RecruitingACTRN12611000546954

The effects of mixing alcohol and prescription drugs on driving and cognitive performance: A randomised simulator study.

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.

Sponsor

Associate Professor Nicholas Lintzeris

Enrollment

42 participants

Start Date

Jun 11, 2010

Study Type

Interventional

Conditions

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.

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.

Eligibility

Sex: Both males and femalesMin Age: 25 YearssMax Age: 50 Yearss

Inclusion Criteria3

Adequate cognition and English language skills to validly consent and complete study procedures
Holds a current drivers licence
Able to provide written informed consent

Exclusion Criteria5

Alcohol naive individuals
Lifetime history of any drug or alcohol dependence using ICD-10 criteria (excluding tobacco)
Significant medical or psychiatric disorder disorder that may impair study participation or interpretation of data
Concurrent use of any prescribed medication (excluding contraception) that may have a pharmacokinetic or pharmacodynamic interaction with alcohol, codeine or oxazepam
Epilepsy

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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: s

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.

Locations(1)

Australia

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ACTRN12611000546954