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临床试验/ACTRN12618000727246
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.

Swinburne University of Technology0 个研究点目标入组 90 人开始时间: 2018年5月2日最近更新:
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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