Psychoactive Drug Uses Among Medical and Pharmacy Students (PSYCHO'ACT)

May 6, 2022 updated by: University Hospital, Grenoble
Drug addiction to psychoactive substances, widely consumed in France, represents a major public health issue. The three main motivations identified for the consumption of psychostimulants would be self-medication, the party aspect and the improvement of school performance. Students of medicine and pharmacy are a population exposed to academic and professional stress, vulnerable to health problems and psycho-social disorders (anxiety, depression), with direct access to many drugs at their workplace. Almost a third of these students declared to consume these products to improve their cognitive performance, while a recent study showed that they take them instead to manage their stress and sleep. However, no study has characterized all the different uses of psychoactive drugs (PAD) in this population, nor the motivations for consumption, while an analysis of motives would help to develop better screening and prevention strategies. The main objective of the research is to characterize the motivations for PAD consumption among students of medicine and pharmacy in France. The most represented motives will be analyzed on the questionnaire of motivations for consumption (threshold frequency ≥20%). The secondary objectives are to identify the risk factors linked to the individual, to the environment and to drugs in students with PAD use disorders regardless of their motivation and in those using to improve their performance.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1930

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
      • Grenoble, France, 38043
        • Grenoble_Alpes UniversityHospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

medical and pharmacy students, from the 2nd to the 6th year, in France

Description

Inclusion Criteria:

  • Being of legal age
  • Studying medicine or pharmacy in France from the 2nd to the 6th year
  • Have read the newsletter and validated its no objection
  • Have answered all the questions
  • Validate the return of the questionnaire

Exclusion Criteria:

  • partial filling of the online questionnaire

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The main objective of the research is to characterize the motivations for psychoactive drugs consumption among medical and pharmacy students in France.
Time Frame: two months

frequency of the most represented items concerning the main palatability drug on the Consumption Motivation Screening Questionnaire (frequency threshold considered ≥ 20%).

(the minimum value of the questionnaire: 0 motivation of consumption; the maximum value: 110 motivations of consumption, higher scores mean a more severe addiction)
two months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
In students with a psychoactive drug use disorder whatever their motivations, identify the risk factors related to the individual (anxiety)
Time Frame: two months
assessment the intensity of anxiety on the Hospital Anxiety and Depression scale (the minimum value of the scale : 0 for Anxiety, 0 for Depression; the maximum value: 21 for Anxiety, 21 for depression; higher scores mean a worse outcome)
two months
In students with a psychoactive drug use disorder whatever their motivations, identify the risk factors related to the individual (depression)
Time Frame: two months
assessment the intensity of depression on the Hospital Anxiety and Depression scale (the minimum value of the scale : 0 for Anxiety, 0 for Depression; the maximum value: 21 for Anxiety, 21 for depression; higher scores mean a worse outcome)
two months
In students with a psychoactive drug use disorder whatever their motivations, identify the risk factors related to the environment
Time Frame: two months
family psychiatric history Psycho'act questionnaire
two months
In students with a psychoactive drug use disorder whatever their motivations, identify the risk factors related to drugs.
Time Frame: two months
assessment of the intensity of the psychoactive drug use disorder with the Addictive Intensity Evaluation Questionnaire (the minimum value of the questionnaire : 14; the maximum value: 98; higher scores mean a worse outcome)
two months
In students with psychoactive drug use disorder for doping purposes, identify risk factors related to the individual (anxiety)
Time Frame: two months
assessment the intensity of anxiety on the Hospital Anxiety and Depression scale (the minimum value of the scale : 0 for Anxiety, 0 for Depression; the maximum value: 21 for Anxiety, 21 for depression; higher scores mean a worse outcome)
two months
In students with psychoactive drug use disorder for doping purposes, identify risk factors related to the individual (depression)
Time Frame: two months
assessment the intensity of depression on the Hospital Anxiety and Depression scale (the minimum value of the scale : 0 for Anxiety, 0 for Depression; the maximum value: 21 for Anxiety, 21 for depression; higher scores mean a worse outcome)
two months
In students with psychoactive drug use disorder for doping purposes, identify risk factors related to the environment
Time Frame: two months
family psychiatric history Psycho'act questionnaire
two months
In students with psychoactive drug use disorder for doping purposes, identify risk factors related to drugs.
Time Frame: two months
assessment of the intensity of the psychoactive drug use disorder with the Addictive Intensity Evaluation Questionnaire (the minimum value of the questionnaire : 14; the maximum value: 98; higher scores mean a worse outcome)
two months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 38RC20.161
  • 2020-A01352-37 (Other Identifier: ID RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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