Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000546954
Ethics application status
Approved
Date submitted
12/05/2011
Date registered
30/05/2011
Date last updated
30/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of mixing alcohol and prescription drugs on driving and cognitive performance: A randomised simulator study.
Scientific title
A double-blind randomised placebo-controlled crossover study investigating the influence of therapeutic doses of codeine and oxazepam, alone and in combination with alcohol, delivered by intravenous infusion, on the extent of impairment on simulated driving and cognitive performance in healthy individuals.
Secondary ID [1] 251883 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
To determine the extent to which commonly prescribed therapeutic doses of codeine and oxazepam, alone and in combination with a moderate dose of alcohol, cause measurable impairment of simulated driving ability and cognitive performance in healthy individuals. 257483 0
Condition category
Condition code
Injuries and Accidents 257635 257635 0 0
Other injuries and accidents
Public Health 266002 266002 0 0
Other public health
Mental Health 266015 266015 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions consist of administration of the following substances in a randomised, counterbalanced order at each testing session:

Arm 1: single oral dose of codeine 60mg (2 x 30mg tabs)
Arm 2: single oral dose of oxazepam 30mg
Arm 3: ethanol (target BAC=0.05g/100ml, dose=0.34g/kg) administered as a bolus oral dose to reach the target BAC (vodka mixed with orange juice in ratio of 1:3), followed by an intravenous infusion of 5% ethanol in 5% dextrose for the remainder of the study period to maintain the participant at a BAC of 0.05g/100ml.

Participants are required to attend a total of 8 testing sessions, in a random order, comprising of the following conditions:

Session 1 - Placebo IV infusion + placebo codeine tablet + placebo oxazepam tablet
Session 2 - Placebo IV infusion + 60mg codeine tablet + placebo oxazepam tablet
Session 3 - Placebo IV infusion + placebo codeine tablet + 30mg oxazepam tablet
Session 4 - Ethanol IV infusion (0.34g/kg) + placebo codeine tablet + placebo oxazepam tablet
Session 5 - Ethanol IV infusion (0.34g/kg) + 60mg codeine tablet + placebo oxazepam tablet
Session 6 - Ethanol IV infusion (0.34g/kg) + placebo codeine tablet + 30mg oxazepam tablet
Session 7 - Placebo IV infusion + 60mg codeine tablet + 30mg oxazepam tablet
Session 8 - Ethanol IV infusion (0.34g/kg) + 60mg codeine tablet + 30mg oxazepam tablet

A washout period of 72 hours between sessions is adopted in this study.
Intervention code [1] 256580 0
Treatment: Drugs
Comparator / control treatment
Placebo of the study medications will be administered in a blinded and randomised manner. The placebos are as follows:

Arm 1 placebo: two lactose tablet matched in appearance to the codeine tablets
Arm 2 placebo: single lactose tablet matched in appearance to the oxazepam tablet
Arm 3 placebo: bolus oral dose of orange juice with 5ml vodka floated on the surface for olfactory masking followed by an intravenous infusion of 5% dextrose solution for the remainder of the study period.
Control group
Placebo

Outcomes
Primary outcome [1] 258546 0
Performances on an advanced driving simulator for each of the study intervention(s) combinations. Performance was measured on parameters of driving such as standard deviation of lateral lane position, mean travel speed, time-to-collision and traffic infringements.
Timepoint [1] 258546 0
On each experimental day, measured prior to administration of any study intervention (baseline), and 2, 3 and 4 hours post administration.
Secondary outcome [1] 264390 0
Performances on higher order cognitive tests for each of the study intervention(s) combinations as measured by the OSPAT and CANTAB systems.
Timepoint [1] 264390 0
On each experimental day, measured prior to administration of any study intervention (baseline), and 2, 3 and 4 hours post administration.

Eligibility
Key inclusion criteria
1. Adequate cognition and English language skills to validly consent and complete study procedures
2. Holds a current drivers licence
3. Able to provide written informed consent
Minimum age
25 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Alcohol naive individuals
2. Lifetime history of any drug or alcohol dependence using ICD-10 criteria (excluding tobacco)
3. Significant medical or psychiatric disorder disorder that may impair study participation or interpretation of data
4. Concurrent use of any prescribed medication (excluding contraception) that may have a pharmacokinetic or pharmacodynamic interaction with alcohol, codeine or oxazepam
5. Epilepsy

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257077 0
Government body
Name [1] 257077 0
National Health and Medical Research Council
Country [1] 257077 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Nicholas Lintzeris
Address
c/o The Langton Centre
591 South Dowling Street
Surry Hills
NSW 2010
Country
Australia
Secondary sponsor category [1] 264159 0
Individual
Name [1] 264159 0
Dr Stefanie Leung
Address [1] 264159 0
Discipline of Addiction Medicine
Central Clinical School
The University of Sydney
NSW 2006
Country [1] 264159 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The purpose of this study is to explore the individual and combined effects of common prescription medicines, at therapeutic doses, on driving performance. It is hypothesised that, while the interventions alone may not cause impairment, the combined effect of the medications will have an additive effect on driving performance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31234 0
Address 31234 0
Country 31234 0
Phone 31234 0
Fax 31234 0
Email 31234 0
Contact person for public queries
Name 14481 0
Dr Stefanie Leung
Address 14481 0
Discipline of Addiction Medicine
Central Clinical School
The University of Sydney
NSW 2006
Country 14481 0
Australia
Phone 14481 0
+612 9515 8972
Fax 14481 0
Email 14481 0
[email protected]
Contact person for scientific queries
Name 5409 0
Dr Stefanie Leung
Address 5409 0
Discipline of Addiction Medicine
Central Clinical School
The University of Sydney
NSW 2006
Country 5409 0
Australia
Phone 5409 0
+612 9515 8972
Fax 5409 0
Email 5409 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.