Psychiatric EmergencyDRUGSNCT04173546
Identification of Psychoactive Substance Users in Young Adults (16 to 25 Years Old) Visiting the Emergency Department
An observational study of Psychiatric Emergency and Drug Use, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Adolescence is a time for great physical and psychological change and it's often at that period of life that first use of psychoactive substances occurs. Although addiction is rare in teenagers, psychoactive substances abuse can have serious long-term health consequences on them. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Psychiatric Emergency, Drug Use
- How many people
- 459 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2020to 15 Apr 2021
- 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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Young people aged 16-25 inclusive, admitted to the Medical and Psychiatric Emergency Department (Building N) of the Edouard Herriot Hospital.
Who may be able to join
- All patients aged 16 to 25 admitted at the Medical and Psychiatric Emergency Department.
- For adults: those who will agree to participate in this study
- For Minors from the age of 16: those who will agree to participate and want to exercise their rights by themselves or for whom one parent or legal guardian agrees for their participation.
Who cannot join
- patient who doesn't understand French
- patient under legal protection measures or guardianship
- confused person (GSC < 15)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systematic Screening and Identification of Psychoactive Substances Users in Young Adults (16 to 25 Years Old) Visiting the Emergency Department
Adolescence is a time for great physical and psychological change and it's often at that period of life that first use of psychoactive substances occurs. Although addiction is rare in teenagers, psychoactive substances abuse can have serious long-term health consequences on them. This is therefore a priority for all healthcare providers to identify early use and abuse of drugs in the youth's population.
The addictive process underlies environmental, genetic and individual causes. That is why it is somehow possible to identify individuals at risk based on some common sociological, cultural and environmental risk factors.
Read more
Due to the acute consequences of psychoactive substances abuses, Emergency Departments are main checkpoints for the screening of young drug users. Indeed, one patient out of five admitted in an Emergency Department shows a positive blood alcohol concentration regardless of the reason for their admission. This rate is twice as high as in the overall population. Hence, Emergency Departments are at the front-line for screening, caring, referral and transfer of psychoactive substances users. That is why the Emergency Department is the best place for this study.
In 2004, the special consultations of young consumers were founded in order to deal with these special cases where dependence is not yet established or installed and care has to be adapted to the age. Offering help to this age range represents a real challenge since only 20% of the teenagers come to visit this special consultations on their own initiative. The rest of teenagers are either obliged by their parents or sentenced by a court. The investigators assume that the repetition of care offered to the teenagers by repeated emergency admissions could trigger their own desire to overcome their drug use disorders and visit the Addictionology Department.
- Conditions
- Psychiatric Emergency, Drug Use
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption questionnaire and urinary strips to detect psychoactive substances users
The primary objective of the study is to evaluate the prevalence of psychoactive substances use among young adults, aged 16 to 25, visiting the Emergency Department.
This evaluation will be twofold:
- declarative through a consumption questionnaire (response by Yes or No without score) (whole life, past three months and previous month)
- analytical by means of a urinary screening for recent consumptions (from a few days to a few weeks according to the products) of seven psychoactive substances (Alcohol, tobacco, cannabis, ecstasy, amphetamines, cocaine, morphinics).
Measured: Follow-up time: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start11 Feb 2020
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric EmergencyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélie BERGER-VERGIAT, MD, Principal investigator, Service Addictologie et Psychiatrie des urgences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173546
- Sponsor's protocol ID
- 69HCL18_0974
- Acronym
- DRUGS
- Status last verified
- Apr 2021
- First submitted
- 15 Nov 2019
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Screening and Identification of Psychoactive Substances Users in Young Adults (16 to 25 Years Old) Visiting the Emergency Department
- ClinicalTrials.gov ID
- NCT04173546
- Acronym / sponsor ID
- DRUGS / 69HCL18_0974
- Conditions
- Psychiatric Emergency, Drug Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 22 Nov 2019 (actual)
- 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.
Adolescence is a time for great physical and psychological change and it's often at that period of life that first use of psychoactive substances occurs. Although addiction is rare in teenagers, psychoactive substances abuse can have serious long-term health consequences on them. This is therefore a priority for all healthcare providers to identify early use and abuse of drugs in the youth's population.
The addictive process underlies environmental, genetic and individual causes. That is why it is somehow possible to identify individuals at risk based on some common sociological, cultural and environmental risk factors.
Due to the acute consequences of psychoactive substances abuses, Emergency Departments are main checkpoints for the screening of young drug users. Indeed, one patient out of five admitted in an Emergency Department shows a positive blood alcohol concentration regardless of the reason for their admission. This rate is twice as high as in the overall population. Hence, Emergency Departments are at the front-line for screening, caring, referral and transfer of psychoactive substances users. That is why the Emergency Department is the best place for this study.
In 2004, the special consultations of young consumers were founded in order to deal with these special cases where dependence is not yet established or installed and care has to be adapted to the age. Offering help to this age range represents a real challenge since only 20% of the teenagers come to visit this special consultations on their own initiative. The rest of teenagers are either obliged by their parents or sentenced by a court. The investigators assume that the repetition of care offered to the teenagers by repeated emergency admissions could trigger their own desire to overcome their drug use disorders and visit the Addictionology Department.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Young people aged 16-25 inclusive, admitted to the Medical and Psychiatric Emergency Department (Building N) of the Edouard Herriot Hospital.
Key inclusion criteria (3 listed)
- All patients aged 16 to 25 admitted at the Medical and Psychiatric Emergency Department.
- For adults: those who will agree to participate in this study
- For Minors from the age of 16: those who will agree to participate and want to exercise their rights by themselves or for whom one parent or legal guardian agrees for their participation.
Key exclusion criteria (3 listed)
- patient who doesn't understand French
- patient under legal protection measures or guardianship
- confused person (GSC < 15)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Consumption questionnaire and urinary strips to detect psychoactive substances users
Time frame: Follow-up time: 3 months
The primary objective of the study is to evaluate the prevalence of psychoactive substances use among young adults, aged 16 to 25, visiting the Emergency Department. This evaluation will be twofold: * declarative through a consumption questionnaire (response by Yes or No without score) (whole life, past three months and previous month) * analytical by means of a urinary screening for recent consumptions (from a few days to a few weeks according to the products) of seven psychoactive substances (Alcohol, tobacco, cannabis, ecstasy, amphetamines, cocaine, morphinics).
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 26 Apr 2021.
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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.
Aurélie BERGER-VERGIAT, MD principal investigator
Service Addictologie et Psychiatrie des urgences
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 Psychiatric Emergency and Drug Use, run by Hospices Civils de Lyon 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 3 inclusion and 3 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 26 Apr 2021. 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?
Consumption questionnaire and urinary strips to detect psychoactive substances users (time frame: Follow-up time: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2021.