Clinical trial NCT03203213: Musitox® Project: Consumption of Psychoactive Substances at Music Festivals in Aquitaine
Official title: Musitox® Project: Consumption of Psychoactive Substances at Music Festivals in Aquitaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poisoning by Psychoactive Substances
Keywords: Poisoning
Psychoactive substances
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Regional Health Agency New Aquitaine
First posted: 2017-06-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: monocentric study
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients who have consumed new psychoactive substances
timeFrame: baseline
Secondary outcomes:
measure: number of toxidomas observed clinically
timeFrame: Baseline
measure: number of patients who have previously used new psychoactive substances (hair, urine
timeFrame: Baseline
measure: number of classes of new psychoactive substances found in the analyzes
timeFrame: baseline
measure: severity evaluated secondarily from the clinical data sheets and according to poisoning severity score
timeFrame: baseline
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hopital Pellegrin
Study officials:
References: