ACTRN12623001255673招募中2 期
A randomised, placebo-controlled crossover trial examining the biphasic effects of alcohol on ocular parameters during driving in adults who drive regularly (ALC-GAZE)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 21 Years 至 55 Years（—）
- 性别
- All
入选标准
- •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 0.05% with no known adverse reaction [more than 3 standard drinks (female) or 4 standard drinks (male) on single drinking occasion]
- •- Normal or corrected-to-normal vision
- •- 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. This limit is critical for participant safety. In this study, alcohol delivery is based on weight, and by defining this limit, we avoid overdosing and hence minimise potential health concerns
- •- Willing to abstain from the following prior to their scheduled visit:
- •- No food or drinks (except water) within 2 hours prior to testing
- •- No caffeine-containing products within 12 hours prior to testing
- •- No alcohol within 24 hours prior to testing
- •- 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)
- •- No illicit substance use for one week prior to, and for the duration of the trial.
- •- No driving or riding a bicycle or motorbike to and from the testing site
- •- No driving, riding, operating heavy machinery for 12 hours after leaving the site
- •- No alcohol, illicit drugs, or medication (unless consulted with a doctor) for 12 hours after leaving the site.
排除标准
- •- 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 (BDI score of greater than or equal to 20)
- •- Severe current anxiety (BAI 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.
研究者
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