Psychoactive Substances ConsumptionENQUETE-COSYSNCT02954679
French Study on COgnitive Enhancement and Consumption of Psychoactive Substances Among Youth Students
An observational study of Psychoactive Substances Consumption and Substance-related Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This descriptive and declarative study will help to find out consumption rates, all psychoactive substances taken together, among 18-25 year olds. More specifically, it will allow assessment of the extent of the cognitive enhancement phenomenon among students in France (including study of misuse of methylphenidate… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychoactive Substances Consumption, Substance-related Disorder, Off Label-use
- What is being tested?
- Online self-administrated and anonymous survey questionnaire
- How many people
- 30,000 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2017to 23 Jul 2019
- 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Students 18-25 year olds in Faculties of Sciences and Technics of Physical and Sports Activities (UFR STAPS) are involved in the study, the issue of doping in Sports will also be addressed.
Who may be able to join
- Subjects aged more than 18 years old
- Students (University, BTS, Grandes Ecoles, IFSI, preparatory classes) registered in the ongoing year
Who cannot join
- Minor subjects
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Clermont-Ferrand - service de santé publique
Clermont-Ferrand, 63000
About this study
Official title: French Study on COgnitive Enhancement and Consumption of Psychoactive Substances Among Youth Students (Enquête Nationale Sur le Dopage Intellectuel et Les Consommations de Substances Psychoactives Chez Les Jeunes étudiants)
This descriptive and declarative study will help to find out consumption rates, all psychoactive substances taken together, among 18-25 year olds. More specifically, it will allow assessment of the extent of the cognitive enhancement phenomenon among students in France (including study of misuse of methylphenidate (MPH) and modafinil in improvement of cognitive performance).
Read the detailed description
This descriptive and declarative study will help to find out consumption rates, among 18-25 year olds, all psychoactive substances (PAS) taken together. More specifically, it will allow assessment of the extent of the cognitive enhancement phenomenon among students in France (including study of misuse of methylphenidate (MPH) and modafinil, two drugs diverted from their indications for improvement of cognitive performance).
Since Faculties of Sciences and Technics of Physical and Sports Activities (UFR STAPS) are involved in the study, the issue of doping in Sports will also be addressed.
The main aim of this national study will be to assess for two successive academic years the proportion and motives of consumption of PAS as part of cognitive enhancement among students in real life.
Secondary aims will be: assessing consumption of PAS and desired effects when such consumption beyond cognitive enhancement (experimental, recreational, abusive or therapeutic use) but also comparing PAS uses in terms of a variety of characteristics (sex, age, field, year of study) and finally to consider more broadly the health of students in a doping behavior (impact of the use of products on health, whether cognitive enhancement is found to be ethically acceptable or not).
The study will be conducted during a period of 3 years, between September 2016 and September 2019, according to a standardized methodology identical in every school involved and a procedure based on an online self-administrated and anonymous survey questionnaire. The questionnaire, elaborated on Limesurvey®, will be available for two successive academic years for all students aged more than 18 years old. It is set up and hosted on a secured high-capacity web server via the website of AP-HP.
The study will also search to assess the level of representation of the sample of respondents regarding the general population of students. Various criteria: the proportion of subjects by field, the proportion of respondents by study year and the sex ratio will be compared to data of general statistics from the Ministry of Research and Higher Education. A representative sample will allow us to assimilate our respondents to the general population of students and estimate the prevalence of PAS consumption among students.
METHODS
For each product, a descriptive analysis of frequency will be done (consumption pattern, consumer's opinion, feeling of dependency, efficacy of the product). For those most frequently used, complementary analysis will be done in order to identify particular profiles.
On the statistical level, univariate analysis will be performed using the Chi-square test and analysis of variance. Then, multivariate analysis will allow us to study independent factors such as age and study year for instance.
The number of respondents expected is approximately 30 000. The sample will also allow us to identify factors associated with PAS consumption (MPH or modafinil particularly) by multivariate modeling using a "split" of the sample procedure with one half used for the construction of the model and the other for its validation.
