NCT04155281

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 23, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

3.4 years

First QC Date

September 27, 2019

Last Update Submit

November 28, 2023

Conditions

Acute IntoxicationPsychoactive Substance Use

Keywords

Intoxication; Psychoactive Substance ; Ski

Outcome Measures

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.

    Day 0

Secondary Outcomes (5)

  • incidence of toxidromes

    baseline

  • polyintoxication frequency

    baseline

  • morbidity of intoxication

    baseline and month 1

  • morbidity of intoxication

    baseline and month 1

  • incidence of intoxication medical care

    day 1

Study Arms (1)

suspicion of intoxication

New Psychoactive Substances research in urine

Other: urine analysis

Interventions

urine analysisOTHER

New Psychoactive Substances research in urine at admission in unit care

suspicion of intoxication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Hospitalier Métropole Savoie (Chaméry)

Chambéry, Savoie, 73000, France

Location

CH Albertville Moutiers

Albertville, France

Location

University Hospital Grenoble

Grenoble, France

Location

Related Publications (17)

  • 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.

    PMID: 28834859BACKGROUND

  • 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.

    PMID: 28425277BACKGROUND

  • 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.

    PMID: 28199808BACKGROUND

  • 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.

    PMID: 27871332BACKGROUND

  • 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.

    PMID: 29668345BACKGROUND

  • 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.

    PMID: 27419383BACKGROUND

  • 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.

    PMID: 25522087BACKGROUND

  • 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.

    PMID: 29148866BACKGROUND

  • 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.

    PMID: 27228985BACKGROUND

  • 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.

    PMID: 28810159BACKGROUND

  • 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.

    PMID: 29966280BACKGROUND

  • 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.

    PMID: 27253728BACKGROUND

  • 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.

    PMID: 29046744BACKGROUND

  • 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.

    PMID: 24726531BACKGROUND

  • 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.

    PMID: 21824061BACKGROUND

  • 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.

    PMID: 27412885BACKGROUND

  • 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.

    PMID: 24895941BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine

MeSH Terms

Interventions

Urinalysis

Intervention Hierarchy (Ancestors)

Clinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalInvestigative Techniques

Study Officials

  • Damien VIGLINO, MD, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2019

First Posted

November 7, 2019

Study Start

January 23, 2020

Primary Completion

June 30, 2023

Study Completion

October 30, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

FR(3)