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

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.

Study Overview

• Status: Completed
• Conditions: Poisoning by Psychoactive Substances
• Intervention / Treatment: Procedure: Sampling of a few drops of blood, lock of hair and urine

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Hopital Pellegrin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Interventional arm; Sampling of a few additional drops of blood and sending this sample for analysis and identification of a possible toxic cause by psychoactive substance in relation to the clinical picture presented by the patient; Oriented hair removal is also carried out if possible (small wick cut and not torn the size of a pencil mine of paper taken at the level of the occipital region). This technique has been used many times, and evaluates the previous consumption (memory consumption); A urine sample is taken if possible.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who have consumed new psychoactive substances	Number of patients who have consumed new psychoactive substances	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of toxidomas observed clinically	number of toxidomas observed clinically	Baseline
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
number of classes of new psychoactive substances found in the analyzes	number of classes of new psychoactive substances found in the analyzes	baseline
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Regional Health Agency New Aquitaine

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2017
• Primary Completion (ACTUAL): July 3, 2017
• Study Completion (ACTUAL): July 3, 2017

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (ACTUAL): June 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Poisoning; Psychoactive substances
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Poisoning
• Other Study ID Numbers: CHUBX 2017/12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No