None listed
Conditions
Brief summary
The primary objectives of this 2-Arm trial are to; 1) further ascertain the effects of various levels of acute alcohol (Arm 1) and alcohol-hangover (Arm 2) on simulated driving performance and cognitive functioning; 2) compare the results of simulated driving performance with findings from a battery of cognitive tests (Schuhfried Vienna Test System) to examine the effectiveness of Schuhfried in evaluating driver performance; and 3) validate the use of a semi-naturalistic research design in measuring the effects of alcohol-hangover. A total of 35 healthy participants, aged 18-40 years will complete this within-subjects crossover trial. Arm 1 of the trial is single-blinded and involves three administrations of alcohol 0.0 g/kg, 0.65 g/kg and 0.85 g/kg across separate sessions to achieve BACs of 0.00%, 0.05% and 0.08%. Alcohol will be Vodka mixed with orange juice in the alcohol conditions. Arm 2 is a trial on alcohol hangover in two phases. Arm 2a follows two visits in Arm 1, placebo and 0.85 g/kg conditions. Further alcohol will be administered after the 0.85 g/kg session. Up to 1.3 g/kg alcohol will be administered accounting for alcohol already consumed. Participants will be assessed the morning following alcohol consumption and after the placebo condition where no alcohol is consumed. Arm 2b of the trial is a semi-naturalistic study design. Participants consume alcohol on a 'normal' night out. Participants will be assessed the morning following alcohol consumption and a night of no alcohol. At all test sessions, participants will complete simulated driving, cognitive measures and questionnaires including perceived performance, willingness to drive and sleep
Interventions
Alcohol is the intervention being assessed across two study Arms. Alcohol will be consumed twice in Arm 1, once in Arm 2a and once in Arm 2b. Overall, participants will attend the testing site on 7 occasions, 6 for testing and 1 screening. Arm 1: This arm involves 3 test sessions where 0.0 g/kg (placebo), 0.6 g/kg and 0.85 g/kg of alcohol will be administered. 2 of these visits will coincide with Arm 2a. This is as follows: i) Arm 1 placebo (0.0 g/kg), followed by Arm 2a (no alcohol administered) ii) Arm 1 involving 0.6 g/kg (no association to Arm 2a) iii) Arm 1 involving 0.85 g/kg, followed by Arm 2a where additional alcohol is administered up to 1.3 g/kg (accounting for alcohol already consumed). Arm 1 visits will be randomized and commence between 4-6 pm. Alcohol will be Absolut brand vodka mixed with original black label orange juice. Participants are allocated 20 minutes to consume alcohol with the exception of the Arm 2a 1.3 g/kg condition where extra time is allowed (see below). Alcohol will be served by a research assistant (with responsible service of alcohol certification), at the instruction of the principle investigator. Alcohol administration will also be supervised by a research nurse. A research assistant and the research nurse will be present to monitor adherence to the intervention. Each visit will separated by no less than 5 days and no more than 14 days. Arm 2a: This Arm involves 2 test sessions: no alcohol and 1.3 g/kg alcohol. The 2 visits follow the Arm 1 visits described above. Participants are allowed up to 2 hours to consume extra beverages in 1.3 g/kg condition with a mandatory 20 minute absorption period to follow. Alcohol will be served by a research assistant. Participants will be monitored by a research assistant and research nurse and are not obliged to consume all allocated beverages. Following administration of the intervention participants will be sent home for the evening (by taxi) before returning to the test site the following morning for the non-hangover (no alcohol) and hangover (1.3 g/kg) test sessions. These sessions will be between 8-11 hrs after alcohol consumption and will be scheduled between 7-11 am. Arm 2b: This Arm occurs after the completion of Arm 1 and 2a and involves 2 visits: no hangover and hangover. Participants will consume alcohol on a normal night out unrestricted, and attend testing the following morning when experiencing a hangover. The no hangover session will follow a night of alcohol abstinence. Test sessions will be scheduled between 7-11 am. Participants will contacted the morning of the test session to ensure they are attending (both sessions) and are feeling well enough to attend (hangover session only). Participant compliance will also be monitored by self-report assessments of hangover severity and BAC readings of 0.00%. Test visits will be randomized and no less than 5 days and no more than 14 days apart.
Sponsors
Study design
Eligibility
Inclusion criteria
Regularly consume alcohol in doses that produce hangover, full or provisional (Level P2) drivers license, and in general good health
Exclusion criteria
Current or history of alcohol/drug abuse or psychiatric disorders, current medically treated liver or renal impairment; regular smokers; if female; pregnant or breast-feeding; use of any medication that may interact with alcohol; weighing >100kg, never experienced a hangover; does not consume alcohol on a single occasion to equate to a BAC of approximately 0.12%; susceptibility to simulator adaptation syndrome