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New Psychoactive Substances in Intoxicated Patients During the Winter Activities (SKI-Tox)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155281
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : October 21, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
The purpose of this research is to identify the New Psychoactive Substances (NPS) that are responsible for intoxicating patients in ski resort during winter activities.

Condition or disease Intervention/treatment
Acute Intoxication Psychoactive Substance Use Other: urine analysis

Detailed Description:
The New Psychoactive Substances expose to an additional risk of overdose or death due to their potency. These New Psychoactive Substances are used voluntarily by users wishing to test new substances, but also involuntarily because of association (unknowingly users) with more "conventional" drugs such as cocaine or heroin in the self-administered powder. These intoxications are still poorly known and the investigators believe that the identification of New Psychoactive Substances among the drugs consumed, and the association of their consumption with the appearance of a particular symptomatology allow the physician to guide the diagnosis and facilitate the care of future patients.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Consumption of New Psychoactive Substances in Intoxicated Patients During the Winter Activities
Actual Study Start Date : January 23, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
suspicion of intoxication
New Psychoactive Substances research in urine
Other: urine analysis
New Psychoactive Substances research in urine at admission in unit care




Primary Outcome Measures :
  1. positive urinary sample [ Time Frame: Day 0 ]
    proportion of urine samples positive for New Psychoactive Substances and related, among patients suspected of intoxication and from a ski resort, in winter.


Secondary Outcome Measures :
  1. incidence of toxidromes [ Time Frame: baseline ]
    Clinical symptoms observed in intoxicated patients

  2. polyintoxication frequency [ Time Frame: baseline ]
    Percentage of co-intoxications

  3. morbidity of intoxication [ Time Frame: baseline and month 1 ]
    length of stay in hospital

  4. morbidity of intoxication [ Time Frame: baseline and month 1 ]
    Percentage of Intensive Care Unit admissions

  5. incidence of intoxication medical care [ Time Frame: day 1 ]
    names of therapies implemented within 24 hours of admission


Biospecimen Retention:   Samples Without DNA
urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient will be included at admission to hospital. After recording non-opposition to the study, the urinary sample of the medical care will be kept and send to the central lab for analysis and new psychoactive substances research.
Criteria

Inclusion Criteria:

  • Admission to emergency, resuscitation or intensive care departments involved in the study
  • Anamnestic and / or clinical suspicion of acute drug poisoning according to International Classification of Diseases-10 criteria
  • Patient coming from a ski resort from the pre-established list
  • urine sample available as part of the treatment
  • person understanding French or English
  • Non-opposition to the study

Exclusion Criteria:

  • Suspicion of alcohol intoxication alone
  • Suspicion of voluntary drug poisoning
  • Suspicion of intentional intoxication by others
  • Pregnant or lactating women
  • Major mentioned in Articles L1121-6 and 1121-8 of french public health code
  • Patients in the exclusion period of another research involving the human person type 1 or 2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155281


Contacts
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Contact: Michel Mallaret, MD +334 76 76 51 45 mmallaret@chu-grenoble.fr
Contact: Roseline Collomb-Muret +334 76 76 76 92 rcollombmuret@chu-grenoble.fr

Locations
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France
CH Albertville Moutiers Not yet recruiting
Albertville, France
Contact: Damien Venchiarutti, MD    +33479895522    damien.venchiarutti@wanadoo.fr   
Principal Investigator: Damien Venchiarutti         
University Hospital Grenoble Recruiting
Grenoble, France
Contact: Maxime Maignan, MD,PhD       mmaignan@chu-grenoble.fr   
Contact: Roseline Collomb-Muret       rcollombmuret@chu-grenoble.fr   
Principal Investigator: Maxime Maignan, MD, PhD         
Sub-Investigator: Nicolas Terzi, MD, PhD         
Sub-Investigator: Damien Viglino, MD, PhD         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Maxime Maignan, MD, PhD University Hospital, Grenoble
Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04155281    
Other Study ID Numbers: 38RC19.214
2019-A02214-53 ( Other Identifier: ID RCB )
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: October 21, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No