A randomised, placebo-controlled crossover trial examining the biphasic effects of two doses of alcohol on ocular parameters of adults who drive regularly during simulated driving (ALC-GAZE).

Swinburne University of Technology0 个研究点目标入组 30 人开始时间: 2023年5月19日最近更新: 2024年8月5日

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•Male or female, aged 21 to 55 years
•Willing and able to provide written informed consent
•Understands and is willing and able to comply with all study procedures
•Fluent in written and spoken English
•Previous history of alcohol consumption in a single drinking session to an estimated BAC of 0.08% with no known adverse reaction [more than 5 standard drinks (female) or 6 standard drinks (male) on single drinking occasion]
•Must have normal or corrected-to-normal vision
•Is a regular driver (>50km/week) with three years of driving with a full Australian or International driver’s licence (no ‘P-Plate’ drivers).
•Weight under 100kg
•Willing to abstain from the following prior to their scheduled visit:
•o No food or drinks (except water) within 2 hours prior to testing
•o No caffeine-containing products within 12 hours prior to testing
•o No alcohol within 12 hours prior to testing
•o No medication for at least 1 week prior to testing (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne)
•o No illicit substance use for one week prior to, and for the duration of the trial.
•o No driving or riding a bicycle or motorbike from the testing site
•o No driving, riding, operating heavy machinery for 12 hours after leaving the site
•o No alcohol, illicit drugs, or medication (unless consulted with doctor) for 12 hours after leaving the site.

•Unable to understand or comply with testing procedures
•Inability to speak or read English
•History of drug abuse or dependence or current illicit drug abuse
•Current neurological, psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders
•Pregnant or lactating
•Taking any form of medication within one week of admission (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study
•Unable to participate in scheduled visit, treatment plan, tests and other study procedures according to the protocol
•Weight over 100kg
•Moderate-severe current depression (Beck Depression Inventory score of greater than or equal to 20)
•Severe current anxiety (Beck Anxiety Inventory score greater than or equal to 16)
•Current participation in any other studies involving investigational or marketed products within 30 days prior to the screening visit;
•Currently under administrative or legal supervision.

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