GCS Survey: "GHB IN CHEMICAL SUBMISSION: MYTH OR REALITY?"

NCT06137599 | Recruiting

• 1 other identifier: APHP230579
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

According to the media, GHB is the main substance used for chemical submission. The national survey conducted by the Addictovigilance centre of Paris on drug-facilitated assaults shows that GHB is used, but only in a very small proportion of cases. However, the short detection times for this substance point to its possible under-detection (06-09h in blood, 10-12h in urine). A pilot research protocol in Ile de France focusing on capillary analysis is therefore being proposed to volunteer victims to overcome this bias and answer this question: is the massive use of GHB in chemical submission a myth or a reality?

Conditions

CHEMICAL SUBMISSION

Keywords

CHEMICAL SUBMISSION; Chemical vulnerability; Drug facilitated Crime; Gamma hydroxybutyrate; Capillary analysis

Outcome Measures

Primary Outcomes (1)

• Evidence of exogenous GHB intake without the knowledge of the victims through hair analysis.

  A double CEIP-A/Expert Laboratory interpretation is carried out according to the evaluation criteria defined by the national chemical submission survey Steering Committee.

  Samples taken between 2 and 6 months after the presumed events: GHB analysis in the hair can no longer be interpreted after 6 months due to the hydrosoluble nature of GHB and repetitive hair washing.

Secondary Outcomes (1)

• Evidence of the use of a psychoactive substance (other than GHB) without the knowledge of the victims via capillary analysis.

  Samples taken between 2 and 6 months after the presumed events.

Interventions

Capillary analysis OTHER

Samples taken between 2 and 6 months after the presumed events. A pre-analytical treatment of the hair (washing, fragmentation), followed by detection by high-resolution mass spectrometry is carried out by an expert laboratory to search for both GHB and psychoactive drugs.

Eligibility Criteria

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

Study Population

Any person suspecting of having been the victim of chemical submission (attack after taking a substance without the victims' knowledge or under threat

You may qualify if:

• Victims over the age of majority (≥ 18 years) on the day of the alleged events
• With a medical history leading to the suspicion of chemical submission:
• Presence of evocative clinical signs (amnesia and/or behavioural disorders and/or neurological disorders and/or other somatic disorders, etc.) AND
• In the presence of potential criminal acts (suspected or proven assault or attempted assault).
• French speaking
• Having been informed of the search

You may not qualify if:

• \- Victims who were minors (\<18 years) on the day of the alleged events.
• Victims who usually use GHB/GBL recreationally.
• Suspecting administration of a harmful substance with no crime or offence committed at the time and no attempted assault
• Victims of needle spiking
• Victims with very short hair (\<3 cm), bald or shaven heads
• Victims who have exceeded the maximum time limit for taking a hair sample (6 months after the event)
• Do not speak French
• Oppose to participating in the study
• Victims presenting a psychotic or cognitive syndrome likely to impair judgement Victims placed under guardianship or legal protection (article L11-22-2 CSP)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Mission Interministérielle de Lutte contre les Drogues et les Conduites Addictives - MILDECA: collaborator

Study Sites (3)

Laetitia LASNE

Bondy, 93140, France

RECRUITING

Elisabeth ALCARAZ

Paris, 75004, France

RECRUITING

Leila CHAOUACHI

Paris, 75010, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

capillary sampling and analysis

Study Officials

• Leïla CHAOUACHI, PharmD

  APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS

  STUDY CHAIR

• Anne Batisse, PharmD

  APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS

  STUDY DIRECTOR

Central Study Contacts

Leïla CHAOUACHI, PharmD

CONTACT

01 40 05 42 70; Leila.chaouachi@aphp.fr

Anne Batisse, PharmD

CONTACT

01 40 05 42 65; anne.batisse@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: March 20, 2024
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)