New Psychoactive Substances in Intoxicated Patients During the Winter Activities

Psychoactive Substance Use Clinical Trial

— SkiTox  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04155281
• Other study ID #: 38RC19.214
• Secondary ID: 2019-A02214-53
• Status: Completed
• Start date: January 23, 2020
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: October 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Intoxication
• Psychoactive Substance Use
• Substance-Related Disorders

Intervention

Other:
• urine analysis
New Psychoactive Substances research in urine at admission in unit care

Locations

Country	Name	City	State
France	CH Albertville Moutiers	Albertville
France	Centre Hospitalier Métropole Savoie (Chaméry)	Chambéry	Savoie
France	University Hospital Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

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