Skip to main content
OpenTrials
Completed

NCT Number: NCT03402022

Drug Use and Ultra-endurance Race

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UniversityHospitalGrenoble

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: 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.

Secondary outcomes

  1. 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.

    Time frame: 6 months

    • obtaining a return rate of at least 30% to the anonymous, online questionnaire proposed to the participants after their race.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: Ultra-Trail

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 17, 2018
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.