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Completed

NCT Number: NCT06207396

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

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;

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Maria Middelares, Ghent, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

serum and urine analysis

Diagnostic Test

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

Primary outcomes

  1. What is the incidence of spiking in adult patients presenting to the emergency departments of the four Ghent hospitals with suspected spiking?

    Time frame: 19 months

    Number of patients presenting to the ED with spiking

  2. What is the type of product and mode of administration used in spiking

    Time frame: 19 months

    Defining type of products and mode of administration

  3. What are patient characteristics of patients with spiking

    Time frame: 19 months

    Demographic features of the patients diagnosed with spiking

  4. In what type of places does spiking occur in Ghent

    Time frame: 19 months

    Location of spiking event

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Characteristics of Spiking in Ghent: A Multicentric Prospective Observational Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2024
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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