None listed
Conditions
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.
Interventions
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 ma
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.
Sponsors
Associate Professor Nicholas Lintzeris
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
25 Years to 50 Years
Healthy volunteers
Yes
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
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
Outcome results
None listed