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Completed

NCT Number: NCT04155281

New Psychoactive Substances in Intoxicated Patients During the Winter Activities

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Métropole Savoie (Chaméry), Chambéry, Savoie, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 breastfeeding 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

Treatment and study plan

Urine analysis

Other

New Psychoactive Substances research in urine at admission in unit care

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Consumption of New Psychoactive Substances in Intoxicated Patients During the Winter Activities

Acronym: SkiTox

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 7, 2019
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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