SkiTox: New Psychoactive Substances in Intoxicated Patients During the Winter Activities

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Recruiting
CT.gov ID
NCT04155281
Collaborator
(none)
100
2
30.2
50
1.7

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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 :
Jan 23, 2020
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jul 30, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. positive urinary sample [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 [baseline]

    Clinical symptoms observed in intoxicated patients

  2. polyintoxication frequency [baseline]

    Percentage of co-intoxications

  3. morbidity of intoxication [baseline and month 1]

    length of stay in hospital

  4. morbidity of intoxication [baseline and month 1]

    Percentage of Intensive Care Unit admissions

  5. incidence of intoxication medical care [day 1]

    names of therapies implemented within 24 hours of admission

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CH Albertville Moutiers Albertville France
2 University Hospital Grenoble Grenoble France

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT04155281
Other Study ID Numbers:
  • 38RC19.214
  • 2019-A02214-53
First Posted:
Nov 7, 2019
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2022