Musitox® Project: Consumption of Psychoactive Substances at Music Festivals in Aquitaine

Poisoning by Psychoactive Substances Clinical Trial

— Musitox®  

Official title:

Musitox® Project: Consumption of Psychoactive Substances at Music Festivals in Aquitaine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203213
• Other study ID #: CHUBX 2017/12
• Status: Completed
• Phase: N/A
• First received: June 27, 2017
• Last updated: July 12, 2017
• Start date: June 30, 2017
• Est. completion date: July 3, 2017

Study information

• Verified date: July 2017
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Poisoning by psychoactive substances is increasingly common in Europe and can be responsible for deaths. These substances, also called "festive drugs", circulate among other places in festive gatherings (night clubs, concerts, free music, feria, etc.). The main objective of this study is to determine the molecules that circulate in festive events in Aquitaine, in order to implement prevention actions by looking at whether the circulating substances vary with the style of event.

Description:

Poisoning by psychoactive substances is increasingly common in Europe and can be responsible for deaths. These substances, also called "festive drugs", circulate among other places in festive gatherings (night clubs, concerts, free music, feria, etc.).

There is also a significant increase in the number of new psychoactive substances (NSPs) whose toxicity is unknown: by 2014, 101 new substances were detected for the first time in Europe. These molecules, because of this regular and rapid emergence, are not included in the narcotics list, in the great majority of cases.

Poison control centers, as well as addictovigilance centers, are regularly called upon for serious poisoning resulting in hospitalization, for which analytical evidence is most often missing or difficult to obtain. The lack of documentation, both analytical and clinical, of these files limits its expertise. As a result, medical knowledge, in particular clinical knowledge, progresses little which limits the efficiency of the management of these poisonings.

A 2015 pilot study on the Dax and Mont-de-Marsan (FERIATOX) fertilization sites on 27 patients showed that although several psychoactive substances have been identified in these patients (cocaine, ketamine, MDMA, cannabis, etc.) No DK was identified in this study. It is possible, however, that the profile of people who frequent ferias is different from that of music festivals, which explains the lack of identification of these substances in the FERIATOX study. To support this hypothesis, it seems important to renew this study on festive events of the type of music festival. The Garorock Festival (Marmande), held at the beginning of July, seems to be relevant for the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 3, 2017
• Est. primary completion date: July 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any patient admitted to the Emergency Medical Post with neurological and / or behavioral disorders:

• agitated at the time of admission to the PMA or during surveillance at the LDC

• and who will say (or for whom his entourage will say that he has) consumed psychoactive substances

• or who will be unable to say that they have taken a psychoactive substance and for which no other etiology is evident

• and / or for which the seriousness of the case necessitates admission to the emergency or intensive care, whether or not the physician is aware of a psychoactive substance (and in the absence of an obvious etiology)

• and / or if the PMA physician considers that analytical research is needed for further care

• Oral Express Consent

• any patient who is in possession of an identity document proving his / her majority (over 18 years).

Exclusion Criteria:

• Refusal of the patient to take a sample, or to participate in the study

• Minors (under 18 years of age)

• Pregnant women

• Breastfeeding women

• Patient who can not prove his / her age by the production of an identity document.

Related Conditions & MeSH terms

• Poisoning
• Poisoning by Psychoactive Substances

Intervention

Procedure:
• Sampling of a few drops of blood, lock of hair and urine
Sampling of a few additional drops of blood to deposit them on blotting paper (DBS: Dried Blood Spot) ad hoc and to send this sample for analysis and identification of a possible toxic cause by psychoactive substance in relation to the clinical picture presented by the patient. An oriented capillary sampling is also performed if possible. Similarly a urine sample is taken if possible.

Locations

Country	Name	City	State
France	Hopital Pellegrin	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Agence Régionale de Santé Nouvelle Aquitaine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who have consumed new psychoactive substances	Number of patients who have consumed new psychoactive substances	baseline
Secondary	number of toxidomas observed clinically	number of toxidomas observed clinically	Baseline
Secondary	number of patients who have previously used new psychoactive substances (hair, urine	number of patients who have previously used new psychoactive substances (hair, urine	Baseline
Secondary	number of classes of new psychoactive substances found in the analyzes	number of classes of new psychoactive substances found in the analyzes	baseline
Secondary	severity evaluated secondarily from the clinical data sheets and according to poisoning severity score	severity evaluated secondarily from the clinical data sheets and according to poisoning severity score	baseline