Characterising the effect of methamphetamine and alcohol on driving behaviour and performance in healthy volunteers

Swinburne University of Technology0 个研究点目标入组 30 人开始时间: 2018年4月20日最近更新: 2021年1月18日

试验速览

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•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;
•Non-smoker;
•Social drinker, who is experienced with consuming two alcoholic drinks on a single occasion, typically in a social setting;
•Experience with amphetamine-type substances;
•Is a regular driver (> 4,000 km/year) with three years of driving with a full driver’s licence;
•Less than 100kg in weight (due to weight related doses of d-methamphetamine and 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 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 illicit substance use for one week prior to, and for the duration of the trial.
•oNo driving or riding a bicycle or motorbike from the testing site;
•oNo driving, riding, operating heavy machinery for 24 hours after leaving the site
•oNo alcohol, drugs, or medication (unless consulted with doctor) for 24 hours after
•leaving the site.

•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.

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