NCT02954679

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 23, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2019

Completed
Last Updated

September 1, 2020

Status Verified

April 1, 2017

Enrollment Period

2.5 years

First QC Date

November 2, 2016

Last Update Submit

August 31, 2020

Conditions

Psychoactive Substances ConsumptionSubstance-related DisorderOff Label-useCognitive Enhancement

Keywords

Psychoactive Substances ConsumptionSubstance-related DisorderOff label-useCognitive EnhancementStudentsDopingStimulantsDrug abuseMethylphenidateAddictovigilanceCEIP

Outcome Measures

Primary Outcomes (1)

  • Rate of PAS use for the purpose of cognitive enhancement among students since the beginning of the school year, depending on the school

    between January and April 2017 and January and April 2018

Secondary Outcomes (7)

  • Rate of use for each PAS

    between January and April 2017 and January and April 2018

  • Motives of consumption : hedonic (festive, recreational, experimental, boredom management)

    between January and April 2017 and January and April 2018

  • Motives of consumption : performance (creativity, sports, cognition)

    between January and April 2017 and January and April 2018

  • Motives of consumption : therapeutic (sleep disorder, anxiety, sadness, weight control)

    between January and April 2017 and January and April 2018

  • Motives of consumption : social (making friends, being noticed, assertion of identity)control)

    between January and April 2017 and January and April 2018

  • +2 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • \- Minor subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand - service de santé publique

Clermont-Ferrand, 63000, France

Location

Related Publications (1)

  • 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.

    PMID: 33865150DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • DJEZZAR Samira

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 3, 2016

Study Start

January 23, 2017

Primary Completion

July 23, 2019

Study Completion

July 23, 2019

Last Updated

September 1, 2020

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)