Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000189820
Ethics application status
Approved
Date submitted
10/02/2012
Date registered
14/02/2012
Date last updated
14/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A crossover, placebo-controlled trial to determine the impact of independent and combined alcohol and energy drink consumption on risky and impulsive behaviour
Scientific title
For healthy human volunteers, does combined consumption of alcohol and energy drinks compared to independent consumption increase engagement in risky and/or impulsive behaviour
Secondary ID [1] 279918 0
Nil
Universal Trial Number (UTN)
U1111-1126-1583
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol-related harms 285828 0
Condition category
Condition code
Mental Health 286008 286008 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Using a crossover placebo-controlled design the two investigational products under examination will include 0.50g/kg alcohol (vodka; 37.5% alcohol by volume Smirnoff Red Label No. 21) and 3.5ml/kg Red Bull Energy Drink (Red Bull GmBH, Austria). The alcohol dose will be decreased to 85% for females due to their decreased body water to fat ratio. The alcohol dose was selected to achieve an average peak blood alcohol concentration of 0.05% and the energy drink dose is equivalent to one standard 250ml energy drink serving per 70kg person. A 250ml serving of Red Bull Energy Drink contains 21g sucrose, 5g glucose, 1g taurine, 80mg caffeine, 60mg glucuronolactone, 50mg inositol, and B vitamins (niacin, pantothetic acid, vitamin B6 and vitamin B12).

Participants will receive a different treatment condition in each of the four experimental sessions: placebo/placebo, alcohol placebo/energy drink, alcohol/energy drink placebo, and alcohol/energy drink. The two constituents will be mixed together, split into two portions, and served via an opaque lidded cup and straw. Participants will have five minutes to orally consume each portion, resulting in a total beverage consumption time of 10 minutes. Administration of treatment conditions including an alcohol and/or energy drink placebo will be identical to active treatment conditions.

Experimental sessions will be conducted at the same time of day and separated by 7-10 days to ensure complete washout.
Intervention code [1] 284246 0
Treatment: Other
Intervention code [2] 284259 0
Behaviour
Intervention code [3] 284260 0
Lifestyle
Comparator / control treatment
Placebo alcohol will be achieved by floating 10ml alcohol 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] 286498 0
Objective measure of behavioural risk-taking, assessed via mean number of adjusted pumps in a laboratory-based computerised Balloon Analogue Risk Task (Lejeuz et al., 2001).
Timepoint [1] 286498 0
115 minutes post-treatment administration
Primary outcome [2] 286499 0
Objective measure of behavioural inattention impulsivity, assessed via the proportion of commission errors in a laboratory-based computerised Immediate Memory/Delayed Memory Task (Doughtery et al., 2002)
Timepoint [2] 286499 0
40 minutes post-treatment ingestion
Primary outcome [3] 286500 0
Objective measure of behavioural inhibition impulsivity and decision-making impulsivity, assessed via the proportion of commission errors in a laboratory-based computerised Cued Go/No-Go Task and Experiential Discounting Task respectively (Marczinski et al., 2011; Reynolds & Schiffbauer, 2004).
Timepoint [3] 286500 0
60 minutes and 90 minutes post-treatment ingestion respectively
Secondary outcome [1] 296024 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 [1] 296024 0
Baseline, 30 minutes and 130 minutes post-treatment administration
Secondary outcome [2] 296025 0
Perception of general mood state, as assessed using the Profile of Mood States (Loor & McNair, 1971), a self-report adjective rating scale.
Timepoint [2] 296025 0
Baseline, 30 minutes and 130 minutes post-treatment administration
Secondary outcome [3] 296026 0
Perception of 20 somatic symptoms (e.g., increase in sweating, dizziness), as assessed using Visual Analogue Scales
Timepoint [3] 296026 0
Baseline, 30 minutes and 130 minutes post-treatment administration
Secondary outcome [4] 296027 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 [4] 296027 0
Perception of treatment: 30 minutes and 130 minutes post-treatment administration