- Conditions
- Psychoactive Substances Consumption, Substance-related Disorder, Off Label-use, Cognitive Enhancement
- Being tested
- Online self-administrated and anonymous survey questionnaire
- Keywords
- Psychoactive Substances Consumption, Substance-related Disorder, Off label-use, Cognitive Enhancement, Students, Doping, Stimulants, Drug abuse, Methylphenidate, Addictovigilance, CEIP
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online self-administrated and anonymous survey questionnaireOther
The study will be conducted during a period of 3 years, between September 2016 and September 2019, according to a standardized methodology identical in every school involved and a procedure based on an online self-administrated and anonymous survey questionnaire. The questionnaire, elaborated on Limesurvey®, will be available for two successive academic years for all students aged more than 18 years old.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of PAS use for the purpose of cognitive enhancement among students since the beginning of the school year, depending on the school
Measured: between January and April 2017 and January and April 2018
Secondary outcomes (7)
Rate of use for each PAS
Measured: between January and April 2017 and January and April 2018
Motives of consumption : hedonic (festive, recreational, experimental, boredom management)
Measured: between January and April 2017 and January and April 2018
Motives of consumption : performance (creativity, sports, cognition)
Measured: between January and April 2017 and January and April 2018
Motives of consumption : therapeutic (sleep disorder, anxiety, sadness, weight control)
Measured: between January and April 2017 and January and April 2018
Motives of consumption : social (making friends, being noticed, assertion of identity)control)
Measured: between January and April 2017 and January and April 2018
Consumption pattern (dose, route of administration, frequency, way to obtain, associated drugs, period)
Measured: between January and April 2017 and January and April 2018
Comparison PAS uses in terms of a variety of characteristics of subjects (sex, age, sector, year of study).
Measured: between January and April 2017 and January and April 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study start23 Jan 2017
- Primary completion23 Jul 2019
- Study completion23 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychoactive Substances ConsumptionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Mission Interministérielle de Lutte contre les Drogues et les Conduites Addictives - MILDECA, Agence Nationale de sécurité du Médicament
- Responsible party
- Sponsor
- Investigators
- DJEZZAR Samira, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954679
- Sponsor's protocol ID
- UC1602
- Acronym
- ENQUETE-COSYS
- Status last verified
- Apr 2017
- First submitted
- 2 Nov 2016
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Batisse A, Leger S, Vicaut E, Gerbaud L, Djezzar S. COgnitive enhancement and consumption of psychoactive Substances among Youth Students (COSYS): a cross-sectional study in France. Public Health. 2021 May;194:75-78. doi: 10.1016/j.puhe.2021.02.036. Epub 2021 Apr 14.
PubMed 33865150
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Study on COgnitive Enhancement and Consumption of Psychoactive Substances Among Youth Students (Enquête Nationale Sur le Dopage Intellectuel et Les Consommations de Substances Psychoactives Chez Les Jeunes étudiants)
- ClinicalTrials.gov ID
- NCT02954679
- Acronym / sponsor ID
- ENQUETE-COSYS / UC1602
- Conditions
- Psychoactive Substances Consumption, Substance-related Disorder, Off Label-use, Cognitive Enhancement
- Keywords
- Psychoactive Substances Consumption, Substance-related Disorder, Off label-use, Cognitive Enhancement, Students, Doping, Stimulants, Drug abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,000 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Mission Interministérielle de Lutte contre les Drogues et les Conduites Addictives - MILDECA, Agence Nationale de sécurité du Médicament
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 23 Jul 2019 (actual)
- Study completion
- 23 Jul 2019 (actual)
- First posted
- 3 Nov 2016 (estimated)
- 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.
This descriptive and declarative study will help to find out consumption rates, all psychoactive substances taken together, among 18-25 year olds. More specifically, it will allow assessment of the extent of the cognitive enhancement phenomenon among students in France (including study of misuse of methylphenidate (MPH) and modafinil in improvement of cognitive performance).
Detailed description
This descriptive and declarative study will help to find out consumption rates, among 18-25 year olds, all psychoactive substances (PAS) taken together. More specifically, it will allow assessment of the extent of the cognitive enhancement phenomenon among students in France (including study of misuse of methylphenidate (MPH) and modafinil, two drugs diverted from their indications for improvement of cognitive performance).
Since Faculties of Sciences and Technics of Physical and Sports Activities (UFR STAPS) are involved in the study, the issue of doping in Sports will also be addressed.
The main aim of this national study will be to assess for two successive academic years the proportion and motives of consumption of PAS as part of cognitive enhancement among students in real life.
Secondary aims will be: assessing consumption of PAS and desired effects when such consumption beyond cognitive enhancement (experimental, recreational, abusive or therapeutic use) but also comparing PAS uses in terms of a variety of characteristics (sex, age, field, year of study) and finally to consider more broadly the health of students in a doping behavior (impact of the use of products on health, whether cognitive enhancement is found to be ethically acceptable or not).
