Clinical trial NCT06207396: Characteristics of Spiking in Ghent: a Multicentric Prospective Observational Study..
Official title: Characteristics of Spiking in Ghent: a Multicentric Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intoxication
Unintended Ingestion of Product
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult population (18+, all genders) presenting with alleged spiking to the emergency department

Brief 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;

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: What is the incidence of spiking in adult patients presenting to the emergency departments of the four Ghent hospitals with suspected spiking?
timeFrame: 19 months
measure: What is the type of product and mode of administration used in spiking
timeFrame: 19 months
measure: What are patient characteristics of patients with spiking
timeFrame: 19 months
measure: In what type of places does spiking occur in Ghent
timeFrame: 19 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Gent
country: Belgium
facility: Spoedgevallendienst AZ Jan Palfijn
city: Gent
country: Belgium
facility: Spoedgevallendienst AZ St. Lucas
city: Gent
country: Belgium
facility: Spoedgevallendienst
Study officials:
References: