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Identification of Psychoactive Substance Users in Young Adults (16 to 25 Years Old) Visiting the Emergency Department (DRUGS)

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ClinicalTrials.gov Identifier: NCT04173546
Recruitment Status : Recruiting
First Posted : November 22, 2019
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date November 15, 2019
First Posted Date November 22, 2019
Last Update Posted Date February 17, 2021
Actual Study Start Date February 11, 2020
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 6, 2020)
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).
Original Primary Outcome Measures
 (submitted: November 19, 2019)
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 (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).
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Identification of Psychoactive Substance Users in Young Adults (16 to 25 Years Old) Visiting the Emergency Department
Official Title Systematic Screening and Identification of Psychoactive Substances Users in Young Adults (16 to 25 Years Old) Visiting the Emergency Department
Brief 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. 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Urinary strips will determine the 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). The detection of some substances in urine works via measurement of the decomposition products from metabolism: cotinine for tobacco, ethyl glucuronide for alcohol, benzoylecgonine for cocaine. Regarding ecstasy, amphetamines, cannabis and morphinics, the detection is done directly in urines. There are seven reading windows (one for each substance) on the Drug Screen: if a colored strip appears in the reading window it means that the detection is negative, otherwise if there is no strip it is considered as positive
Sampling Method Probability Sample
Study Population Young people aged 16-25 inclusive, admitted to the Medical and Psychiatric Emergency Department (Building N) of the Edouard Herriot Hospital.
Condition
  • Psychiatric Emergency
  • Drug Use
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 19, 2019)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 1, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • patient who doesn't understand French
  • patient under legal protection measures or guardianship
  • confused person (GSC < 15)
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Aurélie BERGER-VERGIAT, MD 04 72 11 91 04 ext +33 aurelie.berger-vergiat@chu-lyon.fr
Contact: Mathieu CHAPPUY, MD 04 72 11 91 04 ext +33 mathieu.chappuy@chu-lyon.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04173546
Other Study ID Numbers 69HCL18_0974
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators
Principal Investigator: Aurélie BERGER-VERGIAT, MD Service Addictologie et Psychiatrie des urgences
PRS Account Hospices Civils de Lyon
Verification Date February 2021