Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000796886
Ethics application status
Not yet submitted
Date submitted
24/07/2012
Date registered
30/07/2012
Date last updated
30/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A crossover, single-blind, placebo-controlled study to determine the dose-dependent impact of independent and combined alcohol and energy drink consumption on cognitive and motor performance, physiology, and behavioural risk-taking outcomes
Scientific title
For healthy human volunteers, what is the dose-dependent independent and combined impact of alcohol and energy drinks on cognitive and motor performance, physiology, and behavioural risk-taking outcomes
Secondary ID [1] 280905 0
Nil
Universal Trial Number (UTN)
U1111-1132-9420
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol-related harms 286985 0
Condition category
Condition code
Mental Health 287319 287319 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will utilise a crossover placebo-controlled, single-blind mixed design.

The two investigational products under examination will include 0.50g/kg and 0.65g/kg alcohol (vodka; 37.5% alcohol by volume Smirnoff Red Label No. 21) and 250ml, 500ml, and 750ml Red Bull (Registered Trademark) Energy Drink (Red Bull GmBH, Austria). The alcohol doses were selected to achieve an average peak blood alcohol concentration of 0.05% and 0.08% and the energy drink dose is equivalent to one, two, and three standard energy drinks servings (i.e., 250ml containing 21g sucrose, 5g glucose, 1g taurine, 80mg caffeine, 60mg glucuronolactone, 50mg inositol, and B vitamins). The alcohol dose will be decreased to 85% for females due to their decreased body water to fat ratio.

Participants will be randomly allocated to one of three alcohol treatment conditions (placebo, 0.50g/kg, or 0.65g/kg) counterbalanced for sex. They will then attend four experimental sessions in which they will receive their allocated alcohol dose with a different energy drink dose (placebo, 250ml, 500ml, and 750ml Red Bull Energy Drink), administered in counterbalanced order.

Administration of placebo and active alcohol and energy drink treatment conditions will be identical. The alcohol and energy drink portions will be poured together to form a mixed beverage, which will then be split into four portions and served in opaque lidded cups with a straw. Participants will have four successive five minutes blocks to orally consume each portion at their own pace, resulting in a total consumption time of 20 minutes.

Experimental sessions will be conducted at the same time of day for each participant between the hours of 0900 and 1900, with a minimum of two days and a maximum of 10 days separating sessions to ensure washout.
Intervention code [1] 285338 0
Treatment: Other
Intervention code [2] 285339 0
Behaviour
Intervention code [3] 285340 0
Lifestyle
Comparator / control treatment
Placebo alcohol will be achieved by floating 5ml alcohol/250ml energy drink on top of the energy drink constituent and spraying the opaque lidded cup with a fine alcohol mist. Placebo energy drink will be achieved via administration of a Red Bull Energy Drink minus the active ingredients (excluding glucose and sucrose). Those active ingredients removed will include caffeine, taurine, glucuronolactone, inositol,and vitamin B complex.
Control group
Placebo

Outcomes
Primary outcome [1] 287594 0
Objective measure of tracking, assessed via performance score on the the Occupational Performance Safety Assessment Test (OSPAT Pty Ltd, 2005)
Timepoint [1] 287594 0
40 minutes post-treatment administration
Primary outcome [2] 287595 0
Objective measure of sustained attention, assessed via mean reaction time, hits, misses, false alarms, and correction rejections on the Rapid Visual Processing Task, Cambridge Neuropsychological Test Automated Battery (CANTAB; Cambridge Cognition, 2005)
Timepoint [2] 287595 0
51 minutes post-treatment administration
Primary outcome [3] 287596 0
Objective measure of response inhibition, assessed via the mean 'stop' reaction time on the Stop Signal Task (CANTAB, Cambridge Cognition, 2005)
Timepoint [3] 287596 0
58 minutes post-treatment administration
Secondary outcome [1] 298487 0
Objective measure of sensory-motor performance, assessed via the mean simple and choice RT on the Reaction Time Index (CANTAB, Cambridge Cognition, 2005)
Timepoint [1] 298487 0
45 minutes post-treatment administration
Secondary outcome [2] 298488 0
Objective measure of information processing speed, assessed via the mean exposure duration at 90% accuracy on the Inspection Time Task (O'Connor & Burns, 2003)
Timepoint [2] 298488 0
70 minutes post-treatment administration
Secondary outcome [3] 298489 0
Objective measure of postural control, assessed via the sway area (mm2) while standing quietly with eyes open and eyes closed
Timepoint [3] 298489 0
82 minutes post-treatment administration
Secondary outcome [4] 298490 0
Objective measure of fine and gross motor movement, assessed via the number of pegs accurately placed within the hole for each trial type (right hand, left hand, both hands) and number of completed pin/collar/washer/pin assesmblies
Timepoint [4] 298490 0
90 minutes post-treatment administration
Secondary outcome [5] 298491 0
Objective measure of heart rate, assessed via a Polar RS800CX
Timepoint [5] 298491 0
28, 38, 80, 95, and 141 minutes post-treatment administration
Secondary outcome [6] 298492 0
Objective measure of mean, systolic and diastolic blood pressure, assessed via a standard Omron portable automatic professional digital blood pressure system
Timepoint [6] 298492 0
28, 38, 80, 95, and 141 minutes post-treatment administration
Secondary outcome [7] 298493 0
Objective measure of blood alcohol concentration, assessed via a Alcolizer HH-2 Breathalyser
Timepoint [7] 298493 0
29, 39, 81, 96, and 142 post-treatment administration
Secondary outcome [8] 298494 0
Perception of sedation and stimulation, as assessed using the Biphasic Alcohol Effects Scale (Martin et al., 1993), a self-report unipolar adjective rating scale.
Timepoint [8] 298494 0
Baseline, 30 minutes and 143 minutes post-treatment administration
Secondary outcome [9] 298495 0
Perception of general mood state, as assessed using the Profile of Mood States (Loor & McNair, 1971), a self-report adjective rating scale.
Timepoint [9] 298495 0
Baseline, 30 minutes and 143 minutes post-treatment administration
Secondary outcome [10] 298496 0
Perception of 20 somatic symptoms (e.g., increase in sweating, dizziness), as assessed using Visual Analogue Scales
Timepoint [10] 298496 0
Baseline, 30 minutes and 143 minutes post-treatment administration
Secondary outcome [11] 298497 0
Perception of the treatment and general abilities (e.g., general impairment, driving ability), as assessed using Visual Analogue Scales (Beirness, 1987; Fillmore, 2001)
Timepoint [11] 298497 0
Perception of treatment: 30 minutes and 143 minutes post-treatment administration

