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临床试验/ACTRN12620000499987
ACTRN12620000499987招募中2 期

Effect of acute Methylphenidate (Ritalin®) dose on visual attention, subjective mood assessments and driving performance in healthy volunteers

Swinburne University of Technology0 个研究点目标入组 30 人开始时间: 2020年4月21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
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 45 Years(—)
性别
All

入选标准

  • Male or female, aged 21 to 45 years;
  • Less than 100kg in weight [due to expected metabolism rate of Methylphenidate (Ritalin®), 10mg];
  • 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;
  • Is a regular driver (> 4,000 km/year) with three years of driving with a full driver’s licence;
  • 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 24 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 24 hours after leaving the site
  • o No alcohol, drugs, or medication (unless consulted with 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
  • Currently under administrative or legal supervision.

研究者

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