跳至主要内容
临床试验/NCT03402022
NCT03402022已完成不适用

Drug Use During a Very Long Distance Mountain Trail: a Study Using Automated Urine Collection

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 2,923 人开始时间: 2017年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,923
试验地点
1
主要终点
To measure urinary drug concentrations (in ng/ml) amongst male participants in a very long distance mountain trail, by targeting the molecules most likely used by the runners.

研究概览

简要总结

Hypothesis: To verify whether the use of drugs, in particular performance-enhancing drugs, is prevalent amongst participants in a very long distance mountain trail.

Primary objective : To qualify and quantify drug use amongst participants in a very long distance mountain trail, by targeting the molecules most likely used by the runners.

详细描述

Introduction

very long distance mountain trail which is particularly demanding for the organism. This kind of competition is likely to have an impact on the athlete's health and / or physical integrity. It is assumed that many participants may use medication in an attempt to i) prevent and /or treat medical conditions induced by prolonged muscular exercise, and ii) delay fatigue and improve physical and/or psychological capacities. Beyond ethical and regulatory considerations, such practice in this isolated environment is not without health risks. However, to our knowledge, there is no objective data on medication use during very long distance mountain trails.

Methodology : Individual urine samples from male competitors participating in a very long distance mountain trail and using temporary urinals near the starting line will be collected within three hours before departure, anonymously, blindly, using hidden automated samplers. Simultaneously with automated urine sampling, demographic data (age class, ranking class, geographical area of residence, performance class over the year) will be collected anonymously via an automated system detecting the runners' electronic bibs. The quantification of different classes of drugs in the urine samples will be performed by World Anti-Doping Agency-accredited laboratories using liquid chromatography, mass spectrometry and / or gas chromatography. The classes of molecules sought will be the following: most common non-steroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, stimulants, narcotics, anabolic agents, metabolic modulators, cannabinoids, beta2-agonists, beta-blockers, diuretics, benzodiazepines. A questionnaire about drug use before/during the race and using the randomized response technique (RRT) will be proposed online, anonymously to female and male participant after the competition.

Expected results : drug use is frequent amongst participants in a very long distance mountain trail. Drug use prevalence measured from automated urine collection is higher than that obtained from the RRT questionnaire.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Automated urine collection : male participants starting a very long distance mountain trail.
  • Questionnaire: female and male participants in a very long distance mountain trail.

排除标准

  • 未提供

结局指标

主要结局

To measure urinary drug concentrations (in ng/ml) amongst male participants in a very long distance mountain trail, by targeting the molecules most likely used by the runners.

时间窗: 18 months

* sampling 466 individual urine specimens from male participants in a very long distance mountain trail; * measuring urinary concentrations of drugs belonging to the following classes : nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, stimulants, narcotics, anabolic agents, metabolic modulators, cannabinoids, beta2-agonists, beta-blockers, diuretics, benzodiazepines. Drug concentrations will be determined through liquid chromatography, mass spectrometry and / or gas chromatography, according to the molecules.

次要结局

  • To measure the responses (yes or no) to a questionnaire about drug use, amongst female and male participants in a very long distance mountain trail, by targeting the molecules most likely used by the runners.(6 months)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验