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

NCT03203213 | Completed

• 1 other identifier: CHUBX 2017/12
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Poisoning by Psychoactive Substances

Keywords

Poisoning; Psychoactive substances

Outcome Measures

Primary Outcomes (1)

• Number of patients who have consumed new psychoactive substances

  Number of patients who have consumed new psychoactive substances

  baseline

Secondary Outcomes (4)

• number of toxidomas observed clinically

  Baseline

• number of patients who have previously used new psychoactive substances (hair, urine

  Baseline

• 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

  baseline

Study Arms (1)

Interventional arm

EXPERIMENTAL

* 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

Interventions

Sampling of a few drops of blood, lock of hair and urine PROCEDURE

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.

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Regional Health Agency New Aquitaine: collaborator

Study Sites (1)

Hopital Pellegrin

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Poisoning

Interventions

Urination

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: monocentric study

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 29, 2017
• Study Start: June 30, 2017
• Primary Completion: July 3, 2017
• Study Completion: July 3, 2017
• Last Updated: July 17, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)