Healthy IndividualsUltra-TrailNCT03402022
Drug Use and Ultra-endurance Race
An observational study of Healthy Individuals, run by University Hospital, Grenoble at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- How many people
- 2,923 participants
- Where
- 1 siteFrance
- Study dates
- 30 Aug 2017to 15 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuals
Who may be able to join
- Automated urine collection : male participants starting a very long distance mountain trail.
- Questionnaire: female and male participants in a very long distance mountain trail.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Use During a Very Long Distance Mountain Trail: a Study Using Automated Urine Collection
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.
Read the 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.
- Conditions
- Healthy Individuals
- Keywords
- Sport, competition, ultra-endurance, trail running, doping
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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.
Measured: 18 months
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.
- obtaining a return rate of at least 30% to the anonymous, online questionnaire proposed to the participants after their race.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start30 Aug 2017
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,923 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre BOUZAT, Dr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402022
- Sponsor's protocol ID
- 38RC17.049
- Other IDs
- 2017-A00484-49
- Acronym
- Ultra-Trail
- Status last verified
- Jan 2018
- First submitted
- 15 Dec 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Hon O, Kuipers H, van Bottenburg M. Prevalence of doping use in elite sports: a review of numbers and methods. Sports Med. 2015 Jan;45(1):57-69. doi: 10.1007/s40279-014-0247-x.
PubMed 25169441Dietz P, Ulrich R, Dalaker R, Striegel H, Franke AG, Lieb K, Simon P. Associations between physical and cognitive doping--a cross-sectional study in 2.997 triathletes. PLoS One. 2013 Nov 13;8(11):e78702. doi: 10.1371/journal.pone.0078702. eCollection 2013.
PubMed 24236038McAnulty S, McAnulty L, Nieman D, Morrow J, Dumke C, Henson D. Effect of NSAID on muscle injury and oxidative stress. Int J Sports Med. 2007 Nov;28(11):909-15. doi: 10.1055/s-2007-964966. Epub 2007 May 31.
PubMed 17541866Millet GY, Banfi JC, Kerherve H, Morin JB, Vincent L, Estrade C, Geyssant A, Feasson L. Physiological and biological factors associated with a 24 h treadmill ultra-marathon performance. Scand J Med Sci Sports. 2011 Feb;21(1):54-61. doi: 10.1111/j.1600-0838.2009.01001.x.
PubMed 19883385Robach 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.
PubMed 27253728Robach P, Trebes G, Buisson C, Mechin N, Mazzarino M, Garribba F, Roustit M, Quesada JL, Lefevre B, Giardini G, DE Seigneux S, Botre F, Bouzat P. Prevalence of Drug Use in Ultraendurance Athletes. Med Sci Sports Exerc. 2024 May 1;56(5):828-838. doi: 10.1249/MSS.0000000000003374. Epub 2024 Jan 18.
PubMed 38233983
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use During a Very Long Distance Mountain Trail: a Study Using Automated Urine Collection
- ClinicalTrials.gov ID
- NCT03402022
- Acronym / sponsor ID
- Ultra-Trail / 38RC17.049
- Conditions
- Healthy Individuals
- Keywords
- Sport, competition, ultra-endurance, trail running, doping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,923 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals
Key inclusion criteria (2 listed)
- Automated urine collection : male participants starting a very long distance mountain trail.
- Questionnaire: female and male participants in a very long distance mountain trail.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Background: PubMed 25169441de Hon O, Kuipers H, van Bottenburg M. Prevalence of doping use in elite sports: a review of numbers and methods. Sports Med. 2015 Jan;45(1):57-69. doi: 10.1007/s40279-014-0247-x.
- Background: PubMed 24236038Dietz P, Ulrich R, Dalaker R, Striegel H, Franke AG, Lieb K, Simon P. Associations between physical and cognitive doping--a cross-sectional study in 2.997 triathletes. PLoS One. 2013 Nov 13;8(11):e78702. doi: 10.1371/journal.pone.0078702. eCollection 2013.
- Background: PubMed 17541866McAnulty S, McAnulty L, Nieman D, Morrow J, Dumke C, Henson D. Effect of NSAID on muscle injury and oxidative stress. Int J Sports Med. 2007 Nov;28(11):909-15. doi: 10.1055/s-2007-964966. Epub 2007 May 31.
- Background: PubMed 19883385Millet GY, Banfi JC, Kerherve H, Morin JB, Vincent L, Estrade C, Geyssant A, Feasson L. Physiological and biological factors associated with a 24 h treadmill ultra-marathon performance. Scand J Med Sci Sports. 2011 Feb;21(1):54-61. doi: 10.1111/j.1600-0838.2009.01001.x.
- Background: PubMed 27253728Robach 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.
- Derived from this study: PubMed 38233983Robach P, Trebes G, Buisson C, Mechin N, Mazzarino M, Garribba F, Roustit M, Quesada JL, Lefevre B, Giardini G, DE Seigneux S, Botre F, Bouzat P. Prevalence of Drug Use in Ultraendurance Athletes. Med Sci Sports Exerc. 2024 May 1;56(5):828-838. doi: 10.1249/MSS.0000000000003374. Epub 2024 Jan 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre BOUZAT, Dr principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Individuals, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03402022, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.