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French Study on COgnitive Enhancement and Consumption of Psychoactive Substances Among Youth Students (ENQUETE-COSYS)

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ClinicalTrials.gov Identifier: NCT02954679
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : May 5, 2017
Sponsor:
Collaborators:
Mission Interministérielle de Lutte contre les Drogues et les Conduites Addictives – MILDECA
Agence Nationale de sécurité du Médicament
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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 (MPH) and modafinil in improvement of cognitive performance).

Condition or disease Intervention/treatment
Psychoactive Substances Consumption Substance-related Disorder Off Label-use Cognitive Enhancement Other: Online self-administrated and anonymous survey questionnaire

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.


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Study Type : Observational
Estimated Enrollment : 30000 participants
Observational Model: Other
Time Perspective: Prospective
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)
Actual Study Start Date : January 23, 2017
Estimated Primary Completion Date : July 23, 2019
Estimated Study Completion Date : July 23, 2019

Intervention Details:
  • Other: Online self-administrated and anonymous survey questionnaire
    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.


Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Rate of use for each PAS [ Time Frame: between January and April 2017 and January and April 2018 ]
  2. Motives of consumption : hedonic (festive, recreational, experimental, boredom management) [ Time Frame: between January and April 2017 and January and April 2018 ]
  3. Motives of consumption : performance (creativity, sports, cognition) [ Time Frame: between January and April 2017 and January and April 2018 ]
  4. Motives of consumption : therapeutic (sleep disorder, anxiety, sadness, weight control) [ Time Frame: between January and April 2017 and January and April 2018 ]
  5. Motives of consumption : social (making friends, being noticed, assertion of identity)control) [ Time Frame: between January and April 2017 and January and April 2018 ]
  6. 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 ]
  7. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • Subjects aged more than 18 years old
  • Students (University, BTS, Grandes Ecoles, IFSI, preparatory classes) registered in the ongoing year

Exclusion Criteria:

- Minor subjects


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954679


Contacts
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Contact: DJEZZAR Samira, MD 33 (1) 40054962 samira.djezzar@aphp.fr
Contact: BATISSE Anne, MD 33 (1) 40054962 anne.batisse@aphp.fr

Locations
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France
CHU Clermont-Ferrand - service de santé publique Recruiting
Clermont Ferrand, France, 63000
Contact: Laurent GERBAUD, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Mission Interministérielle de Lutte contre les Drogues et les Conduites Addictives – MILDECA
Agence Nationale de sécurité du Médicament
Investigators
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Principal Investigator: DJEZZAR Samira Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02954679     History of Changes
Other Study ID Numbers: UC1602
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Substance-related Disorder
Psychoactive Substances Consumption
Off label-use
Cognitive Enhancement
Students
Doping
Stimulants
Drug abuse
Methylphenidate
Addictovigilance
CEIP

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders