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CompletedNCT04155281SkiToxUpdated Nov 29, 2023

New Psychoactive Substances in Intoxicated Patients During the Winter Activities

An observational study in Acute Intoxication and Psychoactive Substance Use, sponsored by University Hospital, Grenoble. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
87
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Intoxication
  • Psychoactive Substance Use

Keywords

  • Intoxication; Psychoactive Substance ; Ski
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's enrollment of 87 is below the median of 250 across 296 observational studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
87 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • suspicion of intoxication

    New Psychoactive Substances research in urine

    Other: urine analysis

Interventions

  • Otherurine analysis

    New Psychoactive Substances research in urine at admission in unit care

06

What researchers measure

Primary outcomes

  1. positive urinary sample

    proportion of urine samples positive for New Psychoactive Substances and related, among patients suspected of intoxication and from a ski resort, in winter.

    Time frame: Day 0

Secondary outcomes

  1. incidence of toxidromes

    Clinical symptoms observed in intoxicated patients

    Time frame: baseline

  2. polyintoxication frequency

    Percentage of co-intoxications

    Time frame: baseline

  3. morbidity of intoxication

    length of stay in hospital

    Time frame: baseline and month 1

  4. morbidity of intoxication

    Percentage of Intensive Care Unit admissions

    Time frame: baseline and month 1

  5. incidence of intoxication medical care

    names of therapies implemented within 24 hours of admission

    Time frame: day 1

07

Study locations

3 sites
  • Centre Hospitalier Métropole Savoie (Chaméry)
    Chambéry, Savoie 73000, France
  • CH Albertville Moutiers
    Albertville, France
  • University Hospital Grenoble
    Grenoble, France
08