Perception of general abilities: Baseline, 30 minutes and 143 minutes post-treatment administration
Secondary outcome [12] 298498 0
Perception of alcohol and energy drink intoxication, as assessed using a Beverage Rating Scale (Fillmore & Vogel-Sprott, 2000)
Timepoint [12] 298498 0
143 minutes post-treatment administration

Eligibility
Key inclusion criteria
Male or female

Aged 18 to 35

English as a first language

Completed Year 12 or equivalent

Current full driver licence

Regular energy drink consumer (minimum consumption of one energy drink and maximum consumption of one energy drink per day on average in the preceding month)

Regular caffeine consumer (minimum consumption of five and maximum consumption of 28 caffeinated products in the preceding week)

Regular alcohol consumer (minimum consumption of two standard alcoholic beverages in the preceding fortnight)

Normal or corrected-to-normal vision

Normal sleep patterns

Normal Body Mass Index (BMI; between 18.50 and 29.99)

Provided informed consent
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Regular tobacco smoker (typical daily use of one or more cigarettes)

Recent illicit drug use (preceding two weeks)

Current regular medicinal or recreational prescription medication use (excluding the contraceptive pill)

Participation in a drug study in the preceding three months

Currently pregnant or breastfeeding

History of any significant neurological condition

Current diagnosis of any significant physical condition

Current diagnosis of a significant psychiatric disorder or score of 30 or higher on the Kessler Psychological Distress Scale (K10; Kessler et al., 2002)

Current diagnosis of a significant intellectual disability or age normed quotient lower than 71 on the Wechsler Test of Adult Reading (WTAR; Wechsler, 2001)

History of alcohol or drug abuse or dependence disorder or use of alcohol at hazardous or harmful levels, evident via a score of 16 or higher on the Alcohol Use Disorders Identification Test (AUDIT; Barbor et al., 2001; Saunders, Aasland, Babor, de la Fuente, & Grant, 1993)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participant eligibility will be ascertained via telephone screening and attendance at a familiarisation session. Treatment order allocation will occur following confirmation of eligibility and will be achieved by contacting the holder of the allocation schedule who will be at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned a treatment code counterbalanced for sex corresponding to a counterbalanced treatment administration order by a research associate not involved in the study on confirmation of eligibility.

Participants will be randomised an energy drink treatment condition order via permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
The four experimental sessions will be separated by a minimum of 2 and a maximum of 10 days to ensure complete washout. Session times will be consistent for each participant and conducted between 9am and 7pm.
Phase
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285695 0
Government body
Name [1] 285695 0
Mental Health and Drug and Alcohol Office, New South Wales Health
Country [1] 285695 0
Australia
Primary sponsor type
University
Name
School of Psychology, University of Tasmania
Address
School of Psychology
University of Tasmania
Private Bag 30
Hobart, Tasmania 7001
Australia
Country
Australia
Secondary sponsor category [1] 284524 0
Government body
Name [1] 284524 0
Turning Point Alcohol and Drug Centre, Eastern Health
Address [1] 284524 0
Turning Point Alcohol and Drug Centre
54-62 Gertrude Street
Fitzroy, Victoria 3065
Australia
Country [1] 284524 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287692 0
Ethics committee address [1] 287692 0
Ethics committee country [1] 287692 0
Date submitted for ethics approval [1] 287692 0
15/08/2012
Approval date [1] 287692 0
Ethics approval number [1] 287692 0

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

Contacts
Principal investigator
Name 34481 0
Address 34481 0
Country 34481 0
Phone 34481 0
Fax 34481 0
Email 34481 0
Contact person for public queries
Name 17728 0
Amy Peacock
Address 17728 0
School of Psychology
University of Tasmania
Private Bag 30
Hobart Tasmania 7001
Country 17728 0
Australia
Phone 17728 0
+61 3 6226 2885
Fax 17728 0
+61 3 6226 2883
Email 17728 0
[email protected]
Contact person for scientific queries
Name 8656 0
Amy Peacock
Address 8656 0
School of Psychology
University of Tasmania
Private Bag 30
Hobart Tasmania 7001
Country 8656 0
Australia
Phone 8656 0
+61 3 6226 2885
Fax 8656 0
Email 8656 0
[email protected]

No information has been provided regarding IPD availability


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.