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

August 31, 2020 updated by: Assistance Publique - Hôpitaux de Paris

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont Ferrand, France, 63000
        • CHU Clermont-Ferrand - service de santé publique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
between January and April 2017 and January and April 2018

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of use for each PAS
Time Frame: between January and April 2017 and January and April 2018
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
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
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
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
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
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
between January and April 2017 and January and April 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Mission Interministérielle de Lutte contre les Drogues et les Conduites Addictives - MILDECA
Agence Nationale de sécurité du Médicament

Investigators

  • Principal Investigator: DJEZZAR Samira, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2017

Primary Completion (Actual)

July 23, 2019

Study Completion (Actual)

July 23, 2019

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (Estimate)

November 3, 2016

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UC1602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psychoactive Substances Consumption

Clinical Trials on Online self-administrated and anonymous survey questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe