity on a Likert scale from 0 to 10 and a single-item overall hangover severity score
Timepoint [3] 328205 0
Arm 2a
8-11 hours following alcohol or no alcohol consumption. In the morning between 7-11 am.

Arm 2b:
In the morning between 7-11 am after alcohol or no alcohol is consumed.
Alcohol consumption will not be monitored so the period of time following last beverage consumption will vary. BAC will be 0.00%.
Secondary outcome [1] 398014 0
Subjective driving performance
Measured by single-item visual analogue scale
Timepoint [1] 398014 0
Arm 1:
45 minutes after alcohol or placebo beverage consumption

Arm 2a
8-11 hours following alcohol or no alcohol consumption. In the morning between 7-11 am.

Arm 2b:
In the morning between 7-11 am after alcohol or no alcohol is consumed.
Alcohol consumption will not be monitored so the period of time following last beverage consumption will vary. BAC will be 0.00%.
Secondary outcome [2] 398015 0
Willingness to drive
Measured by single-item visual analogue scale
Timepoint [2] 398015 0
Arm 1:
45 minutes after alcohol or placebo beverage consumption

Arm 2a
8-11 hours following alcohol or no alcohol consumption. In the morning between 7-11 am.

Arm 2b:
In the morning between 7-11 am after alcohol or no alcohol is consumed.
Alcohol consumption will not be monitored so the period of time following last beverage consumption will vary. BAC will be 0.00%.
Secondary outcome [3] 398016 0
NASA Task Load Index
Measures perceived workload on 6 visual analogue scales
Timepoint [3] 398016 0
Arm 1:
45 minutes after alcohol or placebo beverage consumption

Arm 2a
8-11 hours following alcohol or no alcohol consumption. In the morning between 7-11 am.

Arm 2b:
In the morning between 7-11 am after alcohol or no alcohol is consumed.
Alcohol consumption will not be monitored so the period of time following last beverage consumption will vary. BAC will be 0.00%.
Secondary outcome [4] 398017 0
Groningen Sleep Quality Scale (GSQS)
Timepoint [4] 398017 0
Arm 1:
45 minutes after alcohol or placebo beverage consumption

Arm 2a
8-11 hours following alcohol or no alcohol consumption. In the morning between 7-11 am.

Arm 2b:
In the morning between 7-11 am after alcohol or no alcohol is consumed.
Alcohol consumption will not be monitored so the period of time following last beverage consumption will vary. BAC will be 0.00%.
Secondary outcome [5] 398018 0
Karolinska Sleepiness Scale
Timepoint [5] 398018 0
Arm 1:
45 minutes after alcohol or placebo beverage consumption

Arm 2a
8-11 hours following alcohol or no alcohol consumption. In the morning between 7-11 am.

Arm 2b:
In the morning between 7-11 am after alcohol or no alcohol is consumed.
Alcohol consumption will not be monitored so the period of time following last beverage consumption will vary. BAC will be 0.00%.
Secondary outcome [6] 398019 0
Breath Alcohol Concentration
measured by a Lion SD400PA breathalyzer that will be regularly calibrated be the Victoria Police drug and alcohol unit
Timepoint [6] 398019 0
Arm 1:
Before alcohol consumption, 45 minutes after alcohol consumption to ensure target BAC is reached, after driving (approximately 65-75 minutes after alcohol consumption) and after testing completion (between 90-100 minutes after alcohol consumption)

Arm 2a (1.3 g/kg condition):
Before more alcohol is administered, 20 minutes following last alcohol consumption.
The following morning 8-11 hours after alcohol consumption or no alcohol

Arm 2b:
In the morning between 7-11 am after alcohol or no alcohol is consumed.
Alcohol consumption will not be monitored so the period of time following last beverage consumption will vary. BAC will be 0.00%.
Secondary outcome [7] 398020 0
Estimated Alcohol Consumption
Measured by participants recall of alcohol consumed the evening before hangover visit
Timepoint [7] 398020 0
Arm 2b only:
In the morning between 7-11 am after alcohol or no alcohol is consumed.
Alcohol consumption will not be monitored so the period of time following last beverage consumption will vary. BAC will be 0.00%.
Secondary outcome [8] 398021 0
Participants estimated Blood Alcohol Concentration
Calculated by the participants responses to estimated alcohol consumed, the start and stop time of drinking and the participants gender and weight.
Timepoint [8] 398021 0
Arm 2b only:
In the morning between 7-11 am after alcohol or no alcohol is consumed.
Alcohol consumption will not be monitored so the period of time following last beverage consumption will vary. BAC will be 0.00%.
Secondary outcome [9] 399535 0
Primary Outcome [4]
Cognitive Performance
Measured by the determination test on the Schuhfried Vienna Test System,
Participants respond to random auditory and visual stimuli with hands and feet. Performance outcomes are average reaction time, number of stimuli presented and accuracy of responses
Timepoint [9] 399535 0
Arm 1:
45 minutes after alcohol or placebo beverage consumption

Arm 2a
8-11 hours following alcohol or no alcohol consumption. In the morning between 7-11 am.

Arm 2b:
In the morning between 7-11 am after alcohol or no alcohol is consumed.
Alcohol consumption will not be monitored so the period of time following last beverage consumption will vary. BAC will be 0.00%.
Secondary outcome [10] 399536 0
Primary Outcome [5]
Cognitive Performance
Measured by the Visual Pursuit test on the Schuhfried Vienna Test System
Participants visually track lines in a display. Time to complete and errors are outcome measures
Timepoint [10] 399536 0
Arm 1:
45 minutes after alcohol or placebo beverage consumption

Arm 2a
8-11 hours following alcohol or no alcohol consumption. In the morning between 7-11 am.

