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 |
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Recruitment Status :
Recruiting
First Posted : November 22, 2019
Last Update Posted : February 17, 2021
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| Tracking Information | |||||||||
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| 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 |
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:
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| Original Primary Outcome Measures |
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:
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| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| 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
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| 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 |
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| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 16 Years to 25 Years (Child, Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| 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 |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Hospices Civils de Lyon | ||||||||
| Study Sponsor | Hospices Civils de Lyon | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Hospices Civils de Lyon | ||||||||
| Verification Date | February 2021 | ||||||||