Toxicological Analysis in Chemical Submission (TANCS)

The purpose of this study is to carry out a systematic toxicological analysis of all the patients, examined at the UMJ of the Hôtel-Dieu following a complaint for suspected chemical submission. By comparing the toxicological data with the clinical examination data (e.g. treatment intake), the investigators could determine the number of confirmed chemical submissions and the substances involved.

Study Overview

• Status: Completed
• Conditions: Chemical Submission
• Intervention / Treatment: Other: Toxicological analysis

Detailed Description

The number of chemical submissions has been constantly increasing in France for several years. The Parisian Center of Evaluation and Information on Pharmacodependence and Addictovigilance collects notifications of chemical submissions demonstrated by toxicological analyses. For the year 2017, 544 notifications were received by this structure. For cases of probable chemical submission, drugs were involved in more than 75% of cases, mostly benzodiazepines. In Europe, there are few cohort studies on the toxicological analysis of suspected chemical submissions. A systematic review of the literature carried out in 2017 by Anderson et al. reports that most studies deal with isolated cases of chemical submission involving a specific and unusual psychoactive substance or are in fact toxicological studies aiming to develop a new analytical technique concerning a substance. Few relevant European cohort studies on this subject have been carried out and most of them are more than ten years old. The Medico-Judicial Unit of the Hôtel-Dieu (UMJ) receives victims of chemical subjection following the filing of a complaint, upon judicial requisition. Complaints can concern a suspicion of chemical submission alone, or a suspicion of chemical submission associated with a suspicion of sexual assault or a robbery. In these cases, the judicial requisition systematically includes a request for toxicological samples (blood and urine). Depending on the data of the investigation, the judicial authority will decide to have the toxicological analyses of these samples performed. In 2018, at the UMJ of Hôtel-Dieu, 231 conservative samples were taken in cases of suspected chemical submissions. As of the writing of this work (November 2019), only 72 samples have been sealed by the judicial authority, i.e. 31.2% of the cases. Moreover, the results of these analyses are not systematically communicated to the UMJ of the Hôtel-Dieu de Paris nor to the patients. Each year, the Medico-Judicial Unit (UMJ) of the Hôtel-Dieu Hospital in Paris receives between 12,000 and 15,000 alleged victims of criminal offences following their filing of a complaint for medical examination on judicial requisition. Among this population, our study will specifically focus on adults who have filed a complaint for suspected chemical submission. The investigators would like to carry out a systematic toxicological analysis of all the patients who have been examined at the UMJ of the Hôtel-Dieu following a complaint for suspected chemical submission. By comparing the toxicological data with the clinical examination data (e.g. treatment intake), the investigators could determine the number of confirmed chemical submissions and the substances involved. This work has several interests. It would allow us to refine our knowledge of the substances used in chemical submissions, and to determine a possible specificity of the substances used in Paris by comparing our data with those existing in the medical literature, at the European and global levels. The data concerning the proven chemical submissions would be transmitted to the CEIP-A, thus allowing an active participation in the toxicovigilance network. A high number of proven chemical submissions would also alert the judicial authorities to the need to carry out toxicological analyses in a more systematic way. Finally, the investigators will systematically propose to the patients included in the study that they receive their results during the follow-up consultation, which is usually carried out within 3 months of the initial consultation. This last point will allow us to improve the management of these patients, by providing them with the answers necessary for the psychological reconstruction process.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • IDF
    • Paris, IDF, France, 75004
      • Hôtel-Dieu Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Alleged victims of criminal offences following their filing of a complaint for medical examination on judicial requisition, seen in the Medico-Judicial Unit (UMJ) of the Hôtel-Dieu Hospital in Paris, France.

Description

Inclusion Criteria:

• Be of legal age (≥ 18) on the day of the exam,
• Have filed a complaint for a suspected chemical chemical,
• Be in possession of a judicial requisition requesting the to take biological samples (blood and urine)
• Claim to be the victim of a suspected chemical chemical submission that took place less than 5 days before the consultation,
• Be affiliated or entitled to a social security system,
• Having been informed of the research and not having opposed to his participation.

Exclusion Criteria:

• Patient under court protection
• Minor patient (< 18 ans),
• Patient under guardianship,
• Patient who does not speak French,
• Patient with psychotic / cognitive symptoms that may impair their judgment,

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chemical Submission; Patients with a suspected chemical submission	Other: Toxicological analysis; Automated enzymatic assays Automated Immunoassay Urine Screening High Resolution Toxicological Screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of one or more psychoactive substances	Identify the presence of one or more psychoactive substances in the tests performed (blood).	Day of inclusion
Presence of one or more psychoactive substances	Identify the presence of one or more psychoactive substances in the tests performed (urines).	Day of inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire	Questionnaire to identify if voluntary intake of one or more psychoactive substance(s) within 24 hours leading to the suspicion of chemical submission.	Day of inclusion
Quantification of ethanol	Quantification of ethanol and/or ethylglucuronide (its metabolite) in samples	Day of inclusion
Quantification of ethylglucuronide	Quantification of ethanol and/or ethylglucuronide (its metabolite) in samples	Day of inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: DUFAYET Laurène, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): April 15, 2022
• Study Completion (Actual): July 27, 2022

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: psychoactive substances; Toxicological analysis; chemical submission; date rape drug
• Other Study ID Numbers: APHP200054; 2019-A03134-53 (Other Identifier: ANSM)

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