The study will be conducted during a period of 3 years, between September 2016 and September 2019, according to a standardized methodology identical in every school involved and a procedure based on an online self-administrated and anonymous survey questionnaire. The questionnaire, elaborated on Limesurvey®, will be available for two successive academic years for all students aged more than 18 years old. It is set up and hosted on a secured high-capacity web server via the website of AP-HP.
The study will also search to assess the level of representation of the sample of respondents regarding the general population of students. Various criteria: the proportion of subjects by field, the proportion of respondents by study year and the sex ratio will be compared to data of general statistics from the Ministry of Research and Higher Education. A representative sample will allow us to assimilate our respondents to the general population of students and estimate the prevalence of PAS consumption among students.
METHODS
For each product, a descriptive analysis of frequency will be done (consumption pattern, consumer's opinion, feeling of dependency, efficacy of the product). For those most frequently used, complementary analysis will be done in order to identify particular profiles.
On the statistical level, univariate analysis will be performed using the Chi-square test and analysis of variance. Then, multivariate analysis will allow us to study independent factors such as age and study year for instance.
The number of respondents expected is approximately 30 000. The sample will also allow us to identify factors associated with PAS consumption (MPH or modafinil particularly) by multivariate modeling using a "split" of the sample procedure with one half used for the construction of the model and the other for its validation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Students 18-25 year olds in Faculties of Sciences and Technics of Physical and Sports Activities (UFR STAPS) are involved in the study, the issue of doping in Sports will also be addressed.
Key inclusion criteria (2 listed)
- Subjects aged more than 18 years old
- Students (University, BTS, Grandes Ecoles, IFSI, preparatory classes) registered in the ongoing year
Key exclusion criteria (1 listed)
- Minor subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online self-administrated and anonymous survey questionnaireThe study will be conducted during a period of 3 years, between September 2016 and September 2019, according to a standardized methodology identical in every school involved and a procedure based on an online self-administrated and anonymous survey questionnaire. The questionnaire, elaborated on Limesurvey®, will be available for two successive academic years for all students aged more than 18 years old. | Other | – |
Primary outcome
Rate of PAS use for the purpose of cognitive enhancement among students since the beginning of the school year, depending on the school
Time frame: between January and April 2017 and January and April 2018
7 secondary outcomes
Rate of use for each PAS
Time frame: between January and April 2017 and January and April 2018
Motives of consumption : hedonic (festive, recreational, experimental, boredom management)
Time frame: between January and April 2017 and January and April 2018
Motives of consumption : performance (creativity, sports, cognition)
Time frame: between January and April 2017 and January and April 2018
Motives of consumption : therapeutic (sleep disorder, anxiety, sadness, weight control)
Time frame: between January and April 2017 and January and April 2018
Motives of consumption : social (making friends, being noticed, assertion of identity)control)
Time frame: between January and April 2017 and January and April 2018
Consumption pattern (dose, route of administration, frequency, way to obtain, associated drugs, period)
Time frame: between January and April 2017 and January and April 2018
Comparison PAS uses in terms of a variety of characteristics of subjects (sex, age, sector, year of study).
Time frame: between January and April 2017 and January and April 2018
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 1 Sep 2020.
- Derived from this study: PubMed 33865150Batisse A, Leger S, Vicaut E, Gerbaud L, Djezzar S. COgnitive enhancement and consumption of psychoactive Substances among Youth Students (COSYS): a cross-sectional study in France. Public Health. 2021 May;194:75-78. doi: 10.1016/j.puhe.2021.02.036. Epub 2021 Apr 14.
- Individual participant dataSharing planned: No
Related trials for Psychoactive Substances Consumption
RecruitingObservational study
AlcoTail - Implementation of Tailored Interventions
Alcohol Consumption, Psychoactive Substance Use
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.
DJEZZAR Samira principal investigator
Assistance Publique - Hôpitaux de Paris
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 Psychoactive Substances Consumption and Substance-related Disorder, run by Assistance Publique - Hôpitaux de Paris 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 1 Sep 2020. 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?
Rate of PAS use for the purpose of cognitive enhancement among students since the beginning of the school year, depending on the school (time frame: between January and April 2017 and January and April 2018). 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 NCT02954679, which also lists 1 linked publication.
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 1 Sep 2020.