References and documents

Publications

  • Rivera JV, Vance EG, Rushton WF, Arnold JK. Novel Psychoactive Substances and Trends of Abuse. Crit Care Nurs Q. 2017 Oct/Dec;40(4):374-382. doi: 10.1097/CNQ.0000000000000174. PubMed 28834859 ↗
  • Yang F-S, Chen C-J, Lin Y-C. "Zombie" Outbreak Caused by Synthetic Cannabinoid. N Engl J Med. 2017 Apr 20;376(16):1596-7. doi: 10.1056/NEJMc1701936. No abstract available. PubMed 28425277 ↗
  • Frank RG, Pollack HA. Addressing the Fentanyl Threat to Public Health. N Engl J Med. 2017 Feb 16;376(7):605-607. doi: 10.1056/NEJMp1615145. No abstract available. PubMed 28199808 ↗
  • Khaled SM, Hughes E, Bressington D, Zolezzi M, Radwan A, Badnapurkar A, Gray R. The prevalence of novel psychoactive substances (NPS) use in non-clinical populations: a systematic review protocol. Syst Rev. 2016 Nov 21;5(1):195. doi: 10.1186/s13643-016-0375-5. PubMed 27871332 ↗
  • Kunst LE, Gebhardt WA. Prevalence and Psychosocial Correlates of Party-Drug Use and Associated Problems among University Students in the Netherlands. Subst Use Misuse. 2018 Oct 15;53(12):2077-2088. doi: 10.1080/10826084.2018.1455700. Epub 2018 Apr 18. PubMed 29668345 ↗
  • Palamar JJ, Barratt MJ, Ferris JA, Winstock AR. Correlates of new psychoactive substance use among a self-selected sample of nightclub attendees in the United States. Am J Addict. 2016 Aug;25(5):400-7. doi: 10.1111/ajad.12403. Epub 2016 Jul 15. PubMed 27419383 ↗
  • Ridpath A, Driver CR, Nolan ML, Karpati A, Kass D, Paone D, Jakubowski A, Hoffman RS, Nelson LS, Kunins HV; Centers for Disease Control and Prevention (CDC). Illnesses and deaths among persons attending an electronic dance-music festival - New York City, 2013. MMWR Morb Mortal Wkly Rep. 2014 Dec 19;63(50):1195-8. PubMed 25522087 ↗
  • Fox J, Smith A, Yale A, Chow C, Alaswad E, Cushing T, Monte AA. Drugs of Abuse and Novel Psychoactive Substances at Outdoor Music Festivals in Colorado. Subst Use Misuse. 2018 Jun 7;53(7):1203-1211. doi: 10.1080/10826084.2017.1400067. Epub 2017 Nov 17. PubMed 29148866 ↗
  • Liakoni E, Dolder PC, Rentsch KM, Liechti ME. Presentations due to acute toxicity of psychoactive substances in an urban emergency department in Switzerland: a case series. BMC Pharmacol Toxicol. 2016 May 26;17(1):25. doi: 10.1186/s40360-016-0068-7. PubMed 27228985 ↗
  • Palamar JJ, Salomone A, Gerace E, Di Corcia D, Vincenti M, Cleland CM. Hair testing to assess both known and unknown use of drugs amongst ecstasy users in the electronic dance music scene. Int J Drug Policy. 2017 Oct;48:91-98. doi: 10.1016/j.drugpo.2017.07.010. Epub 2017 Aug 12. PubMed 28810159 ↗
  • Miliano C, Margiani G, Fattore L, De Luca MA. Sales and Advertising Channels of New Psychoactive Substances (NPS): Internet, Social Networks, and Smartphone Apps. Brain Sci. 2018 Jun 29;8(7):123. doi: 10.3390/brainsci8070123. PubMed 29966280 ↗
  • Robach P, Trebes G, Lasne F, Buisson C, Mechin N, Mazzarino M, de la Torre X, Roustit M, Kerivel P, Botre F, Bouzat P. Drug Use on Mont Blanc: A Study Using Automated Urine Collection. PLoS One. 2016 Jun 2;11(6):e0156786. doi: 10.1371/journal.pone.0156786. eCollection 2016. PubMed 27253728 ↗
  • Orsini J, Din N, Elahi E, Gomez A, Rajayer S, Malik R, Jean E. Clinical and epidemiological characteristics of patients with acute drug intoxication admitted to ICU. J Community Hosp Intern Med Perspect. 2017 Sep 19;7(4):202-207. doi: 10.1080/20009666.2017.1356189. eCollection 2017 Oct. PubMed 29046744 ↗
  • Helander A, Backberg M, Hulten P, Al-Saffar Y, Beck O. Detection of new psychoactive substance use among emergency room patients: results from the Swedish STRIDA project. Forensic Sci Int. 2014 Oct;243:23-9. doi: 10.1016/j.forsciint.2014.02.022. Epub 2014 Mar 6. PubMed 24726531 ↗
  • Spiller HA, Ryan ML, Weston RG, Jansen J. Clinical experience with and analytical confirmation of "bath salts" and "legal highs" (synthetic cathinones) in the United States. Clin Toxicol (Phila). 2011 Jul;49(6):499-505. doi: 10.3109/15563650.2011.590812. PubMed 21824061 ↗
  • Beck O, Franzen L, Backberg M, Signell P, Helander A. Toxicity evaluation of alpha-pyrrolidinovalerophenone (alpha-PVP): results from intoxication cases within the STRIDA project. Clin Toxicol (Phila). 2016 Aug;54(7):568-75. doi: 10.1080/15563650.2016.1190979. PubMed 27412885 ↗
  • Backberg M, Beck O, Hulten P, Rosengren-Holmberg J, Helander A. Intoxications of the new psychoactive substance 5-(2-aminopropyl)indole (5-IT): a case series from the Swedish STRIDA project. Clin Toxicol (Phila). 2014 Jul;52(6):618-24. doi: 10.3109/15563650.2014.920088. Epub 2014 Jun 4. PubMed 24895941 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04155281
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Nov 7, 2019
Start date
Jan 23, 2020
Primary completion
Jun 30, 2023
Completion
Oct 30, 2023
Last update
Nov 29, 2023

Study contacts

Damien VIGLINO, MD, PhD
principal investigator · University Hospital, Grenoble

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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