Perception of general abilities: Baseline, 30 minutes and 130 minutes post-treatment administration
Secondary outcome [5] 296028 0
Perception of alcohol and energy drink intoxication, as assessed using a Beverage Rating Scale (Fillmore & Vogel-Sprott, 2000)
Timepoint [5] 296028 0
130 minutes post-treatment administration
Secondary outcome [6] 296029 0
Changes in blood alcohol concentration, as assessed using a Lion Alcometer Breathalyser
Timepoint [6] 296029 0
Baseline, 30, 40, 60, 90, 115, 130 and 140 minutes post-treatment administration

Eligibility
Key inclusion criteria
Male or female

Aged 18 to 35

English as a first language

Right-handed (laterality quotient between +40 and +100 on the Edinburgh Handedness Index (Oldfield, 1971)

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

Regular caffeine consumer (minimum consumption of two caffeinated beverages in the preceding week).

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

Normal or corrected-to-normal vision

Normal sleep patterns

Normal Body Mass Index (BMI; between 18.50 and 24.99)

Colour vision acuity (score of 9 or higher on Ishihara's (1936) Test for Colour-Blindness
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 (i.e., preceding two weeks) illicit drug use

Current 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 condition or score of 30 or higher on the Kessler Psychological Distress Scale (Kessler et al., 2002).

Current diagnosis of a significant intellectual disability or an age-normed quotient lower than 71 on the Wechsler Test of Adult Reading (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 10 or higher on the Alcohol Disorders Identification Test (Babor et al., 2001)

Extremely sensitive skin

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 randomised to the 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 7 days to ensure complete washout. Sessions will be conducted between 10am and 7pm. Electroencephalographic activity will be collected during the Immediate Memory/Delayed Memory Task and Cued Go/No-Go Task via placement of a non-invasive electrode cap on the scalp.
Phase
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284694 0
Government body
Name [1] 284694 0
Alcohol Tobacco and other Drugs Council of Tasmania
Country [1] 284694 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
Australia 7001
Country
Australia
Secondary sponsor category [1] 283595 0
Government body
Name [1] 283595 0
Alcohol Tobacco and other Drugs Council of Tasmania
Address [1] 283595 0
6/81 Salamanca Place
Battery Point
Hobart
Tasmania
Australia 7004
Country [1] 283595 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286694 0
Human Research Ethics Committee (Tasmania) Network
Ethics committee address [1] 286694 0
Office of Research Services
University of Tasmania
Private Bag 1
Hobart
Tasmania
Australia 7001
Ethics committee country [1] 286694 0
Australia
Date submitted for ethics approval [1] 286694 0
Approval date [1] 286694 0
09/09/2011
Ethics approval number [1] 286694 0
H12010

Summary
Brief summary
The limited existing empirical evidence has generally pointed towards a discrepancy between objective and subjective outcomes following AmED consumption. This discrepancy has been argued to result in increased alcohol consumption and/or risk-taking post-consumption. However, there is a dearth of research (i) supporting this proposed increase in risk-taking, and (ii) attempting to explain the potential mechanisms underlying any changes in risk-taking post-consumption. Consequently, the aim of the current study will be to examine the subjective physiological and psychological outcomes and objective risk and impulsive behavioural outcomes of independent and combined alcohol and energy drink consumption.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33762 0
Address 33762 0
Country 33762 0
Phone 33762 0
Fax 33762 0
Email 33762 0
Contact person for public queries
Name 17009 0
Amy Peacock
Address 17009 0
School of Psychology
University of Tasmania
Private Bag 30
Hobart
Tasmania
Australia 7001
Country 17009 0
Australia
Phone 17009 0
+61 3 62267458
Fax 17009 0
Email 17009 0
[email protected]
Contact person for scientific queries
Name 7937 0
Amy Peacock
Address 7937 0
School of Psychology
University of Tasmania
Private Bag 30
Hobart
Tasmania
Australia 7001
Country 7937 0
Australia
Phone 7937 0
+61 3 62267458
Fax 7937 0
Email 7937 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

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