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

NCT ID: NCT06207396

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-05-31

Brief Summary

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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

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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.

Conditions

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Intoxication Unintended Ingestion of Product

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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serum and urine analysis

Spiking will be analyzed by immunoassay testing and high-resolution screening

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AZ Maria Middelares

Ghent, , Belgium

Site Status

Spoedgevallendienst AZ Jan Palfijn

Ghent, , Belgium

Site Status

Spoedgevallendienst AZ St. Lucas

Ghent, , Belgium

Site Status

Spoedgevallendienst

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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ONZ-2023-0004

Identifier Type: -

Identifier Source: org_study_id

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