Arm 2b:
In the morning between 7-11 am after alcohol or no alcohol is consumed.
Alcohol consumption will not be monitored so the period of time following last beverage consumption will vary. BAC will be 0.00%.
Secondary outcome [11] 399537 0
Primary Outcome [6]
Cognitive Performance
Measured by the Adaptive Tachistoscopic Traffic Perception (ATAVT) test on the Schuhfried Vienna Test System,
Participants indicate what items are present in an image displayed briefly on screen. average working time and errors recorded.
Timepoint [11] 399537 0
Arm 1:
45 minutes after alcohol or placebo beverage consumption

Arm 2a
8-11 hours following alcohol or no alcohol consumption. In the morning between 7-11 am.

Arm 2b:
In the morning between 7-11 am after alcohol or no alcohol is consumed.
Alcohol consumption will not be monitored so the period of time following last beverage consumption will vary. BAC will be 0.00%.

Eligibility
Key inclusion criteria
Regularly consume alcohol in doses that produce hangover, full or provisional (Level P2) drivers license, and in general good health
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current or history of alcohol/drug abuse or psychiatric disorders, current medically treated liver or renal impairment; regular smokers; if female; pregnant or breast-feeding; use of any medication that may interact with alcohol; weighing >100kg, never experienced a hangover; does not consume alcohol on a single occasion to equate to a BAC of approximately 0.12%; susceptibility to simulator adaptation syndrome

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)
Arm 1 only:
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Arm 1 only:
Simple randomisation using a randomisation table from a statistics book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Arm 1:
Blinded

Arm 2a and 2b:
No blinding used
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size estimations for the primary outcome variables were conducted using G*Power 3.1.7. Effect sizes were determined using results from previous studies. Statistical power was set at 90% with a significance level of 0.05, A sample of 32 was deemed appropriate. To account for attrition, 35 participants will be recruited.

Primary outcomes will be assessed using mixed model repeated measures. Secondary outcomes will be analysed by one-way repeated measures ANOVA and/or paired sample t-tests

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 309099 0
University
Name [1] 309099 0
Swinburne University of Technology Center for Human Psychopharmacology
Country [1] 309099 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology Center for Human Psychopharmacology
Address
427-451 Burwood Road, Hawthorn, Victoria, 3122
Country
Australia
Secondary sponsor category [1] 310043 0
None
Name [1] 310043 0
Address [1] 310043 0
Country [1] 310043 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308965 0
Swinburne University Human research Ethics Committee (SUHREC)
Ethics committee address [1] 308965 0
John Street, Hawthorn, Victoria, 3122
Ethics committee country [1] 308965 0
Australia
Date submitted for ethics approval [1] 308965 0
07/02/2020
Approval date [1] 308965 0
21/05/2020
Ethics approval number [1] 308965 0
20202764-4446

Summary
Brief summary
The primary objectives of this 2-Arm trial are to; 1) further ascertain the effects of various levels of acute alcohol (Arm 1) and alcohol-hangover (Arm 2) on simulated driving performance and cognitive functioning; 2) compare the results of simulated driving performance with findings from a battery of cognitive tests (Schuhfried Vienna Test System) to examine the effectiveness of Schuhfried in evaluating driver performance; and 3) validate the use of a semi-naturalistic research design in measuring the effects of alcohol-hangover.
A total of 35 healthy participants, aged 18-40 years will complete this within-subjects crossover trial.
Arm 1 of the trial is single-blinded and involves three administrations of alcohol 0.0 g/kg, 0.65 g/kg and 0.85 g/kg across separate sessions to achieve BACs of 0.00%, 0.05% and 0.08%. Alcohol will be Vodka mixed with orange juice in the alcohol conditions.
Arm 2 is a trial on alcohol hangover in two phases.
Arm 2a follows two visits in Arm 1, placebo and 0.85 g/kg conditions. Further alcohol will be administered after the 0.85 g/kg session. Up to 1.3 g/kg alcohol will be administered accounting for alcohol already consumed. Participants will be assessed the morning following alcohol consumption and after the placebo condition where no alcohol is consumed.
Arm 2b of the trial is a semi-naturalistic study design. Participants consume alcohol on a 'normal' night out. Participants will be assessed the morning following alcohol consumption and a night of no alcohol.
At all test sessions, participants will complete simulated driving, cognitive measures and questionnaires including perceived performance, willingness to drive and sleep
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112502 0
Dr Sarah Benson
Address 112502 0
Swinburne University, PO Box 218, Hawthorn, Victoria, 3122
Country 112502 0
Australia
Phone 112502 0
+61 3 9214 5212
Fax 112502 0
Email 112502 0
[email protected]
Contact person for public queries
Name 112503 0
Dr Sarah Benson
Address 112503 0
Swinburne University, PO Box 218, Hawthorn, Victoria, 3122
Country 112503 0
Australia
Phone 112503 0
+61 3 9214 5212
Fax 112503 0
Email 112503 0
[email protected]
Contact person for scientific queries
Name 112504 0
Dr Sarah Benson
Address 112504 0
Swinburne University, PO Box 218, Hawthorn, Victoria, 3122
Country 112504 0
Australia
Phone 112504 0
+61 3 9214 5212
Fax 112504 0
Email 112504 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
anyone who provides a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in an approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator: Dr. Sarah Benson ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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