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

Primary Purpose

Poisoning by Psychoactive Substances

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sampling of a few drops of blood, lock of hair and urine
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poisoning by Psychoactive Substances focused on measuring Poisoning, Psychoactive substances

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hopital Pellegrin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of patients who have consumed new psychoactive substances
Number of patients who have consumed new psychoactive substances

Secondary Outcome Measures

number of toxidomas observed clinically
number of toxidomas observed clinically
number of patients who have previously used new psychoactive substances (hair, urine
number of patients who have previously used new psychoactive substances (hair, urine
number of classes of new psychoactive substances found in the analyzes
number of classes of new psychoactive substances found in the analyzes
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

Full Information

First Posted
June 27, 2017
Last Updated
July 12, 2017
Sponsor
University Hospital, Bordeaux
Collaborators
Regional Health Agency New Aquitaine
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1. Study Identification

Unique Protocol Identification Number
NCT03203213
Brief Title
Musitox® Project: Consumption of Psychoactive Substances at Music Festivals in Aquitaine
Acronym
Musitox®
Official Title
Musitox® Project: Consumption of Psychoactive Substances at Music Festivals in Aquitaine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
July 3, 2017 (Actual)
Study Completion Date
July 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Regional Health Agency New Aquitaine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poisoning by Psychoactive Substances
Keywords
Poisoning, Psychoactive substances

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
monocentric study
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sampling of a few drops of blood, lock of hair and urine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients who have consumed new psychoactive substances
Description
Number of patients who have consumed new psychoactive substances
Time Frame
baseline
Secondary Outcome Measure Information:
Title
number of toxidomas observed clinically
Description
number of toxidomas observed clinically
Time Frame
Baseline
Title
number of patients who have previously used new psychoactive substances (hair, urine
Description
number of patients who have previously used new psychoactive substances (hair, urine
Time Frame
Baseline
Title
number of classes of new psychoactive substances found in the analyzes
Description
number of classes of new psychoactive substances found in the analyzes
Time Frame
baseline
Title
severity evaluated secondarily from the clinical data sheets and according to poisoning severity score
Description
severity evaluated secondarily from the clinical data sheets and according to poisoning severity score
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hopital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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