ACTRN12618000727246招募中2 期
The effect of psychoactive prescription benzodiazepines (alprazolam, temazepam and diazepam) and concomitant alcohol consumption upon performance and ocular activity whilst driving in adults.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
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 40 Years(—)
- 性别
- All
入选标准
- •Male or female, aged 21 to 40 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;
- •Must have normal or corrected-to-normal vision;
- •In good general health as judged by the investigator and research nurse;
- •Non-smoker;
- •Social drinker, who is experienced with consuming two alcoholic drinks on a single occasion, typically in a social setting;
- •Experience with benzodiazepines;
- •Is a regular driver (> 4,000 km/year) with three years of driving with a full driver’s licence;
- •Less than 95kg in weight (due to the weight related dosing of alcohol);
- •Willing to abstain from the following prior to their scheduled visit:
- •oNo food or drinks (except water) within 2 hours prior to testing
- •oNo caffeine-containing products within 12 hours prior to testing
- •oNo alcohol within 24 hours prior to testing
- •oNo drugs/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).
- •oNo driving or riding a bicycle or motorbike from the site
- •oNo driving, riding, operating heavy machinery for 24 hours after leaving the site
- •oNo alcohol, drugs, or medication (unless you have consulted with your doctor) for 24 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 or substance abuse or current illicit drug abuse;
- •History of neurological conditions or previous or current history of psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders;
- •Pregnant, potentially pregnant or lactating;
- •Taking any form of ongoing medication (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne);
- •Unable to participate in scheduled visit, treatment plan, tests and other study procedures according to the protocol;
- •Current participation in any other studies involving investigational or marketed products within 30 days prior to the screening visit;
- •Have previously participated in this study.
研究者
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