Characteristics of Spiking in Ghent: a Multicentric Prospective Observational Study..

Intoxication Clinical Trial

Official title:

Characteristics of Spiking in Ghent: A Multicentric Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06207396
• Other study ID #: ONZ-2023-0004
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: January 2024
• Source: University Hospital, Ghent
• Contact: Cathelijne Lyphout, MD
• Phone: 093322111
• Email: cathelijne.lyphout[@]uzgent.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to document the incidence and characteristics of spiking in the Ghent region, both anamnestically and by toxicological analysis.

Spiking will be analyzed by immunoassay testing and high-resolution screening according to the protocol in the laboratory of UZ Gent;

Description:

This study aims at objectivating and characterizing the patients with alleged spiking in the city of Ghent.

Every patient who presents at one of the four (out of four) emergency departments of Ghent, with a suspicion of spiking (drink/food/needle-spiking included), will be offered to take part of this study.

The study entails a list of questions for the patient regarding demographics, recent own medication/drug/alcohol use and experienced symptoms; whilst the caregiver (doctor/nurse) completes a questionnaire regarding symptoms at time of presentation.

For a presentation within 48h after event, both blood and urine samples are requested from the patient. When presenting between 48h and 96h after the event, only urine samples are requested.

On this samples, IA and LC-GCMS according to the UNODOC standards ("Guidelines for the Forensic analysis of drugs facilitating sexual assault and other criminal acts") to objectify exogenous products.

On request of the patient, these results can be added to the medical file of the patient.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 years

• Patient self-reports suspicion of spiking OR there is a suspicion of spiking by physician, police, paramedics or patient's companions

• willingness to provide urine and/or blood samples (depending on timing after event)

Exclusion Criteria:

• Reporting more than 5 days after spiking

• Unable to reliably complete the questionnaire (can be after clinical observation/recovery).

• Not declaring proficiency in the language in which informed consent is offered (Dutch/English).

• Not agreeing to the informed consent.

• Do not consent to blood and urine collection and/or analysis.

• There is a suspicion of Drug Facilitated Sexual Assault (to be referred to Care Center Sexual Violence, ZSG, where parallel study is ongoing).

Related Conditions & MeSH terms

• Intoxication

Intervention

Diagnostic Test:
• serum and urine analysis
Spiking will be analyzed by immunoassay testing and high-resolution screening

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Gent
Belgium	Spoedgevallendienst	Gent
Belgium	Spoedgevallendienst AZ Jan Palfijn	Gent
Belgium	Spoedgevallendienst AZ St. Lucas	Gent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	What is the incidence of spiking in adult patients presenting to the emergency departments of the four Ghent hospitals with suspected spiking?	Number of patients presenting to the ED with spiking	19 months
Primary	What is the type of product and mode of administration used in spiking	Defining type of products and mode of administration	19 months
Primary	What are patient characteristics of patients with spiking	Demographic features of the patients diagnosed with spiking	19 months
Primary	In what type of places does spiking occur in Ghent	Location of spiking event	19 months