New Psychoactive Substances in Intoxicated Patients During the Winter Activities (SkiTox)

November 28, 2023 updated by: University Hospital, Grenoble

Consumption of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Albertville, France
        • CH Albertville Moutiers
      • Grenoble, France
        • University Hospital Grenoble
    • Savoie
      • Chambéry, Savoie, France, 73000
        • Centre Hospitalier Métropole Savoie (Chaméry)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patient will be included at admission to hospital (Grenoble alpes university hospital, CH Albertville-Moûtiers and Centre Hospitalier Métropole Savoie/Chambéry). After collecting his/her non-opposition to the study, the urine sample of the medical care will be kept and send to the central lab for analysis and dentifation of new psychoactive substances.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of toxidromes
Time Frame: baseline
Clinical symptoms observed in intoxicated patients
baseline
polyintoxication frequency
Time Frame: baseline
Percentage of co-intoxications
baseline
morbidity of intoxication
Time Frame: baseline and month 1
length of stay in hospital
baseline and month 1
morbidity of intoxication
Time Frame: baseline and month 1
Percentage of Intensive Care Unit admissions
baseline and month 1
incidence of intoxication medical care
Time Frame: day 1
names of therapies implemented within 24 hours of admission
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Damien VIGLINO, MD, PhD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2020

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

September 27, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC19.214
  • 2019-A02214-53 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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