Clinical trial NCT03402022: Drug Use and Ultra-endurance Race
Official title: Drug Use During a Very Long Distance Mountain Trail: a Study Using Automated Urine Collection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Individuals
Keywords: Sport
competition
ultra-endurance
trail running
doping
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 2923
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy individuals

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: 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.
timeFrame: 18 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: UniversityHospitalGrenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Pierre BOUZAT, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Robach P, Trebes G, Lasne F, Buisson C, Mechin N, Mazzarino M, de la Torre X, Roustit M, Kerivel P, Botre F, Bouzat P. Drug Use on Mont Blanc: A Study Using Automated Urine Collection. PLoS One. 2016 Jun 2;11(6):e0156786. doi: 10.1371/journal.pone.0156786. eCollection 2016.