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

Plain Language Summary

Simplified for easier understanding

This study examines how common prescription medicines — such as pain relievers and anti-anxiety drugs — affect driving performance, both on their own and when combined with alcohol. Participants will use a driving simulator after taking these medications, so researchers can safely measure any effects on reaction time, attention, and driving skill. The goal is to generate evidence that helps doctors advise patients about driving safely while on medication. You may be eligible if: - You are between 25 and 50 years of age - You hold a current driver's licence - You are able to understand English and give written informed consent - You drink alcohol occasionally (you are not alcohol-naive) You may NOT be eligible if: - You have never consumed alcohol in your life - You have a history of dependence on alcohol or any drug (other than tobacco) - You have a significant medical or psychiatric condition that could affect your safety in the study - You are currently taking any prescription medication (other than contraception) that could interact with alcohol, codeine, or oxazepam - You have epilepsy Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Print for Your Doctor Check Your Eligibility

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12611000546954